84 Formulations declared Not of Standard Quality as per data provided by states: CDSCO Drug Alert
New Delhi: In line with the 'Not of Standard Quality' data provided by states, the apex drug regulatory body, the Central Drug Standard Control Organisation (CDSCO), in its latest drug safety alert, has flagged 84 medicine batches for failing to qualify for a random sample test for December 2024.
The list of drugs declared not of standard quality includes Cefpodoxime Tablets IP 200 mg (Jan Aushadhi) manufactured by Bharat Parenterals, CEFIXIME AND LACTIC ACID BACILLUS TABLETS (CFI200) manufactured by Swiss Biotech Parentrals, Pantacea 40 Tablets and Pantoprazole Gastro Resistant Tablets IP 40 mg manufactured by Windlas Biotech, Metoprolol Succinate Prolonged Release Tablets IP manufactured by Unicure India, Losartan Potassium Tablets IP 50 mg manufactured by Hindusthan Antibiotics, Ondansetron Injection IP-2ml manufactured by Skymap Pharamceuticals and others.
Furthermore, the list includes Gabacure Gel and Snikuf 4 manufactured by Akums Drugs and Pharmaceuticals, CIPRODAC 500 (Ciprofloxacin Tablets IP 500mg) manufactured by Cadila Pharmaceuticals, METFORMIN HYDROCHLORIDE TABLETS IP (OKAMET500) manufactured by Cipla.
Many factors contributed to the drug samples' failure in the test, such as non-compliance with the IP requirements for the particular drug, failure of the dissolution test, pH, and some assays of the drug test, among others.
In addition to the above, the alert mentioned that the Not of Standard Quality (NSQ) data was received as per Format and in EXCEL SHEET from State Drugs Licensing Authorities of Jammu Kashmir, Tamil Nadu, Himachal Pradesh, Puducherry, Telangana, Thiruvananthapuram (Kerala), Tripura, Ladakh, Karnataka.
Further, it added that NSQ data was received from West Bengal, Goa, as NIL. However, data was not received as per format in Excel Sheet from Assam (PDF Format), Rajasthan (PDF Format), Jharkhand (PDF Format), and Mizoram (PDF Format) for the Month of December 2024 as per DCG(I) Circular dated 09.02.2024.
In addition, the alert stated that State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Bihar, Chhattisgarh, Gujarat, Haryana, Manipur, Meghalaya, Nagaland, Odisha, Punjab, Sikkim, Delhi, Uttarakhand, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the Month of December, 2024 as per DCG(I) Circular dated 09.02.2024.
NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF DECEMBER– 2024
B. State Laboratories | |||||||
S.No | Product/Drug Name | Batch No. | Manufact uring Date | Expiry Date | Manufactured By | NSQ Result | Reported by State Laboratory |
1. | Divalproex Extended Release Tablets IP (JKMSCL Hospital Supply not for sale) | 2406031 | 06/2024 | 05/2026 | Biodeal Pharmaceuticals Ltd Vill Saini MajraNalagarhRopar Road , Nalagarh - 174101 , Distt. Solan (H.P) India | Uniformity of Weights | DTL Srinagar (J&K) & MDTL Kathua (J&K) |
2. | Divalproex Extended Release Tablets IP (JKMSCL Hospital Supply not for sale) | 2407185 | 07/2024 | 06/2026 | Biodeal Pharmaceuticals Ltd Vill Saini MajraNalagarhRopar Road , Nalagarh - 174101 , Distt. Solan (H.P) India | Uniformity of Weights | DTL Srinagar (J&K) |
3. | Cefpodoxime Tablets IP 200 mg (Jan Aushadhi) | CT3096 | 09/2023 | 08/2025 | Bharat Parenterals Ltd Survey No. 144-A, Jarod-SamlayaRoad ,Vill. Haripura , Tal. Savil Dist. Vadodara - 391520 Gujarat India | Assay of Cefpodoxime | CFDL Jammu (J&K) |
4. | DEXTROMETH ORPHAN HYDROBROMI DE | AST- 23303 | Aug-23 | Jul-25 | M/s.AASSK Pharmaceuticals Pvt. Ltd. Plot No.9, S.no 243/2, | On visual inspection dark spots are found on tablet surface.Cappingand | Puducherry |
PHENYLEPHRI NE HYDROCHLOR IDE & CHLORPHENIR AMINE MALEATE TABLETS (Expal) | Dr.AmbedhkarStreet, Kozhumanivakkam, Mangadu, Chennai- 600 122 | lamination defects are found. Some tablets were brittle on opening from the strip - NSQ | |||||
5. | BETAHISTINE DIHYDROCHL ORIDE TABLETS IP (CGHEST-8) | CT242502 84B | May-24 | Apr-26 | M/s CMG BIOTECH PVT. LTS (Unit-II), Plot No. 58, PhaseIII, Industrial Area, Sansarpur Terrace, Tehsil Jaswan, Distt.Kangra, HP- 176501 | On the received sample presence of spots were observed which should not be present As per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discolouration | Puducherry |
6. | METFORMIN HYDROCHLOR IDE TABLETS IP (OKAMET- 500) | 4O30069 | Feb-24 | Jan-27 | M/s.Cipla Ltd., Ropar Road, Nalagarh, Dist. Solan (H.P)-174 101 | Does not comply with respect to the Assay as per IP specification | Puducherry |
7. | PANTOPRAZO LE GASTRO- RESISTANT TABLETS IP 40mg (Pentowok) | WAM2401 1 | May-24 | Apr-26 | M/s Admed Pharma Pvt Ltd., Plot No 87, HPSIDC, Industrial Area, Badddi, DisttSolan HP- 173 205 | Does not comply with respect to the Disintegration test as per IP specification | Puducherry |
8. | ZINC SULPHATE DISPERSIBLE TABLETS IP | TH241106 | Aug-24 | Jul-26 | M/s Orchid MedlifePvt. ltd., (WHO GMP & GLP certified company) | On the received sample chipping and rough surface defects were | Puducherry |
20mg (CARE ZINC) | Vill.Kaundi,P.O Thane, Khasra No. 646/513, Tehsil Baddi, Dist. Solan (H.P)- 173 205. | observed, which should not be present As per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(V) and (VII) respectively | |||||
9. | CEFIXIME AND LACTIC ACID BACILLUS TABLETS (CFI- 200) | T925 | Sep-23 | Aug-25 | M/s. Swiss Biotech Parentrals., Kewat No. 1138,VPO - Kachhwa, Karnal- 132001 (Haryana) | On the received sample presence of spots/discoloration observed which should not be present As per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discoloration | Puducherry |
10. | METFORMIN TABLETS IP 500 mg (GLYCIPHAGE) | G0374057 | Jun-24 | May-27 | M/s.Franco-Indian Pharmaceuticals Pvt Ltd, 20, DR. E. Moses Road, Mumbai-400 011 | Does not comply with respect to the Assay as per IP specification | Puducherry |
11. | Ceaxil -500 Tablets, Cefuroxime Axetil Tablets IP | BT-227375 | 01/2024. | 12/2025. | Dr Edwin Medilabs Pvt Ltd Plot No.B-29, Industrial Area, Focal Point, Chanalon, Kurali, SAS Nagar- 140103(Pb) PUNJAB | White coloured, elongated, biconvex tablets with score on one side, and plain on other side, 10 out of 50 tablets have brown- coloured spots on | State Lab, Drugs Control Laboratory, Telangana. |
the entire surface. Hence, the tablets failed the test for Description of tablets. | |||||||
12. | Jakclav-625 Tablets, Amoxicillin and Potassium Clavulanate Tablets | BPT-3002 | 02/2024. | 01/2026. | Geenac Pharma Plot No: 582, Raipur, Bhagwanpur, Roorkee, Uttarakhand-247667. UTTARAKHAND . Mrkt By: WellnowHelathcare, Kanal Industrial Estate, Road No. 6, Borivali East, Mumbai-400066. | The sample Does not meet the Specifications wrt. Identification test - Negative, Assay- Nil As per IP u/s. 17B of Drugs and Cosmetics Act 1940. the Sample deemed to be SPURIOUS and Misbranded. | State Lab, Drugs Control Laboratory, Telangana. |
13. | Jikcef-LB Tablets, Cefixime and Lactic Acid Bacillus Tablets | BPT-3005 | 02/2024. | 01/2026. | GeenacPharma Plot No: 582, Raipur, Bhagwanpur, Roorkee, Uttarakhand-247667. UTTARAKHAND . Mrkt By: WellnowHelathcare, Kanal Industrial Estate, Road No. 6, BorivaliEast, Mumbai- 400066. | The sample does not meets the Specifications with respect to Identification test-Nil Assay-Nil As per STP u/s. 17B of Drugs and Cosmetics Act 1940. The Sample deemed to be SPURIOUS. | State Lab, Drugs Control Laboratory, Telangana. |
14. | Jikcf-AZ Tablets, Cefixime and Azitromycin Tablets | BPT-3001 | 02/2024. | 01/2026. | Geenac Pharma Plot No: 582, Raipur, Bhagwanpur, Roorkee, Uttarakhand-247667. UTTARAKHAND . | The sample does not meets the Specifications with respect to Identification test-Nil Assay-Nil | State Lab, Drugs Control Laboratory, Telangana. |
Mrkt By: WellnowHelath care, Kanal Industrial Estate, Road No. 6, Borivali East, Mumbai-400066. | As per STP u/s. 17B of Drugs and Cosmetics Act 1940. The Sample deemed to be SPURIOUS. | ||||||
15. | Vithrocin Suspension, Azithromycin Oral Suspension | AZ/L/01/40 09 | 08/2024. | 07/2026. | Vital Therapeutics & Formulations Pvt.Ltd . Plot No. 47b/2, Phase-1, IDA, Cherlapally, Medchal- Malkajgiri District - 500051, Telangana, INDIA. Telangana | As sample failed with respect to test in pH as per IP further product is MISBRANDED | State Lab, Drugs Control Laboratory, Telangana. |
16. | Pantacea 40 Tablets and Pantoprazole Gastro Resistant Tablets IP 40mg | PNTC3007 | 11/2023. | 10/2025. | Windlas Biotech Limited Plant-2, Khasra No. 141 to 143 & 145, MohabewalaIndl.area, Dehradun – 248110 (U.K.) UTTARAKHAND Mrkt By: Panacea Life Sciences Limited, DCM Building, OffceNo.5, Seventh floor, 16 Barakhamba Road, Connauught place, New Delhi- 110001. | The sample Does not complies in respect of Dissolution Test as per IP. | State Lab, Drugs Control Laboratory, Telangana. |
17. | Pantoprazole Sodium Tabletes IP 40mg | P01824 | 08/2024. | 07/2026. | Spansules formulation India Pvt Ltd Sy. No. 172, Plot.No.154/A4 IDA Bollaram (V), Jinnaram (M), Sangareddy (D), Hyderabad | The sample Does not comply in respect of Dissolution Test as per IP. | State Lab, Drugs Control Laboratory, Telangana. |
Telangana | |||||||
18. | Metoprolol Succinate Prolonged Release Tablets IP | URDT0654 | 03/23 | 02/25 | Unicure India Ltd., Plot No. 46(B)/49B Village Raipur, Bhagwanpur ,RoorkeeDist, Haridwar, Uttarakhand | It fails the test ‘Assay’ as per IP standards [Amendment List - 05 to IP 2022] | Drugs Testing Laboratory Thiruvananthapuram |
19. | Metoprolol Succinate Prolonged Release Tablets IP | URDT0653 | 03/23 | 02/25 | Unicure India Ltd., Plot No. 46(B)/49B Village Raipur, Bhagwanpur ,RoorkeeDist, Haridwar, Uttarakhand | It fails the test ‘Assay’ as per IP standards [Amendment List - 05 to IP 2022] | Drugs Testing Laboratory Thiruvananthapuram |
20. | Metoprolol Succinate Prolonged Release Tablets IP | URDT0652 | 03/23 | 02/25 | Unicure India Ltd., Plot No. 46(B)/49B Village Raipur, Bhagwanpur ,RoorkeeDist, Haridwar, Uttarakhand | It fails the test ‘Assay’ as per IP standards [Amendment List - 05 to IP 2022] | Drugs Testing Laboratory Thiruvananthapuram |
21. | Losartan Potassium Tablets IP 50 mg | HLOA09 | 11/23 | 10/25 | Hindusthan Antibiotics Ltd, At 11, W.E.A, Faridabad - 121 001, Haryana | It fails the test ‘Dissolution’ as per IP as specified in the Laboratory Protocol | Drugs Testing Laboratory Thiruvananthapuram |
22. | Amoxymoon CV-625 [Amoxycillin and Potassium Clavulanate Tablets IP] | VT 241704 | 10/24 | 03/26 | VADSP Pharmaceuticals, Plot No.124, EPIP, Indl.Area, Phase-1, Jharmajri, Baddi (H.P) 174 103 | It fails the tests ‘Assay’ and ‘Dissolution’ for Clavulanic Acid as per IP, as specified in the Laboratory Protocol . | Drugs Testing Laboratory Thiruvananthapuram |
23. | Balarishtam | 107 | 09/24 | 10 Yrs. Form packing | Alappat Pharma, Kollam-691503 | It fails the test Total Solids and Specific Gravity as per API | Drugs Testing Laboratory Thiruvananthapuram |
24. | Metformin | D2164/24- | Kerala Medical | It fails the test | Drugs Testing |
Hydrochloride Sustained Release Tab IP 500 mg | 25 | Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram- 14 | microbial contamination in Non-sterile products and Descriptive part for tablets as per IP | Laboratory Thiruvananthapuram | |||
25. | Paracetamol Tab IP 500 mg. | D2370/24- 25 | Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram- 14 | It fails the test ‘Dissolution’ as per IP | Drugs Testing Laboratory Thiruvananthapuram | ||
26. | CIPRODAC 500 (Ciprofloxacin Tablets IP 500mg) | AN24014 | Jan-24 | Dec-26 | Cadila Pharmaceuticals Limited, 1389, Dholka – 382225, Dist: Ahmedabad, At: A-1, Ratan Industrial Area, Harsuliya, Jaipur. C/o. M/S. Anon Pharmaceutical, Jaipur. Mfg. Lic. No.: RAJ/JPR/2718. | The Sample does not conform to standard in respect of the test "Dissolution" performed | State Drugs Testing Laboratory, Agartala, Tripura. |
27. | Metoheal XL 25 (Metoprolol Succinate Extended release Tablets U.S.P) | T24D800A | D/M: Apr/2024 | D/E: Mar/2026 | M/s. Bajaj Formulation, Khasra No.161, Village- LakeshwaryBhagwan pur, RoorkeeDistt: Haridwar (UK) | Test for Dissolution” & content of Metoprolol Succinate in the Assay | Karnataka |
28. | Panik-D Tablets (Pantoprazole Sodium &Domperidone Tablets) | KPT24K08 A | D/M:02/2 024 | D/E:01/202 6 | M/s. Kaizen Pharmaceuticals, Vill. Katha, Baddi-173205 Distt. Solan (H.P) | test for Disintegration | Karnataka |
29. | Fercobate-XT Suspension (Ferrous Ascorbate& Folic acid Suspension) | 240603 | D/M: Jun/2024 | D/E: Nov/2025 | M/s. ShinestarPharma, Begapali Road, SIPOCT-1, Hosur- 635126 (T.N) | Folic Acid in the Assay and Misbranded | Karnataka |
30. | CefpodoximePr oxetil Dispersible Tablets (Qupod- 200 Tablets) | KCT- 403002 | D/M:03/2 024 | D/E:02/202 6 | M/s. Knox Life Sciences, Vill. Gullarwala, Sai Road, Baddi, Distt. Solan (H.P) | Test for Uniformity of Dispersion | Karnataka |
31. | Calcium Carbonate & Vitamin D3 Tablets (Calcovit D3 Tablets) | MWT2311 80 | D/M: Jan/2024 | D/E: Dec/2025 | M/s. MedworPharma, 140 EPIP, Phase-II, Thana, Baddi 173205 | Test for Dissolution for Calcium, Assay for Vitamin D3” and with respect to “Description | Karnataka |
32. | Ranitidine Hydrochloride Injection I.P | AV3082 | D/M: 02/2023 | D/E: 01/2025 | M/s. Alpa Laboratories Ltd., 33/2 A.B. Road, Pigdamber-453 446, Indore (M.P) | Test for Sterility | Karnataka |
33. | Cipex-500 (Ciprofloxacin Tabets I.P) | MUTAD23 01 | D/M: Jun/2023 | D/E: May/2026 | M/s. Maxtar Bio- Genics, K.No.705, Nalagarh Road, MalkuMajra, Baddi- 173205 (H.P) | Test for Dissolution only | Karnataka |
34. | Terbicharge 250 mg (TerbinafineHyd rochloride Tablets IP) | NT-4303 | D/M: 06/2023 | D/E: 05/2025 | M/s. Neptune Life Sciences Pvt. Ltd., 100-B, EPIP, Phase- II, Thana, Baddi- 173205 (H.P) | Test for Dissolution only | Karnataka |
35. | Levocetirizin Hydrochloride &Montelukast Sodium Tablets IP (Montefirst- LC) | 2405097 | D/M: May/2024 | D/E: Apr/2026 | M/s. Aban Pharmaceuticals, Plot No. 1018, Kerala, G.I.D.C., Bavla, Dist. Ahmedabad-382220 | Test for Dissolution of Levocetirizine Hydrochloride and Montelukast | Karnataka |
36. | Paracetamol Tablets IP 650 mg | PCT24135 | D/M: 06/2024 | D/E: 05/2026 | M/s. VivekPharmachem (India) Ltd., NH-8, Chimanpura, Amer, Jaipur-303102 | Test for Dissolution | Karnataka |
37. | Aluminium, | C21A1330 | D/M: | D/E: | M/s. Concept | Description only | Karnataka |
Magnesium &Simethicone Oral Suspension I.P | 03 | 06/2023 | 05/2026 | Pharmaceuticals Ltd., A-28/3, MIDC, Chikalthana, Aurangabad-431006 | |||
38. | ITRACHARGE 200 (Itraconazole Capsules BP) | NC-0805 | D/M: 06/2023 | D/E: 05/2025 | M/s. Neptune Life Sciences Pvt. Ltd., 100-B, EPIP, Phase- II, Thana, Baddi- 173205 (H.P) | Dissolution Test only | Karnataka |
39. | Ondansetron Injection IP-2ml | A24AM130 | 04/2024 | 03/2026 | Skymap Pharamceuticals Pvt. Ltd, B-2 Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee - 247 667 | sample does not conform to requirement for assay and related substances | King Institute of Preventive Medicine & Research, Guindy, Chennai-32 |
40. | Cipladine Multipurpose Antiseptic Skin Ointment | CH040103 | 03/2024 | 02/2026 | HSN International, At Plot No.54-55, Sector 6A, I.I.E, Sidcul, Haridwar, Uttarakhand,249403. | Sample does not conform to USP specification for povidone-Iodine Ointment with respect to content of available Iodine in povidone Iodine. | Drugs Testing Laboratory, Chennai - 6 |
41. | Povidone- Iodine Ointment USP | VG24025 | 04/2024 | 03/2026 | Microwin Labs PVt Ltd, Plot No.363, Industrial Focal Point, Phase-9, Mohali- 160062. | Sample does not conform to USP Spcification for povidine-IODINE Ointment with respect to the content of Avaible Iodine in povidone Iodine. | Drugs Testing Laboratory, Madurai - 19. |
42. | Atorvastatin Calcium Tablets IP 10mg | HTN414D | 04/2024 | 03/2026 | Himalaya Meditek Pvt. Ltd, Plot No. 35 & 36, Pharmacity, Selaqui, Industrial Area, Dehradun - 248 | Sample does not conform to IP Specification for Atorvastatin Calcium Tablets | Drugs Testing Laboratory, Chennai - 6 |
197 | with respect to Dissolution | ||||||
43. | Atorvastatin Calcium Tablets IP 10mg | HTN405D | 04/2024 | 03/2026 | Himalaya Meditek Pvt. Ltd, Plot No. 35 & 36, Pharmacity, Selaqui, Industrial Area, Dehradun - 248 197 | Sample does not conform to IP Specification for Atorvastatin Calcium Tablets with respect to Dissolution | Drugs Testing Laboratory, Chennai - 6 |
44. | Ciprofloxacin Hydrochloride Tablets IP 500mg | HTN1126L | 11/2023 | 10/2025 | Himalaya Meditek Pvt. Ltd, Plot No. 35 & 36, Pharmacity, Selaqui, Industrial Area, Dehradun - 248 197 | Sample does not conform to IP specification for ciprofloxacin tablets with respect to Dissolution | Drugs Testing Laboratory, Chennai - 6 |
45. | Amlod-At | DT240289 | 02/2024 | 01/2026 | Daeiou Pharmaceutical (P) Ltd, R.S.No.158, Puducherry - Villupuram Main Road, Villianur, Puducherry, 605110. | Sample does not conform to IP Specification for Amlodipine and Atenolol Tablets with respect to Dissolution for Amlodipine and to the Content of Amlodipine in Amlodipine in Amlidipine Besylate. | Drugs Testing Laboratory, Chennai - 6 |
46. | Glimepiride Tablets IP 1mg | PGG24- 002 | 06/2024 | 05/2026 | Pondchy Pharmaceuticals, R.S.No.218/4, 218/5, Odiaampet, Manaveli Road, Villianur Commune, Puducherry, 605110. | Sample does not conform to IP specification for Glimepiride Tablets with respect to Dissolution. | Drugs Testing Laboratory, Chennai - 6 |
47. | Snikuf 4 | RZAB01 | 05/2023 | 04/2025 | Akums Drugs & Pharmaceuticals Ltd, 22, Sector-6A, I.I.E, Sidcul. Ranipur, | Sample does not conform to label claim with respect to the content of | Drugs Testing Laboratory, Chennai - 6 |
Haridwar-249403, Uttrakhand. | Terbutaline Sulphate. | ||||||
48. | Trubery LS | Z-23388 | 09/2023 | 08/2025 | CSD Lifesciences, Village Malkumajra, Morepen Road, Baddi, Distt, Solan, (H.P). 173205. | Sample does not conform to Label with respect to the content of Levosalbutamol in Levosalbutamol sulphate. | Drugs Testing Laboratory, Chennai - 6 |
49. | Sucrazum-O Suspension | ALL-899 | 08/2023 | 07/2025 | Access Life Science, Khasra No.551/3, Village Taksal, Parwanoo, Distt, Solan (HP), 173220. | Sample does not conform to Label claim with respect to the content of Oxetacaine. | Drugs Testing Laboratory, Chennai - 6 |
50. | Rosuvastatin, Aspirin & Clopidogrel Capsules (20mg/75mg/75 mg) | MC240184 | 02/2024 | 01/2026 | Mascot Health Series Pvt Ltd., Plot No. 79, 80 Sec-6A, IIE, Sidcul, Haridwar- 249 403 | Sample does not conform to Label claim with respect to the content of Aspirin and to Schedule V of Drugs and Cosmetics Act, with respect to free Salicylic Acid. | Drugs Testing Laboratory, Chennai - 6 |
51. | Metoclopramide HCL Injection I.P-2ml | 24DQC64 | 03/2024 | 02/2026 | SVP Life Sciences, C/10-1, Sara Industrial Estate, Selaqui, Dehradun | sample does not conform to the requirement for Assay of Metoclopramide | King Institute of Preventive Medicine & Research, Guindy, Chennai-32 |
52. | Metoclopramide HCL Injection I.P-2ml | HLI405D | 04/2024 | 03/2026 | Himalaya Meditek Pvt. Ltd, Plot No. 35 & 36, Pharmacity, Selaqui, Industrial Area, Dehradun - 248 197 | sample does not conform to the requirement for Assay of Metoclopramide | King Institute of Preventive Medicine & Research, Guindy, Chennai-32 |
53. | Amitriptyline Tablets IP 25mg | TA24159 | 04/2024 | 03/2026 | Saintlife Pharmaceuticals Ltd, 323, Central Hope | Sample does not conform to IP specification for | Drugs Testing Laboratory, Chennai - 6 |
Town, Industrial Area, Selaqui, Dehradun - 248 011, Uttarakhand, India | tablets with respect to Definition. | ||||||
54. | Megapure-TZ IU suspension | 23L-162 | 09/2023 | 08/2025 | Prispag Pharma, Roomi, Jagraon - 142030. | Sample does not conform to label claim with respect to the content of Ciprofloxacin in Ciprofloxacin Hydrochloride and Tinidazole. | Drugs Testing Laboratory, Chennai - 6 |
55. | Octenidine Dihydrochlordie Gel | PPKAC84 | 05/2023 | 04/2026 | Pure & Cure Healthcare Pvt Ltd, (A Subsidiary of Akums Drugs & Pharmaceuticals Ltd,) Plot No.26A,27-30, Sector - 8A,IIE, Sidcul, Haridwar- 249403. Uttarakhand. | Sample does not conform to label claim with respect to the content of Octenidine Dihydrochloride. | Drugs Testing Laboratory, Madurai - 19. |
56. | Dexamethasone Tablets IP 0.5mg | TA24036 | 01/2024 | 12/2025 | Saintlife Pharmaceuticals Ltd, 323, Central Hope Town, Industrial Area, Selaqui, Dehradun - 248 011, Uttarakhand, India | Sample does not conform to IP Specification for Dexamethasone Tablets with respect to the content of Dexamethasone. | Drugs Testing Laboratory, Chennai - 6 |
57. | Dexamethasone Tablets IP 0.5mg | TA24035 | 01/2024 | 12/2025 | Saintlife Pharmaceuticals Ltd, 323, Central Hope Town, Industrial Area, Selaqui, Dehradun - 248 011, Uttarakhand, India | Sample does not conform to IP Specification for Dexamethasone Tablets with respect to the content of Dexamthasone. | Drugs Testing Laboratory, Chennai - 6 |
58. | Peedon | P2409 | 05/2024 | 04/2026 | Sharing formulations Pvt Ltd, Plot No.41,G.I.D.C, | Sample does not conform to label claim with respect | Drugs Testing Laboratory, Chennai - 6 |
Waghodia, Vadodara. 391760. | to the content of Available Iodine in Povidone-Iodine. | ||||||
59. | Esilac Soluion | ZBL-1154 | 12/2023 | 11/2025 | Zoic Biotech Pvt Ltd, Plot No.C-15, Focal Point, Ind. Area, Chanalon, Mohali, (Punjab), 140103. | Sample does not conform to USP Specification for Lactulose Solution with respect to the Content of Lactulose in Lactulose Concentrate. | Drugs Testing Laboratory, Chennai - 6 |
60. | Amoxycillin Dispersible Tablets IP 125 mg | PGA24- 002 | 03/2024 | 02/2026 | Pondchy Pharmaceuticals, R.S.No.218/4, 218/5, Odiaampet, Manaveli Road, Villianur Commune, Puducherry, 605110. | Sample does not conform to IP Specification for Dispersible Tablets with respect to uniformity of Dispersion and Disintegration | Drugs Testing Laboratory, Chennai - 6 |
61. | Orsiclop-A75 | NTT24103 6 | 03/2024 | 02/2026 | Nanoceut Therapeutics Pvt Ltd, R.S.No. 104/19A, E.V.R.Street, Sedarapet, Puducherry, 605111 | Sample does not conform to IP specification for Clopidogrel and Aspirin Tablets with respect to Dissolution ( Clopidogrel and Aspirin), Free Salicylic Acid (Related substance for Aspirin) and to the content of ASpirin | Drugs Testing Laboratory, Chennai - 6 |
62. | Iron Sucrose Injection USP- 5ML | PGY23118 | 08/2023 | 07/2025 | Affy Parenterals, Vill. Gullerwala, P.O. Baddi, Distt. Solan - 173 205 (H.P) | Sample does not conform to requirement for assay for iron. | King Institute of Preventive Medicine & Research, Guindy, Chennai-32 |
63. | Justkof-LS | UF267408 2F | 01/2024 | 12/2025 | Ultra Drugs Formultations Pvt Ltd, Plot No.338/278, Vill. Manakpur, Lodhimajra, Tehsil- Baddi, Distt. Solan (HP)-173205. | sample does not conform to Label claim with respect to the content of Ambroxol Hydrochloride. | Drugs Testing Laboratory, Madurai - 19. |
64. | Gabacure Gel | HUAA46 | 06/2024 | 11/2025 | Akums Druges & Pharmaceuticals Ltd. 47,48,Sector-6A, I.I.E., SIDCUL,, Haridwar-249 403, Uttarakhand. | Sample does not conform to Label claim with respect to the content of Gobapentin. | Drugs Testing Laboratory, Madurai - 19. |
65. | Dexamethasone Injection IP-2ml | FDDTI-004 | 02/2024 | 01/2026 | Laborate Pharmaceuticals India Ltd, 51 Indl. Area, Paonta Sahib (HP). | Sample does not conform to requirement for Assay. | King Institute of Preventive Medicine & Research, Guindy, Chennai-32 |
66. | Ondansetron Tablets IP 4 mg | 320D2401 | 04/2024 | 03/2026 | SSM Formulations Private Limited, Survey No. 11/1, Mouza Ashti (Rith), Hinganghar (M.H), 442301 | Sample does not conform to IP Specification for Ondansetron Tablets with respect to Dissolution. | Drugs Testing Laboratory, Chennai - 6 |
67. | O Mak-200 | VMWT240 7 | 06/2024 | 03/2026 | Vertex Pharma Chemicals, Plot No.60-A,61-A, PIPDIC Electronic Park, Tirubhuvanai, Puducheryy-605107. | Sample does not conform to IP Specification of Ofloxacin Tablets with respect to the content of Ofloxacin. | Drugs Testing Laboratory, Madurai - 19. |
68. | Retrazith-250 | WT3927F | 03/2024 | 02/2026 | Saphnix Life Sciences, Village- Barotiwala, Paonta Sahib,Distt, Siramour, Himachal Pradesh- 173025 | Sample does not conform to IP specification for Azithromycin Tablets with respect to Dissolution and to the Content of Anhydrous | Drugs Testing Laboratory, Chennai - 6 |
Azithromycin Dihydrate. | |||||||
69. | Surgi Spirit | SS-084032 | 08/2024 | 07/2026 | Transflex, Hawahar Nagar, Ranipur (C.G),492001. | Sample does not conform IP Specifciation for Surgical Spirit with respect to weight per ml. | Drugs Testing Laboratory, Chennai - 6 |
70. | Brokuf-DM | CBL- 0024/24 | 02/2024 | 01/2026 | C.B.Healthcare, Village Messa Tibba, Tehsil Nalagarh, Distt, Solan (H.P),174101. | Sample does not conform to Label claim with respect to the content of phenylephrine Hydrochloride. | Drugs Testing Laboratory, Chennai - 6 |
71. | Tamcof-Ls Syrup | AGL23022 1C | 03/2024 | 02/2026 | Asterisk Healthcare, V.P.O Bathri, Thesil Haroli, Distt. Una (H.P),174301. | Sample does not conform to Label claim with respect to the content of Ambroxol Hydrochloride | Drugs Testing Laboratory, Chennai - 6 |
72. | Cadcof-Lx Syrup | DLS2378 | 06/2024 | 05/2026 | Dhwanilife Care Pvt Ltd, Plot No.C-20/2, (C-39) & C-20/3, (C- 40), Arvind Mega Parek, Village- Chachravadi Vasna, Ahmedabad, Gujarat- 382213. | Sample does not conform to Label Claim with respect to the content of Levosalbutamol in Levosalbutamol Sulphate, Ambroxol Hydrochloride and Guaiphenesin. | Drugs Testing Laboratory, Chennai - 6 |
73. | Co-Trimoxazole Tablets IP 480mg | MT404 | 01/2024 | 12/2026 | Maxwell Lifescience Pvt Ltd, T-53 & T-81, M.I.D.C, Tarapur, Boisar, Dist, Palghar, 401506. | Sample does not conform to IP Specification for Co- Trimoxazole Tablets with respect to Dissolution for Sulphamethoxazole | Drugs Testing Laboratory, Chennai - 6 |
74. | Cipladine | CHO40018 | 01/2024 | 12/2025 | HSN International, At point No.54-55, | Sample does not conform to USP | Drugs Testing Laboratory, Madurai - |
Sector 6A, I.IE, Sidcul Haridwar, (Uttarakhand), 249403 | Specification for Povidone- Iodine Ointment with respect to the content of Avaible Iodine in Povidone Iodine, | 19. | |||||
75. | Cipladine Ointment | CHO40020 | 01/2024 | 12/2025 | HSN International, At point No.54-55, Sector 6A, I.IE, Sidcul Haridwar, (Uttarakhand), 249403 | Sample does not conform to USP Specification for Povidone-Iodine Ointment with respect to the content of Avaible Iodine in Povidone Iodine. | Drugs Testing Laboratory, Madurai - 19. |
76. | Atovaris-F | DEMT- 240124B | 04/2024 | 03/2026 | Dr.Edwin Medilabs Pvt Ltd, Plot No.B-29, Industrial Area, Focal Point, Chanalon, Kurali, SAS Nagar- 140103(pb). | Sample does not conform to IP Specification with respect to Uniformity of Weight. | Drugs Testing Laboratory, Madurai - 19. |
77. | Capiwash Mouthwah | FL-050B | 08/2023 | 07/2025 | Forgo Pharmaceuticals, 27, Dic Ind Area, Barotiwala, the Baddi, Distt, Solan (H.P)- 174103 | Sample does not conform to IP Specification for Chlorhexidine Mouthwash IP with respect to the content of Chlorhexidine Gluconate in Chlorhexidine Gluconate Solution. | Drugs Testing Laboratory, Madurai - 19. |
78. | Povidone- Iodine Ointment USP | VG23017 | 11/2023 | 10/2025 | Microwin Labs PVt Ltd, Plot No.363, Industrial Focal Point, Phase-9, Mohali- 160062. | Sample does not conform to USP Specification for Povidone - Iodine Ointment with | Drugs Testing Laboratory, Madurai - 19. |
respect to the content of Avaible Iodine in Povidone Iodine. | |||||||
79. | Flucent Pour-on Solution | PB-105/12 | 12/2023 | 11/2025 | Indo Gulf Pharmaceuticals, 5.4 K.M, Meerut Road, Muzaffarnagar (U.P) | Sample does not conform to Label claim with respect to Identification and Content of Flumethrin. | Drugs Testing Laboratory, Madurai - 19. |
80. | Betamethasone Valerate Ointment IP 01% w/w | B06 | 05/2024 | 04/2026 | Syndicate Pharma, 185/B, 185/B-1, 187/A & 188, sector -F, Sanwer Road, Indore- 452015. | Sample does not conform to IP specification for Betamethasone Valerate Ointment with respect to the content of Betamethasone in Betamethasone Valerate. | Drugs Testing Laboratory, Madurai - 19. |
81. | Clobium Suspension. Clobazam Oral Suspension BP 5mg | TYOL-047 | 07/2024 | 06/2026 | Tanmed Pharma (I) Pvt Ltd, No.1/429, Multi Industrial Nagar, Gerugambakkam, Chennai-600128 | Sample does not conform to BP specification for Clobazam Oral Suspension with respect to Dissolution and to the content of Clobazam | Drugs Testing Laboratory, Chennai- 6 |
82. | Chlorpheniramin e Maleate Injection | IAL77/23 | 12/2023 | 11/2025 | Anra Pharamaceuticals Pvt Ltd, Madurai-Melur Road, Vellaripati, Madurai-625122 | Sample does not conform to the requirement for Assay for Chlorpheniramine | King Institute of Preventive Medicine & Research, Guindy, Chennai-32 |
83. | Chro-B Gold | DCBGT- 2402 | 09/2024 | 02/2026 | Kniss Laboratories (P) Ltd, Plot No. 9, Multe Industrial Estate, | Sample does not conform to label claim with respect to the content of | Drugs Testing Laboratory, Chennai - 6 |
Gerugambakkam, Chennai - 600 128 | Cholecalciferol | ||||||
84. | Atorvastatin Tablets IP 10mg | A283 | 04/2024 | 03/2026 | Rikenbik Pharma, 113, SIDCO Industrial Estate, Ambattur, Chennai-600098. | Sample does not conform to IP Specification for Atorvastatin Calcium Tablets with respect to Dissolution. | Drugs Testing Laboratory, Chennai - 6 |
To view the official notice, click the link below:
