46 Drug Batches Fail CDSCO Quality Test In July, Details
New Delhi: The Central Drugs Standard Control Organization (CDSCO) has declared 46 batches of medicines as "Not of Standard Quality" (NSQ) after drug samples tested by its regional and central laboratories in July 2025 failed to meet required pharmacopeial standards.
The flagged medicines include widely prescribed formulations such as antibiotics, cardiac drugs, gastrointestinal medicines, hormonal injections, and pain relief products.
These include Azithromycin Tablets IP (Aziventis-500) manufactured by Gnosis Pharmaceuticals, Heparin Injection IP 1000 IU/ml (Flagorin) manufactured by Divine Laboratories, Amikacin Sulphate Injection manufactured by SAI Parenterals, Amoxycillin and Potassium Clavulanate Tablets I.P. 625 mg manufactured by Hindustan Antibiotics, Dexamethasone Tablets IP 4mg (Dexatore-4) manufactured by United Bioceuticals, and others.
According to the alert, the samples failed various quality parameters, including assay content, dissolution, sterility, uniformity, and presence of impurities.
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The tests were conducted at CDSCO’s central and regional drug testing laboratories located in Kolkata, Mumbai, Chennai, Hyderabad, and Chandigarh. Each lab confirmed that multiple batches of medicines did not comply with the Indian Pharmacopoeia standards.
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 JULY 2025
S.No | Medicine Name | Batch No. | Mfg Date | Exp Date | Manufacturer | Reason for Failure | Lab | Report Date | Reporting Year and month |
1 | Adrenaline Bitartrate Injection I.P. (Adrebest) | GN-285 | Jul-2024 | Jun-2025 | Coax Bioremedies Pvt. Ltd., Hisar | Particulate matter; Not of standard quality (Description) | CDL, Kolkata | Jul-2025 | JUL-2025 |
2 | Vitamin C Injection + Vitamin B12, Folic Acid, Niacinamide (Eldervit-12) | MVRW25002, MVAR25002 | Jan-2025 | Dec-2026 | Micropure Parenteral Pvt. Ltd., Thane | Particulate matter; Not of standard quality (Description) | CDL, Kolkata | Jul-2025 | JUL-2025 |
3 | Absorbent Cotton Wool IP (To be sterilized before use) | 2079 | Dec-2024 | – | JIND SURGICALS, Haryana | Test of Foreign Fibres | RDTL, Chandigarh | Jul-2025 | JUL-2025 |
4 | Infusion set-NV | KT-093 | Feb-2025 | Jan-2028 | Medivision Healthcare, Ahmedabad | Sterility | RDTL, Guwahati | Jul-2025 | JUL-2025 |
5 | Azithromycin Tablets IP (Aziventis-500) | GT400149 | Apr-2024 | Mar-2026 | Gnosis Pharmaceuticals Pvt. Ltd., Sirmour (HP) | Test for dissolution | CDL, Kolkata | Jul-2025 | JUL-2025 |
6 | Sucralfate & Oxetacaine Oral Suspension(Sucrakars- O Suspension) | RL2412-10 | Dec-2024 | Nov-2026 | Regent Ajanta Biotech, 86-87, Village Makhiyali Dundi, Peerpura Road, Roorkee-247667 (U.K) | Assay of Sucralfate | CDSCO Labs | CDL, Kolkata | JUL-2025 |
7 | Heparin Injection IP 1000 IU/ml (Flagorin) | DP4111 | Mar-2024 | Feb-2027 | Divine Laboratories Pvt. Ltd. Block No. 471 Dabhasa, Tal. Padra, Dist. Vadodara-391440, India. | Assay of Heparin (Anti-factor IIa activity) | CDSCO Labs | CDL, Kolkata | JUL-2025 |
8 | Amoxycillin and Potassium Clavulanate Tablets I.P. 625 mg | BT240754 | Jun-2024 | May-2026 | Hindustan Antibiotics Ltd Village Saini Majra, Tehsil Nalagarh Dist. Solan (H.P.)-174101 | Dissolution of Amoxycillin, Water, Dissolution of Clavulanic Acid and Assay of Potassium Clavulante | CDSCO Labs | CDL, Kolkata | JUL-2025 |
9 | 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, Telangana, India | "Particulate Matter", "Bacterial Endotoxin", "Sterility" and is also not of standard quality for the reason stated under "Description". | CDSCO Labs | CDL, Kolkata | JUL-2025 |
10 | Vitamin C Injection IP and Vitamin B12, Folic Acid and Niacinamide Injection (Eldervit-12 injection) | MVRW25004, MVAR25004 | Jan-2025 | Dec-2026 | Micropure Parenteral Private Limited Plot no-136, Neharoli, Wada, Thane, Maharashtra-421312 | "Particulate Matter" and is also not of standard quality for the reason stated under "Description" | CDSCO Labs | CDL, Kolkata | JUL-2025 |
11 | Dexamethasone Tablets IP 4mg (Dexatore-4) | T242704 | Dec-2024 | Nov-2026 | United Bioceuticals Pvt. Ltd. Plot No. 33 C, Industrial Park-IV, Begumpur, Haridwar-249402, Uttarakhand | Dissolution | CDSCO Labs | CDL, Kolkata | JUL-2025 |
12 | Amoxycillin & Potassium Clavulanate Tablets I.P. (Amoxyclav 625) | MFK0076 | Feb-2024 | Jan-2026 | Medicef Pharma. Plot No. 28, 29 & 48, Phas-I, EPIP, Jharmajri, Baddi, Distt. Solan- 173205 (H.P.), India. | Identification and Assay of Amoxycillin and Clavulanic Acid. | CDSCO Labs | CDL, Kolkata | JUL-2025 |
13 | Meropenem Injection IP 250 mg | MRO-05 | Aug-2024 | Jul-2026 | Agron Remedies Pvt. Ltd.,Agron Remedies Pvt. Ltd. Sarverkhera, Moradabad Road, Kashipur-244713 (Uttarakhand) | Identification and Assay of Meropenem, Clarity of solution, Particulate Matter, Content of sodium and is also not of standard quality for the reason stated under "Description". | CDSCO Labs | CDL, Kolkata | JUL-2025 |
14 | Bupivacaine Hydrochloride In Dextrose Injection USP 4ml | 17B24002 | Mar-2024 | Feb-2026 | Radiant Parenterals Ltd. 242/5 & 6, G.I.D.C. Estate at & Post Waghodia, Dist- Vadodara, Gujarat- 391760 | "Determination of volume of Injection in containers". | CDSCO Labs | CDL, Kolkata | JUL-2025 |
15 | Doxepin Hydrochloride Capsules IP (Doxon 75) | CC23240161 | Feb-2024 | Jan-2026 | CMG Biotech Pvt.Ltd. ( A WHO-GMP Certified Co.),58, Industrial Area, Phase-III, Sansarpur Terrace-176501 (H.P.) | Dissolution and Assay of Doxepin Hydrochloride. | CDSCO Labs | CDL, Kolkata | JUL-2025 |
16 | Cyanocobalamin Injection I.P. 500 mcg/ml (ALPA-B12) | VL5095 | Mar-2025 | Feb-2027 | Alpa Laboratories Ltd 33/2, A.B. Road, Pigdamber-453 446, Indore (M.P.) | Particulate matter and is also not of standard quality for the reason stated under "Description" | CDSCO Labs | CDL, Kolkata | JUL-2025 |
17 | Atropine Sulphate Injection IP | MA23H84 | Aug-2023 | Jul-2025 | Martin & Brown Bio-sciences K. No. 918/419, Malkumajra, Nalagarh Road, Baddi, Distt. Solan (H.P.)-173205 | "Particulate matter" and is also not of standard quality for the reason stated under "Description". | CDSCO Labs | CDL, Kolkata | JUL-2025 |
18 | Vitamin C Injection IP and Vitamin B12, Folic Acid and Niacinamide Injection (Eldervit-12 Injection) | MVAR25005 | Jan-2025 | Dec-2026 | Micropure Parenteral Private Limited Plot no-136, Neharoli, Wada, Thane, Maharashtra-421312 | "Particulate Matter"and is also not of standard quality for the reason stated under "Description". | CDSCO Labs | CDL, Kolkata | JUL-2025 |
19 | Marbromine Solution IP | 10 | Aug-2023 | Jul-2025 | New Lab Industry Ram Nagar Rd, Postal Park, Kurthoul, Patna, Bihar 804453 | Identification and Assay of Marbromine. | CDSCO Labs | CDL, Kolkata | JUL-2025 |
20 | Aminophylline Injection I.P. 10 ml | MA24G125 | Jul-2024 | Jun-2026 | MARTIN & BROWN BIO-SCIENCES PVT. LTD.,K.No. 918/419, Malkumajra, Nalagarh Road, Baddi, Dist.Solan (H.P.)-173205 | "Extractable volume", "Particulate matter"and is also not of standard quality for the reason stated under "Description". | CDSCO Labs | CDL, Kolkata | JUL-2025 |
21 | Cefuroxime Axetil Tablets IP 500mg | T-21544 | Oct-2024 | Sep-2026 | Jackson Laboratories Pvt. Ltd., Plot No. 56 & 61, Industrial Area, Phase III, Sansarpur Terrace, Distt Kangra (H.P.)-176501 | Dissolution of Cefuroxime | CDSCO Labs | RDTL, Guwahati | JUL-2025 |
22 | Telmisartan Tablets IP 40mg (Savtel 40 Tablets) | PT-40586 | Feb-2024 | Jan-2026 | Pharmaroots Healthcare, Khasra No. 411, Village Tipra, P.O. Barotiwala, Tehsil Baddi, Distt. Solan, H.P. | Dissolution of Telmisartan | CDSCO Labs | RDTL, Guwahati | JUL-2025 |
23 | Telmisartan Tablets IP 40mg | TLL-507 | Jan-2025 | Dec-2026 | Healers Lab Unit II, Plot No. 33, H.P.S.I.D.C., Extn.,Baddi, Distt-Solan (H.P) | Dissolution of Telmisartan | CDSCO Labs | RDTL, Guwahati | JUL-2025 |
24 | Telmisartan Tablets IP 40 mg | TLL-505 | Jan-2025 | Dec-2026 | Healers Lab Unit II, Plot No. 33, H.P.S.I.D.C., Extn.,Baddi, Distt-Solan (H.P) | Dissolution of Telmisartan | CDSCO Labs | RDTL, Guwahati | JUL-2025 |
25 | Noradrenaline Bitartrate Injection IP | SAI-24037 | Mar-2024 | Feb-2026 | Sunvet Health Care, Vill. Shambhuwala, Nahan, Paonta Road, Distt. Sirmour (H.P.) 173001 | "Particulate Matter" and is also not of standard quality for the reason stated under " Description". | CDSCO Labs | CDL, Kolkata | JUL-2025 |
26 | Pantoprazole Gastro-Resistant Tablets IP (Pantoziv 40) | GD24157 | Sep-2024 | Aug-2026 | M/s. Skymap Pharmaceuticals Pvt. Ltd., B3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee - 247 667 | Dissolution in Buffer Stage for Pantoprazole | CDSCO Labs | RDTL, Guwahati | JUL-2025 |
27 | Albendazole Tablets IP 400 mg. (Macbi-400) | SPT241854 | Sep-2024 | Aug-2026 | SALUS PHARMACEUTICALS, 480/211, Harraipur, PO Gurumajra, Teh. Baddi, Distt. Solan (H.P.) 173205 | Dissolution of Albendazole | CDSCO Labs | RDTL, Guwahati | JUL-2025 |
28 | Cefuroxime Axetil Tablets IP 500mg | T-21172 | Jul-2024 | Jun-2026 | Jackson Laboratories Pvt. Ltd., Plot No. 56 & 61, Industrial Area, Phase III, Sansarpur Terrace, Distt Kangra (H.P.)-176501. | Dissolution of Cefuroxime | CDSCO Labs | RDTL, Guwahati | JUL-2025 |
29 | Methylprednisolone Tablets IP 8 mg (ROMPRED-8 Tablets) | RP-T867/A | Apr-2025 | Mar-2027 | Roma Pharma Pvt. Ltd. Unit-II Village- Nagali, P.O. Barog, Tehsil & Distt. Solan (H.P.)- 173211 | Test of Dissolution and Assay of Methylprednisolone | CDSCO Labs | RDTL, Chandigarh | JUL-2025 |
30 | Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride & Chlorpheniramine Maleate Syrup (BRONCHITY-DX) | MFL-250501 | May-2025 | Apr-2027 | Manfriday Lifesciences Khewat no. 17/10, Khata No. 27, Rect & Killa No. 27/6/2/2(2-8), Vill. Liwaspur, Sonipat, Haryana | Assay of Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride | CDSCO Labs | RDTL, Chandigarh | JUL-2025 |
31 | Fexofenadine Hydrochloride tablets 120mg (Fexomon-120.) | MT2503039 | Mar-2025 | Feb-2027 | MONIQUE PHARMACEUTICALS PVT. LTD.PLOT NO. 676, SECTOR-69, IMT, FARIDABAD, HARYANA-121004 | Test of Dissolution (at 10 min), Dissolution (at 30 min) | CDSCO Labs | RDTL, Chandigarh | JUL-2025 |
32 | Dicyclomine HCl, Mefenamic Acid and Paracetamol Tablets (MEFEN-SPAS TABLETS) | 10769 | Jan-2025 | Dec-2026 | Oyster Labs Limited 81-82, Industrial Estate, Ambala Cantt-133006 | Assay of Mefenamic Acid, Dicyclomine Hydrochloride | CDSCO Labs | RDTL, Chandigarh | JUL-2025 |
33 | Ibuprofen and Paracetamol Tablets IP (400mg/325mg), | IPPT-1018 | May-2025 | Apr-2027 | WINGS BIOTECH LLP 43 & 44, HPSIDC, Ind. Area, Baddi - 173 205 (H.P.) | Test of Uniformity of weight | CDSCO Labs | RDTL, Chandigarh | JUL-2025 |
34 | Diclofenac Potassium, Paracetamol & Serratiopeptidase Tablets (Dainac-SP Tablets) | RP-T878/A | May-2025 | Apr-2027 | Roma Pharma Pvt. Ltd. Unit-II Village- Nagali, P.O. Barog, Tehsil & Distt. Solan (H.P.)- 173211 | Uniformity of weight Assay of Serratiopeptidase | CDSCO Labs | RDTL, Chandigarh | JUL-2025 |
35 | Paroxetine Hydrochloride Prolonged Release Tablets IP 25mg (Pexitalk CR-25 Tablets) | MFT-250501 | May-2025 | Apr-2027 | Manfriday Lifesciences Khewat no. 17/10, Khata No. 27, Rect & Killa No. 27/6/2/2(2-8), Vill. Liwaspur, Sonipat, Haryana | Assay of Paroxetine Hydrochloride Hemihydrate calculated as Paroxetine | CDSCO Labs | RDTL, Chandigarh | JUL-2025 |
36 | Telmisartan Tablets IP(Tel-40) | KR-241126 | Dec-2024 | Nov-2026 | Park Pharmaceuticals 272, Indl. Area, Phase-II, Panchkula- 134113 | Test of Dissolution | CDSCO Labs | RDTL, Chandigarh | JUL-2025 |
37 | Absorbent Cotton Wool IP To be Sterilized before use | 2096 | Jan-2025 | JIND SURGICALS 24-27, HSIIDC Industrial Area, New Hansi Road,Jind-126102 (Haryana) | Test of Foreign Fibres, Sinking time | CDSCO Labs | RDTL, Chandigarh | JUL-2025 | |
38 | Calcium and Vitamin D3 Tablets I.P. | 15702724 | Jan-2024 | Jan-2026 | KARNATAKA ANTIBIOTICS AND PHARMACEUTICALS LIMITED (A Govt. Of India Enterprise) Plot No. 14, II Phase, Peenya, Bengaluru - 560 058. | Dissolution of Calcium | CDSCO Labs | CDTL, Mumbai | JUL-2025 |
39 | Telmisartan Tablets IP 40 mg | TLL-505 | Jan-2025 | Dec-2026 | Healers Lab Unit II, Plot No. 33, H.P.S.I.D.C., Extn.,Baddi, Distt-Solan (H.P) | Dissolution of Telmisartan | CDSCO Labs | RDTL, Guwahati | JUL-2025 |
40 | Ursodeoxycholic Acid Tablets IP | MDT-3717 | Jan-2025 | Dec-2026 | Mayasha Lifesciences H.B. 86, Village-Bhatian Nalagarh, Distt.-Solan (H.P.) 174101 | Dissolution and Assay. | CDSCO Labs | CDTL, Mumbai | JUL-2025 |
41 | Calcium with VItamin D3 Tablets I.P. (Ninecal-500) | C25T005D | Apr-2025 | Sep-2026 | Cartel Laboratories Plot.NO. 10/A And 11/A, Chengicherla, Medchal-Malkajjgiri Dist., Hyderabad-92 | Dissolution For Calcium Carbonate Equivalent To Elemental Calcium (S1, S2, S3 LEVELS)And Assay For Calcium Carbonate Equivalent To Elemental Calcium Only | CDSCO Labs | CDTL, Hyderabad | JUL-2025 |
42 | Calcium with VItamin D3 Tablets I.P. (Calcm-D3) | GT-1241 | May-2025 | Apr-2027 | Vee Laboratories, Village-Kalier, Subathu, Road-Saproon (Post Office) Solan-173211, Himachal Pradesh | Assay of Vitamin D3 Content Only. | CDSCO Labs | CDTL, Hyderabad | JUL-2025 |
43 | CHLORTHALIDONE TABLETS IP 12.5MG (Ifyclodon -12.5 tablets) | T-241169 | Nov-2024 | Oct-2026 | Moon Marks Pharmaceuticals. Plot No- 01, IND, Raja Ka Baghteh. Nurpur, Dist- Kangra (H.P.). | Dissolution | CDSCO Labs | CDTL, Hyderabad | JUL-2025 |
44 | Calcium with VItamin D3 Tablets I.P. (Calcm-D3) | GT -1240 | May-2025 | Apr-2027 | Vee Laboratories, Village-Kalier, Subathu, Road-Saproon (Post Office) Solan-173211, Himachal Pradesh | Assay of Vitamin D3 Content Only. | CDSCO Labs | CDTL, Hyderabad | JUL-2025 |
45 | Valsartan Tablets IP | CT24250295 | May-2024 | Apr-2026 | CMG BIOTECH PVT. LTD. (Unit-II) Plot No. 58, Phase III, Industrial Area, Sansarpur Terrace HP- 176501 | Dissolution | CDSCO Labs | CDTL, Indore | JUL-2025 |
46 | Ramipril Tablets IP 5mg | NHD24605A | Dec-2024 | Nov-2026 | Nest Healthcare Private Limited Plot No.: 300, G.I.D.C., Odhav, Ahmedabad -382415 (Guj.), India | Assay of Ramipril. | CDSCO Labs | CDTL, Indore | JUL-2025 |
