CDSCO Flags 112 Drug Batches Including Telmisartan, Pantoprazole, Cefixime, Glimepiride as Not of Standard Quality

Written By :  Susmita Roy
Published On 2025-10-25 08:23 GMT   |   Update On 2025-10-25 08:23 GMT
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New Delhi: The Central Drugs Standard Control Organization (CDSCO) has identified 94 batches of medicines and medical products as "Not of Standard Quality" (NSQ) after samples tested in September 2025 by its central and state laboratories failed to meet required pharmacopeial and safety standards.

The flagged products cover a wide range of therapeutic categories, including antibiotics, analgesics, antipyretics, antidiabetics, and other essential medicines.

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These include Glimepiride Tablets IP 1 mg, manufactured by Karnataka Antibiotics and Pharmaceuticals, Telmisartan tab I.P. 40 mg, manufactured by Helax Healthcare, Bromhexine Hydrochloride Tablets IP 4 mg, manufactured by J.P. Industries, Rabeprazole Sodium Injection IP, manufactured by Martin & Brown Bio-Sciences, Dexamethasone Injection I.P., manufactured by SGS Pharmaceuticals, Pantoprazole Tablets I.P,. manufactured by Healers Lab, Cefixime Tablets IP 200 mg, manufactured by SVR Healthcare, and others.

The list further includes Diclofenac Sodium and Paracetamol Tablets IP manufactured by Zydus Healthcare, Clobetasol Propionate Neomycin Sulfate and Miconazole Nitrate Cream manufactured by Macleods Pharmaceuticals, Ivabradine Tablets 5 mg manufactured by Hetero Labs.

This came as part of the continuous regulatory surveillance, where drug samples are picked from sales/distribution points, analyzed, and lists of Not of Standard Quality (NSQ) drugs are displayed on the CDSCO portal on a monthly basis.

The reasons for failure varied across samples — the most frequent being assay failure (active ingredient content outside permissible limits), dissolution issues, pH deviations, and sterility test failures in parenteral preparations. A few samples were also flagged for visual defects and labeling discrepancies, marking regulatory non-conformance.

The CDSCO report also noted that several states and Union Territories did not furnish any data for the Not of Standard Quality (NSQ) Drug Alert for the month of September 2025. The states and UTs that remain pending in submission include Andaman and Nicobar Islands, Arunachal Pradesh, Assam, Bihar, Chandigarh, Chhattisgarh, Dadra and Nagar Haveli, Daman and Diu, Delhi, Goa, Jammu and Kashmir, Jharkhand, Kerala, Ladakh, Lakshadweep, Manipur, Meghalaya, Mizoram, Nagaland, Odisha, Puducherry, Tamil Nadu, and Tripura.

Drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs. The term ‘standards of quality’ is defined under Section 16 (1) (a) of the Drugs and Cosmetics Act, 1940, as ‘standards of quality’, meaning that the drug complies with the standards set out in the Second Schedule of the said Act.

NOT OF STANDARD QUALITY (NSQ) ALERT FOR THE MONTH OF SEPTEMBER 2025

S.No

Name of Product

Batch No

Manufacturing Date

Expiry Date

Manufactured By

NSQ Result

Reporting Source

Reporting by Lab/State

Reporting Month & Year

1

Glimepiride Tablets IP 1 mg

12800524

Mar-2024

Feb-2026

Karnataka Antibiotics And Pharmaceuticals Ltd Plot No.14, II Phase,Peenya,Bengaluru-560058

sample does not conform to I.P with respect to the test for Related substances.

CDSCO Labs

CDTL, Indore

SEP-2025

2

SPADE SERRATIOPEPTIDASE TABLETS IP 5 mg

ISP122

May-2025

Apr-2027

Med Manor Organics Pvt.Ltd. Unit-II, Kh. No.143M/7 Village-Raipur Pagwana Bhagwanpur, Tehsil-Roorkee, Distt.Haridwar, Uttarakhand-247661.

sample received does not conform to the I.P. 2022 standard with respect to Assay of Serratiopeptidase

CDSCO Labs

CDTL, Mumbai

SEP-2025

3

MECOSOL-Plus Capsules Mehtylcobalamin, Alpha Lipoic acid, Folic Acid, Pyridoxine HCl & Thiamine Mononitrate Capsules

VGC240264B

Jul-2024

Jun-2026

Vrindavan Global Plot No. 23-B &C, Ind. Area Lodhimajra, Baddi, Distt. Solan (H.P.) 173205

sample does not conforms to Manufacturers specification with respect to the Tests for Disintegration ,Uniformity of weight and Assay of Alpha Lipoic Acid and Folic acid.

CDSCO Labs

CDTL, Mumbai

SEP-2025

4

Albendazole Tablets IP

PGT25451

Jun-2025

May-2028

Affy Parenterals (WHO- cGMP/ISO 9001:2015 Certified Co.) Vill. Gullerwala, P.O. Baddi, Distt. Solan- 173 205 (HP)

Dissolution

State Lab

SDTL Raipur Chhattisgarh

SEP-2025

5

Diclofenac Sodium and Paracetamol Tablets IP

I405175

Oct-2024

Sep-2026

Zydus Healthcare Ltd.,(Unit II) 967 (P), 968 (P), 970 (P), Duga Circle, Kamarey Bhasmay, Kumrek, Sikkim-737132

Assay & Dissolution

State Lab

Government of NCT of Delhi

SEP-2025

6

Tamoxifen Tablets IP

SPOT250033

Mar-2025

Feb-2027

Salus Pharmaceuticals 480/211, Harraipur, PO Gurumajra,Teh Baddi, Distt.Solan (H.P.) 173205

Test for Dissolution

State Lab

Government of NCT of Delhi

SEP-2025

7

Amoxycillin & Potassium Clavulana Tablet I.P

MFK0722

Sep-2024

Aug-2026

Medicef Pharma, Plot No. 28, 29 & 48, Phase-I, EPIP, Jharmajri, Baddi, Dist. Solan - 173205, (H.P.)

Spurious.

State Lab

SDTL, Kolkata, West Bengal.

SEP-2025

8

TELMISARTAN TAB I.P. 40 MG.

GT-2502

Mar-2025

Feb-2027

Helax Healthcare Pvt. Ltd., Khasra No. 410, Vill. Karondi, Haridwar.

Description

State Lab

SDTL, Kolkata, West Bengal.

SEP-2025

9

TELMISARTAN TAB I.P. 40 MG.

GT-2504

Mar-2025

Feb-2027

Helax Healthcare Pvt. Ltd., Khasra No. 410, Vill. Karondi, Haridwar.

Description

State Lab

SDTL, Kolkata, West Bengal.

SEP-2025

10

CALXIA Calcium Carbonate 500 MG + VIT. D3 250 IU Tablets IP

GTA 1350

Jan-2025

Dec-2026

Gidsha Pharmaceuticals Plot No. 611 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat

Dissolution

CDSCO Labs

CDL, Kolkata

SEP-2025

11

CALXIA Calcium Carbonate 500 MG + VIT. D3 250 IU Tablets IP

GTA1342

Jan-2025

Dec-2026

Gidsha Pharmaceuticals Plot No. 611 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat

sample does not conform to claim as per IP 2022 in respect to the Test of Dissolution (for Calcium)

CDSCO Labs

CDL, Kolkata

SEP-2025

12

Bromhexine Hydrochloride Tablets IP 4 mg

TBH4-015

Mar-2025

Feb-2028

J.P. Industries Bhud, Baddi, Distt. Solan, H.P. India

sample does not conform to I.P. with respect to the "Assay of Bromhexine Hydrochloride".

CDSCO Labs

CDL, Kolkata

SEP-2025

13

Iron Sucrose Injection USP 100 mg

24RS15

Dec-2024

Nov-2026

SAI Parenterals Limited, D1&D4, Survey No.280,Phase-V, IDA,Jeedimetla, Hyderabad-500055, Telangana, India

sample does not conform to U.S.P. with respect to the Test for "Content of chloride" "pH", and "Alkalinity".

CDSCO Labs

CDL, Kolkata

SEP-2025

14

CALXIA Calcium Carbonate 500 MG + VIT. D3 250 IU Tablets IP

GTA1344

Jan-2025

Dec-2026

Gidsha Pharmaceuticals Plot No. 611 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat

sample does not conform to IP with respect to the Dissolution (for Calcium) test.

CDSCO Labs

CDL, Kolkata

SEP-2025

15

CALXIA Calcium Carbonate 500 MG + VIT. D3 250 IU Tablets IP

GTA1341

Jan-2025

Dec-2026

Gidsha Pharmaceuticals Plot No. 611 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat

sample does not conform to IP with respect to the Dissolution (for Calcium) test.

CDSCO Labs

CDL, Kolkata

SEP-2025

16

CALXIA Dicyclomine Hydrochloride Tablets IP 10 mg..

QT0210

Jun-2024

May-2026

Quest Laboratories Limited Plot No. 45, Sector-III, Pithampur, Dist. Dhar- 454775 (M.P.)

sample does not conform to IP with respect to the Test of Description.

CDSCO Labs

CDL, Kolkata

SEP-2025

17

Rabeprazole Sodium Injection IP

MD24G41

Jul-2024

Jun-2026

Martin & Brown Bio-Sciences Pvt. Ltd.. K.No. 918/419, Malkumajra, Nalagarh Road, Baddi, Dist.Solan (H.P.)-173205

sample does not conform to IP 2022 with respect to test for "pH", "Particulate matter", "Clarity of solution" and "Description".

CDSCO Labs

CDL, Kolkata

SEP-2025

18

Dexamethasone Injection I.P.

NSD24005

Jun-2024

May-2026

SGS Pharmaceuticals Pvt. Ltd. 162/1Puhana Iqbalpur Road, Nanhera , Roorkee - 247 667(Uttarakhand)

sample does not conform to IP with respect to test for "Particulate matter", "Assay/content of Dexamethasone Phosphate" and "Description".

CDSCO Labs

CDL, Kolkata

SEP-2025

19

CALXIA Calcium Carbonate 500 MG + VIT. D3 250 IU Tablets IP

GTA 1343

Jan-2025

Dec-2026

Gidsha Pharmaceuticals Plot No. 611 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat

sample does not conform to claim as per IP 2022 in respect to the Test of Dissolution (for Calcium)

CDSCO Labs

CDL, Kolkata

SEP-2025

20

CALXIA Calcium Carbonate 500 MG + VIT. D3 250 IU Tablets IP

GTA1355

Jan-2025

Dec-2026

Gidsha Pharmaceuticals Plot No. 611 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat

sample does not conform to claim as per IP 2022 in respect to the Test of Dissolution (for Calcium)

CDSCO Labs

CDL, Kolkata

SEP-2025

21

CALXIA Calcium Carbonate 500 MG + VIT. D3 250 IU Tablets IP

GTA1339

Jan-2025

Dec-2026

Gidsha Pharmaceuticals Plot No. 611 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat

sample does not conform to IP with respect to the Dissolution (for Calcium) test.

CDSCO Labs

CDL, Kolkata

SEP-2025

22

Telmisartan Tablets I.P. 40 mg..

BPLT-25010

Jan-2025

Dec-2026

Bennet Pharmaceuticals Ltd. Village Chanal Majra, Nr. Manpura, BADDI, Tal. Nalagarh, Distt. Solan (H.P.) - 173205.

sample is declared to be Not of standard quality for the reason stated under Description.

CDSCO Labs

CDL, Kolkata

SEP-2025

23

LUPIGESIC Buprenorphine Injection IP 2ml

ASG 1590

Nov-2022

Oct-2026

SNG Pharmaceuticals (p) Ltd., 101/B.K.B Complex Opp. Mahavir Nagar, N.H.No. 8, Vapi-396191 At 75/1 G.I.D.C, Vapi-396195

sample does not conform to I.P. with respect to test for "Sterility", "Related substances", "Particulate matter", "Assay/content of Buprenorphine and "Description".

CDSCO Labs

CDL, Kolkata

SEP-2025

24

CALXIA Calcium Carbonate 500 MG + VIT. D3 250 IU Tablets IP

GTI1094

Sep-2024

Aug-2026

Gidsha Pharmaceuticals Plot No. 611 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat

sample does not conform to IP with respect to the test of Dissolution (for Calcium).

CDSCO Labs

CDL, Kolkata

SEP-2025

25

AZEN-20 Rabeprazole Tablets IP

ZTL-157

Dec-2024

Nov-2026

Zoic Biotech Pvt. Ltd. Plot No. C-15, Focal Point, Ind. Area, Chanalon, Mohali (Punjab) 140103

sample does not conform to IP with respect to test for Dissolution Acid Stage and Dissolution Buffer Stage.

CDSCO Labs

CDL, Kolkata

SEP-2025

26

Ampicillin Injection IP 500mg

24AP2341

Oct-2024

Sep-2026

Pharma Impex Laboratories Pvt. Ltd. (ISO 9001 : 2015 & WHO GMP Certified) South Uttarbhag, Ramanagr, Baruipur, Dist. South 24PGS, WB. - 743387 INDIA

sample does not conform to I.P with respect to Particulate matter & Clarity Of Solution.

CDSCO Labs

CDL, Kolkata

SEP-2025

27

Telmisartan Tablets IP 40 mg

BPLT-24305

Oct-2024

Sep-2026

Bennet Pharmaceuticals Ltd. Village Chanal Majra, Nr. Manpura, BADDI, Tal. Nalagarh, Distt. Solan (H.P.) - 173205.

sample is not of standard quality for the reason stated under Description.

CDSCO Labs

CDL, Kolkata

SEP-2025

28

CALXIA Calcium Carbonate 500 MG + VIT. D3 250 IU Tablets IP

GTA1356

Jan-2025

Dec-2026

Gidsha Pharmaceuticals Plot No. 611 612, Mega GIDC, Kharedi, Dahod 389151, Gujarat

sample does not conform to claim as per IP 2022 in respect to the Test of Dissolution (for Calcium)

CDSCO Labs

CDL, Kolkata

SEP-2025

29

Amoxycillin & Potassium Clavulanate Injection IP 1200 mg

D0092461A

Dec-2024

Nov-2026

Protech Telelinks Mouza Ogli, Suketi Road, Kala Amb, Distt. Sirmour-173030 (H.P.)

sample does not conform to IP with respect to the Assay of Clavulanic Acid

CDSCO Labs

CDL, Kolkata

SEP-2025

30

Bupivacaine Injection IP

L2022410B

Oct-2024

Sep-2026

Protech Telelinks Mouza Ogli, Suketi Road, Kala Amb, Distt. Sirmour-173030 (H.P.)

sample does not conform to IP with respect to test for "Particulate matter" and "Description".

CDSCO Labs

CDL, Kolkata

SEP-2025

31

Pimecrolimus IH

PMS0125008

Jul-2025

Jun-2028

Sumar Biotech LLP, Plot No: 112,113,114, GIDC Estate Gozariya, Ta & Dist: Mehsana-382825, Gujarat, India

sample does not conform to manufacturers specification with respect to the content of Ethyl acetate of residual solvents.

CDSCO Labs

CDL, Kolkata

SEP-2025

32

FECOPOD Cefpodoxime Proxetil Tablets 200 mg

TBL-114

Mar-2024

Feb-2026

Ticoma Pharmacia.. E-17, Industrial Focal Point, Derabassi - 140 507 (Pb.).

sample does not conform to I.P. with respect to Dissolution of Cefpodoxime.

CDSCO Labs

CDL, Kolkata

SEP-2025

33

Moxilase-CV Amoxycillin & Potassium Clavulanate Injection IP

B24154

Nov-2024

Apr-2026

Rica Enterprises, Vill. Khari, Mauza Ogli, Kala Amb, DIstt. Sirmour- 173030 H.P.

Test of Clarity of solution, Particulate matter, and Assay of Potassium Clavulanate equivalent to Clavulanic Acid

CDSCO Labs

CDL, Kolkata

SEP-2025

34

KOBALA PLUS Alpha Lipoic Acid 300mg & Methylcobalamin 1500mcg Capsules

DAL401

Jul-2024

Jun-2026

Synmedic Laboratories SP-3-5 A And C, RIICO Industrial Area Keshwana, Kotputli, Jaipur, Rajasthan-303108.

sample does not conform to claim in respect to the Test of Description.

CDSCO Labs

CDL, Kolkata

SEP-2025

35

Pantoprazole Tablets IP 40 mg

0111

Dec-2024

Nov-2026

Hindustan Antibiotics Ltd. (A Govt. of India Enterprise) Pimpri, Pune - 411 018, INDIA.

sample does not conform to IP with respect to test for Dissolution (Buffer Stage).

CDSCO Labs

CDL, Kolkata

SEP-2025

36

Pdzole -40 Tablets Pantoprazole Gastro Resistant Tablets IP 40 mg

ZBT-7770

Sep-2024

Jul-2026

Zoic Biotech Pvt. Ltd. Plot No. C-15, Focal Point, Ind. Area, Chanalon, Mohali (Punjab) 140103

sample does not conform as per I.P. 2022 with respect to the test for "Dissolution in Buffer Stage" for Pantoprazole.

CDSCO Labs

RDTL, Guwahati

SEP-2025

37

Ofloxacin & Ornidazole Tablets I.P..

OZH-2501

Apr-2025

Mar-2027

Apple Formulations Pvt. Ltd. . Plot No.208, Kishanpur, Roorkee- 247667(U.K.)

sample does not comply as per I.P. 2022 with respect to the test for "Dissolution" of Ofloxacin and Ornidazole.

CDSCO Labs

RDTL, Guwahati

SEP-2025

38

Savtel Telmisartan Tablets IP 40 mg.

PT-40585

Feb-2024

Jan-2026

Pharmaroots Healthcare Khasra No. 411, Village Tipra, P.O. Barotiwala, Tehsil Baddi, Distt. Solan, H.P.

sample does not conform to claim as per I.P. 2022 in respect to the Test of Dissolution

CDSCO Labs

RDTL, Guwahati

SEP-2025

39

GREEN SAFE DELUX Infusion Set

24050016

May-2024

Apr-2027

Upico Medicare Pvt. Ltd PLOT.NO.17, Karmbhumi ,INDL. ESTATE, Bakrol,Distt, Ahmedabad, Gujarat

sample does not comply as per I.P. 2022 with respect to the test for "Sterility"

CDSCO Labs

RDTL, Guwahati

SEP-2025

40

Pantoprazole Tablets I.P..

PAA-528

Apr-2025

Mar-2027

Healers Lab Unit II Plot No. 33, H.P.S.I.D.C., Extn., Baddi, Distt-Solan (H.P.)

sample does not comply as per I.P. 2022 with respect to the test for "Dissolution in buffer stage" For Pantoprazole.

CDSCO Labs

RDTL, Guwahati

SEP-2025

41

Ambroxol HCl, Salbutamol Sulphate & Guaiphenesin Liquid

RSP3041

May-2023

Apr-2026

Naxpar Pharma Pvt. Ltd. 182, Village- Gurumajra, Kishanpura, Baddi, Dist- Solan Himachal Pradesh -174101.

sample does not conform to claim as per Manufacturer Specification with respect to the test for "Assay" of Ambroxol Hydrochloride and Salbutamol.

CDSCO Labs

RDTL, Guwahati

SEP-2025

42

Picozide Sodium Picosulfate, Liquid Paraffin & Milk of Magnesia Suspension

PZDS-041

Jul-2025

Jun-2027

Iosis Remedies Pvt. Ltd.Rajpura Road, Village- Khera Nihla Tehsil- Nalagarh, District - Solan, Himachal Pradesh - 174 101, India.

sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Liquid Paraffin

CDSCO Labs

RDTL, Chandigarh

SEP-2025

43

RAXOFEN Ibuprofen and Paracetamol Tablets IP

6563

Apr-2025

Mar-2027

R.P. Biotech Pvt. Ltd. 61, Industrial Focal Point, Batala, District Gurdaspur, Punjab.

sample does not conform to claim as per IP 2022 in respect to the Test of Dissolution of Paracetamol, Dissolution of Ibuprofen

CDSCO Labs

RDTL, Chandigarh

SEP-2025

44

PODORAM Cefpodoxime Tablets I.P. 200 mg

6492

Mar-2025

Feb-2027

R.P. Biotech Pvt. Ltd., 61, Industrial Focal Point, Batala, District Gurdaspur, Punjab.

sample does not conform to claim as per IP 2022 in respect to the Test of Dissolution and Assay of Cefpodoxime Proxetil calculated as Anhydrous Cefpodoxime

CDSCO Labs

RDTL, Chandigarh

SEP-2025

45

Cyproheptadine Tablets IP 4 mg

6489

Mar-2025

Feb-2027

R.P. Biotech Pvt. Ltd. 61, Industrial Focal Point, Batala, District Gurdaspur, Punjab.

sample does not conform to claim as per IP 2022 in respect to the Assay of Cyproheptadine Hydrochloride

CDSCO Labs

RDTL, Chandigarh

SEP-2025

46

Amoxycillin Trihydrate Dispersible Tablets IP 250 mg

DL-58

Oct-2024

Sep-2026

SVR Healthcare , Barotiwala,Paonta Sahib, Distt. Sirmour (H.P)-173025

Disintegration test, Uniformity of dispersion and Assay

CDSCO Labs

RDTL, Chandigarh

SEP-2025

47

Cefixime Tablets IP 200 mg

DL-134

Oct-2024

Nov-2026

SVR Healthcare , Barotiwala,Paonta Sahib, Distt. Sirmour (H.P)-173025

Assay

CDSCO Labs

RDTL, Chandigarh

SEP-2025

48

Loperamide Hydrochloride Capsules IP 2 mg

7645

Mar-2025

Feb-2027

R.P. Biotech Pvt. Ltd. 61, Industrial Focal Point, Batala, District Gurdaspur, Punjab.

sample does not conform to claim as per IP 2022 in respect to the Test of Dissolution

CDSCO Labs

RDTL, Chandigarh

SEP-2025

49

PANZOLE Pantoprazole Sodium Tablets I.P.

6735

Jun-2025

May-2027

R.P. Biotech Pvt. Ltd. 61, Industrial Focal Point, Batala, District Gurdaspur, Punjab.

sample does not conform to claim as per IP 2022 and Addendum 2024 in respect to the Test of Dissolution (Buffer Stage)

CDSCO Labs

RDTL, Chandigarh

SEP-2025

50

AMLOCARE-AT Amlodipine and Atenolol Tablets IP

6717

Jun-2025

May-2027

R.P. Biotech Pvt. Ltd. 61, Industrial Focal Point, Batala, District Gurdaspur, Punjab.

sample does not conform to claim as per IP 2022 in respect to the Assay of Amlodipine Besylate Calculated As Amlodipine, Atenolol

CDSCO Labs

RDTL, Chandigarh

SEP-2025

51

Clopidogrel & Aspirin Tablets I.P. (75 mg & 75 mg)

Z24-338

May-2024

Apr-2026

Zee Laboratories Ltd. Behind 47, Industrial Area, Paonta Sahib-173025

sample does not conform to I.P with respect to the test for Dissolution (Clopidogrel).

CDSCO Labs

CDTL, Indore

SEP-2025

52

Clopidogrel and Aspirin Tablets IP .

GT241285

Jul-2024

Jun-2026

Theon Pharmaceuticals Ltd. Vill. Saini Majra, Tehsil Nalagarh, Distt. Solan (H.P.) 174 101.

sample is not of standard quality with respect to the reason stated under 'Description'.

CDSCO Labs

CDTL, Indore

SEP-2025

53

Clopidogrel & Aspirin Tablets IP (75mg/75mg)

GT241286

Jul-2024

Jun-2026

Theon Pharmaceuticals Ltd. Vill. Saini Majra, Tehsil Nalagarh, Distt. Solan (H.P.) 174 101.

sample is not of standard quality with respect to the reason stated under 'Description'.

CDSCO Labs

CDTL, Indore

SEP-2025

54

CLOPIMEN-75 Clopidogrel Tablets IP 75 mg

T-2405321

May-2024

Apr-2026

Rivpra Formulation Pvt. Ltd. Plot No.8, Sector-6A, I.I.E. SIDCUL, Haridwar-249 403 (U.K.)

sample received does not conform to I.P. 2022 for the reason stated under description and with respect to the tests for Related substances" and "Assay.

CDSCO Labs

CDTL, Mumbai

SEP-2025

55

NS-CAP Sodium Chloride Injection IP 0.9% w/v

LV50333

Mar-2025

Feb-2027

Captab Biotec Unit-II, Plot No.125, E.P.I.P. Road, Mauja, Jharmajri, Baddi, Distt. Solan (H.P.) - 173 205

sample does not conform to I.P. 2022 with respect to the test for "Bacterial endotoxins"

CDSCO Labs

CDTL, Mumbai

SEP-2025

56

TRIMESOL MR 35 Tablets Trimetazidine Hydrochloride Modified Release Tablets

TSF-C2721A

Oct-2024

Sep-2026

Spen Formulations Pvt. Ltd., Plot No.-123, Industrial Area, Mehatpur, Distt. UNA-174315 (H.P.)

sample does not conforms to Manufacturer's specification with respect to the test for "Dissolution".

CDSCO Labs

CDTL, Mumbai

SEP-2025

57

Multiple Electrolytes And Dextrose Injection Type I IP,

P4BY04

Feb-2025

Jan-2028

Swaroop Pharmaceuticals Pvt. Ltd. A-10, Tala Nagari Industrial Area, Aligarh 202001, Uttar Pradesh

sample received does not conform to I.P. 2022 with respect to the test for Assay of magnesium and phosphate

CDSCO Labs

CDTL, Mumbai

SEP-2025

58

Omeprazole

CT51891

Dec-2024

Nov-2026

Cosmas Pharmacis Ltd.Buranwala Road,Village Kotla ,Barotiwala Road,Village Kotla P.O,Barotiwala Solan(H.P)-174103.

Dissolution

State Lab

DTL,Dalgate Srinagar Kashmir( J&K)

SEP-2025

59

Telmisartan Tablets

PGT24720

Sep-2024

Aug-2026

Affy Parenterals (WHO-cGMP/ISO 9001:2015 Certified Co.) Vill Gullerwala. P.O Baddi, Distt.Solan-173205.(HP)

Dissolution

State Lab

DTL,Dalgate Srinagar Kashmir( J&K)

SEP-2025

60

Ondansetron Injection IP

PGY25248

Apr-2025

Mar-2027

Affy Parenterals (WHO-cGMP/ISO 9001:2015 Certified Co.) Vill Gullerwala. P.O Baddi, Distt.Solan-173205.(HP)

pH.

State Lab

DTL,Dalgate Srinagar Kashmir(J&K)

SEP-2025

61

Telmisartan Tablets IP

PGT24669

Sep-2024

Aug-2026

Affy Parenterals Vill.: Gullerwala, P.O. Baddi, Distt. Solan ? 173205 (HP)

Description

State Lab

MDTL Kathua ( J&K)

SEP-2025

62

Metronidazole Tablets IP 400 mg

B250104

Jan-2025

Dec-2026

Bochem Healthcare Pvt. Ltd . 83-84, Industrial Area, Dewas Road, Nagziri, Ujjain 456010 (M.P.) India

Description

State Lab

MDTL Kathua ( J&K)

SEP-2025

63

Telmisartan Tablets IP

PGT241031

Dec-2024

Nov-2026

Affy Parenterals, Vill. Gullerwala, P.O. Baddi, Distt. Solan ? 173205 (H.P.)

Description and Dissolution

State Lab

MDTL Kathua ( J&K)

SEP-2025

64

Telmisartan Tablets I.P. (20 mg)

TFI24009AL

Aug-2024

Jul-2026

Hindustan Laboratories Ltd., Plot No. 5-9, Survey No. 38/2, Aliyali Palghar (W), Dist ? Palghar 401404 (M.S.).

Description

State Lab

MDTL Kathua ( J&K)

SEP-2025

65

Albendazole Tablets IP

PGT25480

Jun-2025

May-2028

Affy Parenterals (WHO- cGMP/ISO 9001:2015 Certified Co.) Vill. Gullerwala, P.O. Baddi, Distt. Solan- 173 205 (HP)

Dissolution

State Lab

SDTL Raipur Chhattisgarh

SEP-2025

66

Albendazole Tablets IP

PGT25450

Jun-2025

May-2028

Affy Parenterals (WHO- cGMP/ISO 9001:2015 Certified Co.) Vill. Gullerwala, P.O. Baddi, Distt. Solan- 173 205 (HP)

Dissolution

State Lab

SDTL Raipur Chhattisgarh

SEP-2025

67

Albendazole Tablets IP

PGT25229

Mar-2025

Feb-2028

Affy Parenterals (WHO- cGMP/ISO 9001:2015 Certified Co.) Vill. Gullerwala, P.O. Baddi, Distt. Solan- 173 205 (HP)

Dissolution

State Lab

SDTL Raipur Chhattisgarh

SEP-2025

68

Amoxycillin Tablets IP"

CT2193

Nov-2024

Apr-2026

TPD Associates At: No 336, IV Phase, Peenya Industrial Area Bengaluru Karnataka-560 058

Assay

State Lab

SDTL Raipur Chhattisgarh

SEP-2025

69

Albendazole Tablets IP Legal Sample )

PGT25229

Mar-2025

Feb-2028

Affy Parenterals (WHO- cGMP/ISO 9001:2015 Certified Co.) Vill. Gullerwala, P.O. Baddi, Distt. Solan- 173 205 (HP)

Dissolution

State Lab

SDTL Raipur Chhattisgarh

SEP-2025

70

Paracetamol Tablets IP- 500

CP30813

Aug-2023

Jul-2026

HSN Biotech Plot No 40 Sector 6A, SIDCUL Haridwar-249 403, (Uttarakhand)

Assay

State Lab

SDTL Raipur Chhattisgarh

SEP-2025

71

Aceclofenac & Paracetamol

ET24260

Nov-2024

Oct-2027

Edkem Pharmaceuticals Ltd., ( A WHO-GMP CERTIFIED COMPANY) M9 M12 Gallop Industrial Park II Chancharvadi Vasna Bavla Changodar Highway Ahmedabad- 382210

Misbranded

State Lab

SDTL Raipur Chhattisgarh

SEP-2025

72

Dieclofenac Potassium & Paracetmol

T082441

Aug-2024

Jul-2027

Swefn Pharmaceuticals Pvt. Ltd., 7 Sopan Kesar Industrial Hub, Vill- Moraiya Distt- Ahmedabad- 382213

Assay

State Lab

SDTL Raipur Chhattisgarh

SEP-2025

73

Clobetasol Propionate Neomycin Sulphate and Miconazole Nitrate Cream

18241408A

Jul-2024

Jun-2026

Macleods Pharmaceuticals Ltd.Khasra No 21,22,66,67 & 68 Aho- Yangtam Namchepung P.O. Ranipool, Sikkim 737135

Spourios

State Lab

SDTL Raipur Chhattisgarh

SEP-2025

74

Ivabradine Tablets 5 mg

HTL0028

Feb-2025

Jan-2027

Hetero Labs Ltd., (Unit II) Village: Kalyanpur, Chakkan Road, Tehsil: Baddi, Distt. Solan, Himachal Pradesh. 173205

Dissolution

State Lab

Directorate of Food & Drugs, Bambolim, Goa.

SEP-2025

75

Tramadol Hydrochloride Sustained Release Tablets I.P. 100mg -

MNT27015

Jan-2025

Dec-2026

Medicross Laboratories Pvt. Ltd., Plot No. 119, HPSIDC, Industrial Area, Baddi, Dist. Solan. (H.P.)

Spurious identification, Dissolution and Assay.

State Lab

Directorate of Food & Drugs, Bambolim, Goa.

SEP-2025

76

Sodium Bicarbonate Tablets USP 300mg

AT2502

May-2025

Apr-2028

Alves Healthcare Pvt Ltd. Nangal Uperla, Swarghat Road, Nalagarh, Dist. Solan (H.P.) India - 174101.

Assay

State Lab

Food & Drugs Laboratory, Bambolim, Goa.

SEP-2025

77

Alpha Lipoic Acid IP 100 mg,Pyridoxine Hydrochloride IP 3 mg,Methylcobalamin IP 1500 mcg,Folic Acid IP 1.5mg & Vitamin D3 IP 1000 I.U. Tablets)

FT240594B

Aug-2024

Jan-2026

Foregen Healthcare Ltd.Plot No. 104-105 DIC Industrial Area Baddi Distt. Solan H.P.

Disintegration

State Lab

DTL, BADDI H.P.

SEP-2025

78

Paracetamol

HPC332

Dec-2024

May-2026

Hema Pharmaceuticals plot no 18 & 21 Phase III Ind Area Sansarpur Terrice , Distt Kangra HP 176501

Assay

State Lab

DTL, BADDI H.P.

SEP-2025

79

Ambroxol, Levosalbutamol Guaiphenesin Syrup

SML-2465

Mar-2024

Feb-2026

Saitech Medicare Pvt. Ltd. Village Kheri, Trilokpur Road, Kala- Amb District Sirmour, H.P-173030

Assay

State Lab

DTL/Baddi

SEP-2025

80

Paracetamol Tablets IP 650 mg

TEM25002AL

Mar-2025

Feb-2025

Hindustan Laboratories Ltd. Plot No. 5-9, survey No. 38/2, Aliyali, Palghar (W) Distt. Palghar 401404 (M.S.).

Dissolution

State Lab

DTL/Baddi

SEP-2025

81

Iron Sucrose Injection IP

A23412F

Oct-2023

Sep-2025

Pace Biotech , Surajpur, Paonta Sahib, Distt Sirmour HP

Misbranded

State Lab

DTL Baddi

SEP-2025

82

Ventrozole-1500

EMVB-24222

Dec-2024

Nov-2026

Events Cotporation, Unit-II, Kala Amb, Tehsil Nahan, Distt. Sirmour HP

NA

State Lab

DTL Baddi

SEP-2025

83

Zinc Sulphate Dispersible Tablet IP 20 mg

MT10104

Jun-2024

May-2026

McW Healthcare(P) Ltd 286,287-A, 287-B ,Sector -E Industrial Area Sanwer Raod Indore (M.P)

Disintergration and Uniformity of Dispersion

State Lab

DTL, Baddi (H.P)

SEP-2025

84

Paracetamol ,Phenlyephrine HCL & Chlorpheniramine Maleate Suspension

GS-4024

Mar-2025

Feb-2027

Gag Pharmaceuticals VPO Mubarkpur Shaikhan Jalandhar

Assay

State Lab

DTL, Baddi (H.P)

SEP-2025

85

Paracetamol, Phenylephrine Hcl, Caffeine & Diphenhydramine Hcl Tablets

YLT25006

Jan-2025

Dec-2026

YL Pharma, Plot No.9H(1), Village-Katha, Baddi, District Solan-173205(HP)

Identification & Assay

State Lab

DTL ,Baddi, HP

SEP-2025

86

Fillace-P

MMT-12846

Apr-2025

Mar-2027

Near Railway Crossing, Chambaghat, Solan, Distt- Solan,(H.P)

Assay

State Lab

DTL, Baddi, Dist-Solan(H.P)

SEP-2025

87

Alenvox500

PNT4-1018D

Nov-2024

Oct-2026

Vill-Dhana(Bagh Bania), Teh- Nalagarh,Distt- Solan(H.P)

Identification & Assay

State Lab

DTL, Baddi, Dist-Solan(H.P)

SEP-2025

88

Noscapine Cough Syrup

LG24-34

Jul-2025

Jun-2025

Om Biometic Pvt.Ltd Plot No.68,9,82,&83, Sector -6A,IIE. Sidcul,Haridwar-249403 Uttarkhand

Assay

State Lab

DTL, Meghalaya State

SEP-2025

89

Ferrous Sulphate &Folic Acid

40791

Jun-2025

Nov-2025

Zenith Drugs Ltd (WHO-GMP Cert.co.)72/5,72/3,72/4,74/1/1,75/1/1, Muradpura Orangpura),Dhar Road Near Kalaria,Indore-453001,M.P (India)

Assay

State Lab

DTL, Meghalaya State

SEP-2025

90

Aspirin Tablets IP

G/25/1739

Apr-2025

Mar-2027

Modi Antibiotic, Plot No. 28, G.I.D.C, Odhav Ahmedabad (Gujarat) Ahmedabad

Description and related substances.

State Lab

FDAL, Maharashtra

SEP-2025

91

Azithromycin Tablets IP

TG23074A

Mar-2024

Feb-2026

Cure Health Pharmaceuticals Pvt Ltd. Village Raipur P.O Deothi, Tehsil and District Solan-173211

Description

State Lab

FDAL, Maharashtra

SEP-2025

92

Paracetamol Tablets IP 500 mg

CLR23725

Mar-2024

Feb-2026

Cureza Healthcare Pvt Ltd. Cureza Healthcare Ltd. A.B. Road, Girwai, 474001

Description and Dissolutioin Test.

State Lab

FDAL, Maharashtra

SEP-2025

93

Oxyclozanide, Levamisole Hydrochloride & Silymarin Bolus Vet

CPT2504266

Apr-2025

Mar-2027

CURE QUICK PHARMACEUTICALS 20-21/3, HSIIDC, KAMAL-132001 (HARYANA)

Assay

State Lab

SDTL, Punjab

SEP-2025

94

Primidone Tablets

AR250209

Feb-2025

Jan-2027

Alteus Remedies Pvt. Ltd., EPIP, Kartholi, SIDCO Industrial Lane, Bari Brahmana Distt. Samba-18113

Misbranded

State Lab

SDTL, Punjab

SEP-2025

95

Miconazole Nitrate Cream IP 2% w/w

MZP-2502

Aug-2025

Jul-2027

Apple Formulations Pvt, Ltd, Plot No.208, Kishanpur, Roorkee-247667 (U.K)

Assay

State Lab

SDTL, Punjab

SEP-2025

96

ZINC SULPHATE ORAL SOLUTION IP

2508181

Aug-2025

Jul-2027

Saar Biotech Pvt. Ltd., VPO-Bhud, Tehsil-Baddi Distt. Solan (H.P.) 173205

Misbranded

State Lab

SDTL, Punjab

SEP-2025

97

ZINC SULPHATE ORAL Solution IP

2508180

Aug-2025

Jul-2027

Saar Biotech Pvt. Ltd., VPO-Bhud, Tehsil-Baddi Distt. Solan (H.P.) 173205

Misbranded

State Lab

SDTL, Punjab

SEP-2025

98

CEFPODOXIME PROXETIL DISPERSIBLE Tablets

UCT-25327H

Aug-2025

Jul-2027

Ultra Drugs Pvt.Ltd., Plot No: 1315-1318, VPO Manpura, Baddi-Nalagarh Road, Distt. Solan (H.P.) 174101

Uniformity of Dispersion.

State Lab

SDTL, Punjab

SEP-2025

99

Zinc Sulphate Oral Solution IP

2508179

Aug-2025

Jul-2027

Saar Biotech Pvt. Ltd., VPO-Bhud, Tehsil-Baddi Distt. Solan (H.P.) 173205

Misbranded

State Lab

SDTL, Punjab

SEP-2025

100

Ondansetron Oral Solution IP

K3ADY003

Apr-2025

Mar-2027

Copmed Pharmaceuticals Pvt.Ltd, Unit-1, Plot NO. 4A&B, Gondpur Industrial Area, Paonta Sahib, Distt. Sirmour - 173205 (HP). Himachal Pradesh.

pH

State Lab

DCL, Telangana

SEP-2025

S.No

Name of Product

Batch No

Manufacturing Date

Expiry Date

Manufactured By

NSQ Result

Reporting Source

Reporting by Lab/State

Reporting Month & Year

101

Amoxycillin & Potassium Clavulanate Tablets IP

DBT-2508A

Nov-2025

Apr-2026

Dr. Edwin Medilabs Pvt.Ltd,Plot No. B-29, Industrial area, Focal Point, chanalon, Kurali, SAS Nagar - 140103 (Pb) Punjab.

Asay and Dissolution

State Lab

DCL, Telangana

SEP-2025

102

Diethyl carbamazine citrate Tablets IP 100 mg

B221194

Dec-2025

Nov-2025

Biochem Healthcare Pvt.Ltd, 83, 84, Industraial Area, Dewas Road Nagziri, Ujjain, 456010, Madhya Pradesh,

Description

State Lab

DCL, Telangana

SEP-2025

103

Calcium Carbonate Tablets I.P.

RCBT-003

May-2024

Apr-2026

Revat Laboratories Pvt.Ltd, 12-321, OPP: I.D.A, Kurnool Road, Pernamitta, Ongole - 523 002 Andhra Pradesh.

Description

State Lab

DCL, Telangana

SEP-2025

104

Cefpodoxime Proxetil & Potassium Clavulanate oral suspension

HSBD-24107

Oct-2024

Mar-2026

UPKAR PHARMACEUTIALS, 101, Industrial area, Gondpur, Paontashaib, Dist Sirmour H.P. 173025. Himachal Pradesh.

Assay

State Lab

DCL, Telangana

SEP-2025

105

Pantoprazole tablets IP

NMPN-2403

Oct-2024

Sep-2026

Konis Pharmaceuticals Pvt.Ltd, Jagriti Sadan, Subathu Road, Solan, - 173 212, Himachal Pradesh.

Dissolution

State Lab

DCL, Telangana

SEP-2025

106

Rabeprazole Gastro-resistant Tablets IP 20 mg,

RABP45003

Oct-2024

Sep-2026

Sunrise International labs Ltd, Plot No. 100, Lane - 5, Sector - II, Phase-II, IDA cherlapally, Hydrabad - 500051 Telangana.

Asay & Dissolution

State Lab

DCL, Telangana

SEP-2025

107

Cetirizine Hydrochloride Tablets, I.P.

LPT2425300

Feb-2025

Jan-2027

Lannett Pharmaceuticals Hydrochloride Pvt.Ltd, Plot no. D-8c, & D-8D, Sigaddi Growth Center, Sidcul, Industrial Area, Kotdwar - 246 149 (UK), Uttarakhand.

Description

State Lab

DCL, Telangana

SEP-2025

108

Aceclofenac & Paracetamol Tablets

MHT25-013

Jan-2025

Dec-2026

Mahys Pharmaceuticals survey No. 519-C3A2, BK Puram Road, Satuluru - 522549, AP. Andhra Pradesh.

Misbranded

State Lab

DCL, Telangana

SEP-2025

109

Aceclofenac & Paracetamol Tablets,

MHT25-004

Jan-2025

Dec-2026

Mfg By: Mahys Pharmaceuticals survey No. 519-C3A2, BK Puram Road, Satuluru - 522549, AP. Andhra Pradesh. Mrkt: Zenque Health care, Survey No. 519-c3a2, BK puram Road, Satuluru - 522 549, A.P.

Misbranded

State Lab

DCL, Telangana

SEP-2025

110

Diclofenac Sodium and Paracetamol Tablets IP

TT240758

Jun-2024

May-2026

Trugen Pharmaceuticals Pvt. Ltd.,Vill. Tejjupur,Near Chodiala Rly. Station, Roorkee, Distt. Haridwar, Uttarakhand-247661

Dissolution Of Paracetamol

State Lab

Government of NCT of Delhi

SEP-2025

111

Diclofenac Sodium and Paracetamol Tablets IP

I405175

Oct-2024

Sep-2026

Zydus Healthcare Ltd.,(Unit II) 967 (P),968 (P), 970 (P), Duga Circle, Kamarey Bhasmay, Kumrek, Sikkim-737132

Assay & Dissolution

State Lab

Government of NCT of Delhi

SEP-2025

112

Amikacin Sulphate Injection IP 500mg/2ml

24AM19

Dec-2024

Nov-2026

SAI Parenterals Limited D1 & D4, Survey No.280,Phase-V, IDA,Jeedimetla, Hyderabad, 500055, TS, India

Sterility', 'Particulate Matter' and "Description".

CDSCO Labs

CDL, Kolkata

SEP-2025

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