CDSCO Flags 55 Substandard, 4 Spurious Drugs in June Batch Alert, Full List Inside
New Delhi: In its latest regulatory update for June 2025, the Central Drugs Standard Control Organisation (CDSCO) has flagged a total of 55 drug batches as Not of Standard Quality (NSQ) and 4 as spurious, based on reports submitted by national drug testing laboratories.
The findings, published under CDSCO's monthly surveillance, reveal significant quality issues in various injectable formulations, antibiotics, vitamins, and antihypertensive drugs, while spurious drugs included commonly used brands like Taxim-O 200 (Cefixime) and Thrombophob ointment.
“The purpose of displaying the NSQ and spurious drugs list is to make stakeholders aware about the substandard and counterfeit batches identified in the market,” the CDSCO noted in its public alert. All flagged batches were drawn by state drug inspectors and tested at Central Drug Testing Laboratories (CDLs) in Kolkata, Mumbai, Hyderabad, Guwahati, and Indore.
According to the NSQ Alert for June 2025, a total of 55 drug samples failed quality checks due to a variety of issues, including assay failures, sterility concerns, particulate contamination, improper dissolution, and labeling errors.
Among the major violations were rabeprazole formulations manufactured by M/s Martin & Brown Bio-Sciences Pvt. Ltd. and M/s Athens Life Sciences, which were found to have defects in assay, particulate matter, and product description. Similarly, a batch of paracetamol IV infusion manufactured by D.J. Laboratories Pvt. Ltd. was flagged for visible particulate contamination, posing risks in intravenous administration.
E.G. Pharmaceuticals' Eldervit-12 vitamin injection was cited for failure related to particulate matter and description, while Oxytocin Injection from Systochem Laboratories Ltd. and Heparin Injection from Divine Laboratories — both critical medicines used in hospital settings — failed assay and sterility tests. Additionally, batches of Gentamicin Injection and Adrenaline Bitartrate Injection were found non-compliant due to failures in sterility, pH levels, and labeling description.
NOT OF STANDARD QUALITY (NSQ) ALERT FOR THE MONTH OF JUNE-2025 (CDSCO/Central Laboratories)
S.No | Product/Drug Name | Batch No. | Manufact uring Date | Expiry Date | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
1. | Dextrose Injection I.P. 5%w/v (D5) | 1-3098 | 01/2025 | 12/2027 | M/s. Tam-Bran Pharmaceuticals Pvt. Ltd., Plot No. 212 & 216, Sector-1, Industrial Area, Pithampur, District-Dhar (M.P.) India454775 | Assay of Dextrose (Anhydrous) | CDL, Kolkata |
2. | Dexamethasone Sodium Phosphate Injection I.P. (Dexacos) | P24L220 | 12/2024 | 11/2026 | M/s. Paksons pharmaceuticals Private Limited, 36, Milestone, Delhi Rohtak Road, Sankhol, Bahadurgarh-124507, Haryana | Free Dexamethasone, Particulate matter and Description | CDL, Kolkata |
3. | Methylcobalamin Injection | S4H046 | 08/2024 | 01/2026 | M/s. Arion Healthcare, Vill. Kishanpura, Baddi, Distt. Solan-174101(H.P.) | Assay of Methylcobalamin, Particulate matter and Description | CDL, Kolkata |
4. | Tranexamic Acid Injection IP 500 mg/5ml | Z24-185 | 02/2024 | 01/2026 | M/s. Zee Laboratories Ltd., Behind 47, Industrial Area, Paonta Sahib-173025 | Related Substances and Assay of Tranexamic Acid | CDL, Kolkata |
5. | Oxytocin Injection I.P. 1ml | AOX-2402 | 04/2024 | 03/2026 | M/s. Systochem Laboratories Ltd., B-75 Roop Nagar, Indl. Area, Loni-201102(U.P.) | Assay of Oxytocin | CDL, Kolkata |
6. | Calcium Aspartate, Calcium Orotate, Calcitriol Minerals And Vitamin Tablets | EZF-2107 | 11/2024 | 04/2027 | M/s. Overseas Health Care Pvt. Ltd., 335 Km. Milestone, National Highway No. 1, P.O. Box No. 25, Phillaur - 144 410 (Pb.) | Assay of Calcitriol, Zinc, Magnesium Hydroxide and Folic Acid | CDL, Kolkata |
7. | Ascorbic Acid Injection I.P. (Vitson-C) | P25L269 | 02/2025 | 01/2027 | M/s. Paksons Pharmaceuticals Private Limitated, 36, Milestone, Delhi Rohtak Road, Sankhol, Bahadurgarh- 124507, Haryana | Particulate Matter and Description | CDL, Kolkata |
8. | Adrenaline Injection IP (Aline Injection 1 ml.) | AL-92 | 02/2025 | 04/2026 | M/s. Aster Medicines Pvt. Ltd., Plot No. E4(Part), Industrial Area Phase II, Hazipur-844101 | Particulate Matter and Description | CDL, Kolkata |
9. | Calcium Gluconate Injection I.P. 10 ml. | MV24B36 | 02/2024 | 01/2026 | M/s. Martin & Brown Bio- Sciences Pvt.Ltd., K.No- 918/419, Malkumajra, Nalagarh Road, Baddi, DistSolan, HP-173205 | Particulate Matter, Extractable Volume and Description | CDL, Kolkata |
10. | Rabeprazole Sodium (EC) & Domperidone (SR) Capsules (Sesarab-DSR Capsules ) | CG23-0372F | 09/2023 | 08/2025 | M/s. Athens Life Sciences, Mauza Rampur Jattan, Nahan Road, Kala Amb, Distt. Sirmour, H.P.-173030 | Assay of Rabeprazole Sodium | CDL, Kolkata |
11. | Heparin Injection IP 5000 IU/ml (Flagorin) | DP2143 | 08/2022 | 06/2025 | M/s. Divine Laboratories Pvt. Ltd., Block No. 471, Dabhasa, Tal. Padra, Dist. Vadodara- 391440, India | pH and Assay of Heparin (Antifactor-IIa activity) | CDL, Kolkata |
12. | Adrenaline Bitartrate Injection I.P. 1 ml (Aderson Inj.) | P25L262 | 02/2025 | 07/2026 | M/s. Paksons Pharmaceuticals Private Limited, 36, Milestone, Delhi Rohtak Road, Sankhol, Bahadurgarh-124507, Haryana | Particulate Matter, pH and Description | CDL, Kolkata |
13. | Methylcobalamin 1500 mcg (Nuroark) | JIN24-041 | 08/2024 | 01/2026 | M/s. Janya Biocare Pvt. Ltd., Khasra No.-169, Tanshipur, Roorkee (U.K.) | Description and Particulate Matter | CDL, Kolkata |
14. | Calcium Aspartate, Calcium Orotate, Calcitriol, Minerals and Vitamins Tablets | EZF-2067 | 10/2024 | 03/2027 | M/s. Overseas Health Care Pvt. Ltd. 335 km, Milestone National Highway No. 1 P.O. Box No. 25, Phillaur-144 410(Pb.) | Assay/ Content of Folic Acid, Zinc and Magnesium Hydroxide | CDL, Kolkata |
15. | Fosfomycin Phenyl Ethyl Amine | 20240901 | 12-09-2024 | 11-09- 2026 | M/s. Shayamg Qinjiang Chemical, Add:-No. I Qinjing Chemical Park, Shayang Economic Development Zone, Hubei, China, Postal Code448200 | Specific Optical Rotation | CDL, Kolkata |
16. | Gentamicin Injection IP (Gentacos) | P24L199 | 12/2024 | 11/2026 | M/s. Paksons Pharmaceuticals Private Limited, Delhi Rohtak Road, Ganpati Industrial area, Sankhol, Bahadurgarh- 124507(HR), INDIA | Sterility, Particulate Matter and Description | CDL, Kolkata |
17. | Docetaxel Anhydrous IP | DXT2024120 40 | 12/2024 | 12/2026 | M/s. Sanghai Jinhe BioPharmaceutical Co. Ltd. 508, Maodian Road, Qingpu District, Shanghai-201716, China | Water | CDL, Kolkata |
18. | Ketoconazole & Zinc Pyrithione Shampoo (Ketocross Shampoo) | L25Y2002 | 03/2025 | 02/2027 | M/s. Om Sai Pharma Pack, Plot No. 38 & 39,Sector- 11,IIE,SIDCUL,Distt. Haridwar, Uttarakhand-249403 | Assay of Zinc Pyrithione | CDL, Kolkata |
19. | Vitamin C Injection IP and Vitamin B12, Folic Acid and Niacinamide Injection (Eldervit B 12) | VHI034047 | 08/2024 | 07/2026 | M/s. Vidit Healthcare, Village Kishanpura, Paonta Sahib, Distt. Sirmour, H.P.-173025 | Particulate Matter and Description | CDL, Kolkata |
20. | Vitamin C Injection IP and Vitamin B12, Folic Acid and Niacinamide Injection (Eldervit-12 Injection) | IEW1433B | 07/2024 | 06/2026 | M/s. E.G. Pharmaceuticlas, Vill. Mandhala, Teh. Baddi, Distt. Solan (H.P.) | Particulate Matter and Description | CDL, Kolkata |
21. | Rabeprazole Sodium Injection I.P. | MD23H23 | 08/2023 | 07/2025 | M/s. Martin & Brown Bio- Sciences Pvt.Ltd., K.No- 918/419, Malkumajra, Nalagarh Road, Baddi, DistSolan, HP-173205 | pH, Clarity of Solution, Particulate Matter, Assay of Rabeprazole Sodium and Description | CDL, Kolkata |
22. | Clotrimazole Ear Drops | CLT-214A | 08/2024 | 07/2026 | M/s. Pushkar Pharma, Kheri, Kala-Amb-173030 (H.P.) | Assay of Clotrimazole | CDL, Kolkata |
23. | Raberpazole (EC) & Domperidone (SR) Capsules (Rabeton-DSR) | SC-15114 | 10/2024 | 09/2027 | M/s. Sunvij Drugs Private Limited, 511, GIDC, Waghodia, Baroda-391760, Gujarat | Assay of Rabeprazole Sodium | CDL, Kolkata |
24. | Telmisartan Tablets IP 40 mg | ALPT-051 | 07/2024 | 06/2026 | M/s. Alifecare Pharmacy Pvt Ltd, VPO-Barog, Teh & Distt. Solan (H.P.) -173212 | Dissolution of Telmisartan | CDL, Kolkata |
25. | Vitamin C Injection IP and Vitamin B12, Folic Acid and Niacinamide Injection (Eldervit-12 Injection ) | B.no: IEW1480C, IEW-1480B | 09/2024 | 08/2026 | M/s. E.G.Pharmaceuticals, Vill. Mandhala, Tehsil: Baddi Distt.Solan (H.P.) | Particulate Matter and Description | CDL, Kolkata |
26. | Vitamin C Injection IP and Vitamin B12, Folic Acid and Niacinamide Injection (Eldervit-12 Injection ) | B.no: IEW-1487C, IEW-1487B | 09/2024 | 08/2026 | M/s. E.G.Pharmaceuticals, Vill. Mandhala, Tehsil: Baddi Distt.Solan (H.P.) | Particulate Matter and Description | CDL, Kolkata |
27. | 3% Sodium Chloride Injection USP | G25B016 | 02/2025 | 01/2027 | M/s. Inven Pharmaceuticals Pvt. Ltd., Village Kalsada Khurd, District-Dhar (M.P.)454001 | Particulate Matter in Injections | CDL, Kolkata |
28. | Ondansetron Injection IP (Ondson Inj.) | P24L189 | 11/2024 | 10/2026 | M/s. Paksons Pharmaceuticals Private Limited, 36, Milestone, Delhi Rohtak Road, Sankhol, Bahadurgarh-124507, Haryana | Particulate Matter and Description | CDL, Kolkata |
29. | Sitagliptin & Metformin Tablets 50mg + 1000mg (Sitajack-M) | T-2672 | 09/2024 | 08/2026 | M/s. Jackson Laboratories Pvt.Ltd. 22-24, Majitha Road, Bye Pass, Amritsar- 143001(India) | Assay of Sitagliptin | CDL, Kolkata |
30. | Cefotaxime Sodium Injection IP 1g | 1172 | 08/2023 | 07/2025 | M/s. Hindustan Antibiotics Ltd., Pimpri,Pune-411018,India | Water | CDL, Kolkata |
31. | Amikacin Sulphate Injection IP (Lamic-500 Injection ) | L-24K-31H | 11/2024 | 10/2026 | M/s. Inmac Laboratories, Bangsipura-142033 (Pb.) | Particulate Matter, Assay and Description | CDL, Kolkata |
32. | Pantoprazole Sodium for Injection (K Pan-IV Injection) | GD24L-27H | 12/2024 | 11/2026 | M/s. Vellinton Healthcare, Trilokpur Road,Vill-Rampur Jattan, Kala-Amb-173030 Distt. Sirmour (H.P.) | Sterility | CDL, Kolkata |
33. | Pantoprazole Gasrro- Resistant and Domperidone Prolonged Release Capsules IP (Prazentasure-DSR Capsules) | NC24004 | 09/2024 | 08/2026 | M/s. Nexkem Pharmaceuticals Pvt. Ltd., Plot No.119, HPSIDC Industrial Area Baddi, Dist. Solan (H.P.)-173205 | Dissolution of Pantoprazole in Buffer Stage | CDL, Kolkata |
34. | Diclofenac Sodium Injection IP (ZOR INJ.) | P25L265 | 02/2025 | 01/2027 | M/s. Paksons Pharmaceuticals Private Limited, 36, Milestone, Delhi Rohtak Road, Sankhol, Bahadurgarh-124507, Haryana | Extractable Volume | CDL, Kolkata |
35. | Rabeprazole Sodium Injection IP | MD23H12 | 08/2023 | 07/2025 | M/s. Martin & Brown Bio- Sciences Pvt.Ltd., K.No- 918/419, Malkumajra, Nalagarh Road, Baddi, DistSolan, HP-173205 | pH, Clarity of Solution, Uniformity of Weight, Particulate Matter and Assay of Rabeprazole Sodium | CDL, Kolkata |
36. | Amoxycillin and Potassium Clavulanate Injection IP | ACP-738A | 09/2023 | 08/2025 | M/s. Pushkar Pharma, Kheri, Kala-Amb-173030 (H.P.) | Assay of Potassium Clavulanate equivalent to Clavulanic Acid | CDL, Kolkata |
37. | Methycobalamin, Calcitriol, Omega-3 Fatty Acids (EPA & DHA), Folic Acid, Boron, Calcium Carbonate Softgel Capsules (Biofil-Max Softgel Capsules ) | HPDJ24170 | 10/2024 | 09/2026 | M/s. Healthwise Pharma, VPO Bhud, Teh.Baddi, Distt-Solan (H.P.)-173205 | Assay of Docosahexaenoic Acid, Eicosapentaenoic acid | CDL, Kolkata |
38. | Paracetamol Intravenous Infusion (1.0% w/v ) | E25B026 | 02/2025 | 01/2028 | M/s. D.J. Laboratories Pvt. Ltd., 255, Sector-1, Industrial Area, Pithampur-454775 | Particulate Contamination | CDL, Kolkata |
39. | Telmisartan Tablets IP 40 mg | TLL-504 | 01/2025 | 12/2026 | M/s.Healers Lab Unit II, Plot No. 33, H.P.S.I.D.C., Extn.,Baddi, Distt-Solan (H.P) | Dissolution of Telmisartan | RDTL, Guwahati |
40. | Telmisartan Tablets IP 40 mg | TLL-503 | 01/2025 | 12/2026 | M/s.Healers Lab Unit II, Plot No. 33, H.P.S.I.D.C., Extn.,Baddi, Distt-Solan (H.P) | Dissolution of Telmisartan | RDTL, Guwahati |
41. | Telmisartan Tablets IP (Telzasig 20) | TEZC25001 | 04/2025 | 03/2027 | M/s.Signova Healthcare Pvt. Ltd (Unit-II), EPIP Silasundari, | Dissolution of Telmisartan | RDTL, Guwahati |
Ghopa, Amingaon, North Guwahati, Assam-781031 | |||||||
42. | Infusion Set-NV | KT-071 | 11/2024 | 10/2027 | M/s. Medivision Healthcare, 84/4 Span Industrial complex. Second Floor, Phase-1, F Road, Opp. Kotak Mahindra Bank, G.I. D.C. Vatva, Ahmedabad- 382445 | Sterillity | RDTL, Guwahati |
43. | Calcium & Vitamin D3 Tablets IP (Calciven-500) | T-240267 | 06/2024 | 05/2026 | M/s. Sunlife Sciences,, 130, Kurdi, Jhabrera Road, Manglour, Roorkee, Distt. Haridwar (U.K.) | Assay of Vitamin D3 | RDTL, Guwahati |
44. | Pantoprazole Tablets IP 20 mg (Opipan- 20) | 23G-T1503 | 10/2023 | 09/2025 | M/s. Orison Pharma International, Vill. Khari, Mauza Ogli, Kala Amb, Distt. Sirmour - 173030 (H.P.) | Dissolution in Acid Stage & Description | RDTL, Guwahati |
45. | Azithromycin Tablets IP 500 mg. | AYC-2407 | 01/2024 | 12/2025 | M/s.Apple Formulations Pvt. Ltd., Plot No.208, Kishanpur, Roorkee- 247667(U.K.) | Dissolution of Azithromycin | RDTL, Guwahati |
46. | Colestyramine BP | SB43/001M/ 24 | 07/2024 | 07/2029 | M/s. Phaex Polymers Private Limited Plot No. : F-10, MIDC, Murbad, Dist- Thane-421401, Maharastra. | Loss on drying | CDTL-Mumbai |
47. | Cholestyramine Resin USP | SB45/001M/ 24 | 07/2024 | 07/2029 | M/s. Phaex Polymers Private Limited Plot No. : F-10, MIDC, Murbad, Dist- Thane-421401, Maharastra. | Loss on drying | CDTL-Mumbai |
48. | Colestyramine EP | SB48/001M/ 24 | 07/2024 | 07/2029 | M/s. Phaex Polymers Private Limited Plot No. : F-10, MIDC, Murbad, Dist- Thane-421401, Maharastra. | Loss on drying | CDTL-Mumbai |
49. | 0.45 % w/v Sodium Chloride and 5 % w/v Dextrose Injection I.P. (0.45 % DNS), 500 ml | S3BX05 | 11/2024 | 10/2026 | M/s.Swaroop Pharmaceuticals Pvt. Ltd., A-10, Tala Nagari Industiral Area, Aligarh 202001. | Test for Sterility | CDTL-Mumbai |
50. | Sodium Polystyrene Sulfonate EP | SC42/048M/ 24 | 07/2024 | 07/2029 | M/s. Phaex Polymers Private Limited Plot No. : F-10, MIDC, Murbad, Dist- Thane-421401, Maharastra. | Loss on drying | CDTL-Mumbai |
51. | Sodium Polystyrene Sulfonate USP | SC25/048M/ 24 | 07/2024 | 07/2029 | M/s. Phaex Polymers Private Limited Plot No. : F-10, MIDC, Murbad, Dist- Thane-421401, Maharastra. | Water determination | CDTL-Mumbai |
52. | Sodium Polystyrene Sulfonate BP | SC27/048M/ 24 | 07/2024 | 07/2029 | M/s. Phaex Polymers Private Limited Plot No. : F-10, MIDC, | Loss on drying | CDTL-Mumbai |
Murbad, Dist- Thane-421401, Maharastra. | |||||||
53. | Nitrofurantoin Tablets I.P 100 mg | NFDT1201 | 10/2024 | 09/2026 | M/s. Unicure India Ltd., C - 21, 22 & 23, Sector- 3, Noida - 201301, Distt. : Gautam Budh Nagar (U.P.) | Dissolution | CDTL Indore |
54. | Glipizide & Metformin Tablets I.P | Z24-011 | 01/2024 | 12/2026 | M/s. Zee Laboratories Ltd., Behind 47, Industrial Area, Paonta sahib - 173025 | Description | CDTL Indore |
55. | Cefpodoxime Dispersible Tablets 200 mg (Xpocef 200 DT) | XCT24078C | 11/2024 | 10/2026 | M/s.Xperia Creation, Survey No. 915/2, Block PartA, Jetalpur Pirana Road, At & Post.-Girmatha Village, Tal.Daskori, Dist-Ahmedabad382425, Gujarat. | Uniformity of Dispersion | CDTL, Hyderabad |
CDSCO classifies Not of Standard Quality (NSQ) drugs as, “Drugs that fail to meet the quality standards or specifications... as set out in the Second Schedule of the Drugs and Cosmetics Act, 1940.”
Spurious Drug Batches Under Investigation
As per the "List of Spurious Drugs for June 2025", four products were found to be spurious—meaning the drugs bore labels of companies that denied manufacturing the said batches. All four cases are currently under investigation. In all four cases, the CDSCO report confirms, “The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug.”
List of Drugs, Medical Devices, Vaccine and Cosmetics declared as Spurious for the Month of June-2025
S.No. | Name of Drugs/medical device/cosmetics | Batch No. | Date of Manufacture | Date of Expiry | Manufactured By | Reason for failure | Drawn By | Firm’s reply | Remarks |
1. | Cefixime Tablets IP (TAXIM-O 200 TABLETS) | 24460967 | Jul-2024 | Jun-2026 | Under Investigation | Identification and Assay of Cefixime Trihydrate | Drugs Inspector, Bihar | The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. | The product is purported to be spurious, however, the same is subject to outcome of investigation. |
2. | Ointment of Heparin Sodium and Benzyl Nicotinate (THROMBOPHOB) | I404138 | Aug-2024 | Jul-2027 | Under Investigation | Identification and Assay of Heparin Sodium | Drugs Inspector, New Delhi | The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. | The product is purported to be spurious, however, the same is subject to outcome of investigation. |
3. | Rosuvas F 10 Tablets Rosuvastatin and Fenofibrate Tablets IP | SIF2676A | 12-2024 | 05-2027 | Under Investigation | Description and Assay of Fenofibrate | Drugs Inspector, Telangana | The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. | The product is purported to be spurious, however, the same is subject to outcome of investigation. |
4. | Rosuvas F 20 Tablets Rosuvastatin and Fenofibrate Tablets IP | SIF2736A | 12-2024 | 05-2027 | Under Investigation | Assay of Fenofibrate | Drugs Inspector Telangana | The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. | The product is purported to be spurious, however, the same is subject to outcome of investigation. |
a. If it is manufactured under a name which belongs to another drug; or
b. if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or
c. If the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or
d. If it has been substituted wholly or in part by another drug or substance; or
e. If it purports to be the product of a manufacturer of whom it is not truly a product.
(The term “Spurious Drug” has been defined under Section 17-B of the Drugs and Cosmetics Act, 1940).
Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
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