CDSCO Flags 27 Drug Batches Including Paracetamol, Ibuprofen, Levetiracetam as Not of Standard Quality
New Delhi: In a fresh drug quality alert highlighting continued regulatory surveillance, 27 batches of drugs and one medical device have been declared Not of Standard Quality (NSQ) by laboratories functioning under the Central Drugs Standard Control Organisation (CDSCO) for June 2026.
The NSQ list spans a broad range of pharmaceutical products, including tablets, injections, syrups, oral suspensions, capsules, eye/ear drops, ointments, and a disposable syringe, indicating comprehensive quality monitoring across multiple dosage forms and therapeutic categories.
Among the products that failed quality testing were Etodolac Tablets IP manufactured by Pacific India; Adenosine Injection IP 6 mg/2 ml manufactured by Smayan Healthcare Pvt. Ltd. and Welcure Remedies (two batches); Simethicone Drops by Priya Life Science; Paracetamol Paediatric Oral Suspension IP by Skylink Pharma; Phenytoin Sodium Injection USP by Radiant Parenterals Ltd.; Escitalopram Oxalate & Clonazepam Tablets IP by Oxford Pharma; Cyproheptadine Hydrochloride & Tricholine Citrate Syrup by Glorius Pharmaceuticals; Albendazole Tablets IP 400 mg by Mancare Laboratories Pvt. Ltd.; Montelukast Tablets IP by Civron Pharmaceuticals; Levetiracetam Tablets IP 1000 mg by Astonea Labs Limited; Calcium & Vitamin D3 Tablets IP by Sunlife Sciences; Pantoprazole Gastro-resistant Tablets IP by Athens Life Sciences; Atorvastatin Tablets IP 20 mg by Hindustan Antibiotics Ltd.; Povidone-Iodine Ointment USP 5% w/w by Hindustan Laboratories Limited and others.
Also Read: State Drug Alert: 111 Batches Including Paracetamol, Telmisartan Fail CDSCO Quality Tests
Further, the list also includes Noscapine, Sodium Citrate & Ammonium Chloride Oral Suspension manufactured by Biological E. Limited and Trypsin-Chymotrypsin Tablets manufactured by Torrent Pharmaceuticals Ltd.
The NSQ list also features a Disposable Syringe for Single Use Only manufactured by Sterisafe Health Solutions, which was declared Not of Standard Quality after failing the sterility test.
The quality deficiencies identified were varied and significant, including dissolution failures affecting drug release, assay failures indicating incorrect active ingredient content, sterility failures, bacterial endotoxin contamination, microbial contamination, particulate matter, pH deviations, identification failures, related substance and impurity issues, description non-compliance, hardness and friability defects, alcohol content deviations, and inadequate enzymatic activity.
Notably, one batch of Adenosine Injection IP manufactured by Welcure Remedies was also declared spurious under Section 17B of the Drugs and Cosmetics Act, 1940, after failing multiple critical quality parameters including identification, sterility, particulate matter and assay.
| 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 | Etodolac Tablets IP | PNT5-1754A | Pacific India,Village Dhana (Bagh Bania) Tehsil Nalagarh, District Solan H.P. | The sample received does not conform to i.p.2022 specification with respect to the test for Dissolution | CDSCO Labs | CDTL-Hyderabad | JUN-2026 | ||
| 2 | Adenosine Injection IP 6 mg/2ml | I5K048 | Smayan Healthcare Pvt. Ltd.,Plot No. 8-9-26-27, HPSIDC Ind. Area, Vill. Davni, Baddi, Distt. Solan (H.P.)-173205 | The sample does not conforms to I.P. 2022 with respect to the test for pH | CDSCO Labs | CDTL, Mumbai | JUN-2026 | ||
| 3 | Simethicone Drops 30ml | EH25057 | Priya Life Science,174-A, 175, Siddhi Industrial Infrastructure Park, Opp. Waghodia GIDC, Waghodia Vadodara- 391760 | The sample does not conform to Manufacturers specification with respect to test for pH and Assay. | CDSCO Labs | CDTL, Mumbai | JUN-2026 | ||
| 4 | Adenosine Injection IP 6 mg/2ml | WADG25002A | Welcure Remedies,,Nahan Road, Village Moginand, Kala Amb, District Sirmour, Himachal Pradesh -173030 | The sample is not of standard quality as per I.P. 2022 with respect to the Test for Identification, Particulate matter, Sterility, Bacterial endotoxins, Assay/content of Adenosine and is also not of standard quality for the reasons stated under Description | CDSCO Labs | CDTL, Mumbai | JUN-2026 | ||
| 5 | Paracetamol Paediatric Oral Suspension IP 250mg, 60ml | SL25156 | Skylink Pharma,Survey No. 413 , Indrad, Near Hitachi, Chhatral Kadi Road, Tal. Kadi, District Mehsana-382715, Gujarat, India | The sample does not conform to as per I.P. 2022 with respect to the test of Microbial contamination (Total aerobic viable count). | CDSCO Labs | CDTL, Mumbai | JUN-2026 | ||
| 6 | Adenosine Injection IP 6 mg/2ml | WADG25001A | Welcure Remedies,Nahan Road, Vill. Moginand, Kala-Amb, Distt. Sirmour (H.P.) 173030 | The sample does not conforms to I.P. 2022 with respect to the Test of Identification, Particulate matter, Sterility, Bacterial endotoxins and Assay. The sample is deemed spurious as per D and C Act section 17 (B). | CDSCO Labs | CDTL, Mumbai | JUN-2026 | ||
| 7 | Phenytoin Sodium Injection USP 2ml | 33P25002 | Radiant Parenterals Ltd.,242/4,5 & 6, G.I.D.C. Estate at & Post Waghodia, Dist- Vadodara, Gujarat- 391760 | The sample does not conform to U.S.P. 48 with respect to the Test for Alcohol and Propylene Glycol content ( Alcohol content) | CDSCO Labs | CDTL, Mumbai | JUN-2026 | ||
| 8 | Escitalopram Oxalate & Clonazepam Tablets IP | NT250199 | Oxford Pharma,Khasra No. 913, Puhana Chowk, Dehradun Road, Roorkee, Distt. Haridwar, Uttarakhand 247667 | The sample does not conform to the I.P. with respect to test for Related Substance and Description. | CDSCO Labs | CDL Kolkata | JUN-2026 | ||
| 9 | Cyproheptadine Hydrochloride & Tricholine Citrate Syrup | ZL-021 | Glorius Pharmaceuticals,Mainpura, Danapur, Cantt , Patna-801503 | The sample does not conform to claim with respect to the test for Assay of Cyproheptadine Hydrochloride and Tricholine Citrate, and Description. | CDSCO Labs | CDL Kolkata | JUN-2026 | ||
| 10 | B-Complex with L-Lysine & Zinc Syrup | BL-2650 | Bioland Pharma,Plot No. 145, Industrial Estate, HSIIDC, Saha-133104 (AMBALA) Haryana | The sample does not conform to claim as per Schedule V of Drugs and Cosmetics Act and Rules 1945 with respect to Assay of Zinc, Vitamin B3, Vitamin B1, Vitamin B2, Vitamin B6 and Vitamin D3. | CDSCO Labs | CDL Kolkata | JUN-2026 | ||
| 11 | Noscapine, Sodium Citrate, Ammonium Chloride Oral Suspension | D3801625 | Biological E. Limited,Plot No. 31 & 32, Pharma City, Selaqui, Dehradun-248 011, Uttarakhand | The sample does not conform to Manufacturer's specification with respect to Assay of Noscapine. | CDSCO Labs | CDL Kolkata | JUN-2026 | ||
| 12 | Albendazole Tablets IP 400 mg | MT250979 | Mancare Laboratories Pvt. Ltd.,Plot No. 11, Pharmacity, Selaqui, Dehradun, Uttarkhand-248011 | The sample does not conform to IP with respect to test for Dissolution and Assay of Albendazole | CDSCO Labs | CDL Kolkata | JUN-2026 | ||
| 13 | Montelukast Tablets I.P. | CRT-250217 | Civron Pharmaceuticals,13 Industrial Area Phase III Sansarpur Terrace Dist Khangra Himachal Pradesh 176501 | The sample is found to be Not of Standard Quality for the reason stated under Description. | CDSCO Labs | CDL Kolkata | JUN-2026 | ||
| 14 | Levetiracetam Tablets IP 1000mg | ADT251795 | Astonea Labs Limited,Vill-Haripur, Teh-Raipur Rani, Distt-Panchkula, Haryana, INDIA-134204 | The sample is found Not of Standard Quality for the reason stated under Description as per Schedule V of Drugs and Cosmetic Acts and Rules. | CDSCO Labs | CDL Kolkata | JUN-2026 | ||
| 15 | Levosalbutamol Sulphate, Ambroxol HCl & Guaiphenesin Syrup 60 ml | SD-1376C | Sano-Cito Therapeutics Inc.,Vill. Loharan, P.O. Ghatti, Solan-173211 (H.P.). | The sample does not conform to claim as per Schedule V of Drugs and Cosmetic Acts and Rules 1945 with respect to Assay/content of Levosalbutamol sulphate Equivalent to Levosalbutamol. | CDSCO Labs | CDL Kolkata | JUN-2026 | ||
| 16 | Trypsin-Chymotrypsin Tablets | 2KU6M021 | Torrent Pharmaceuticals Ltd,,32 No. Middle Camp, Nh-10, East District, Gangtok, Sikkim-737 135. | The sample does not conform to Manufacturer's specification with respect to Assay of Trypsin-Chymotrypsin activity. | CDSCO Labs | CDL Kolkata | JUN-2026 | ||
| 17 | Gentamicin Eye/Ear Drops 5 ml | 1224-226 | Zee Laboratories Ltd.,Behind 47, Industrial Area, Paonta Sahib-173025 | The sample does not conform to Manufacturer's specification with respect to test for Particulate Matter | CDSCO Labs | CDL Kolkata | JUN-2026 | ||
| 18 | Deferasirox Dispersible Tablets 100mg | DFA03G25 | Bajaj Healthcare Ltd,R.S. No. 1818, Manjusar-Savli Road, At & Post -Manjuasar, Tal. Savli, Dist. Vadodara-391775, Gujarat, India | The sample is declared to be not of standard quality for the reason stated under Description and as it does not conform to Manufacturer's Specification with respect to the tests of Hardness and Friability. | CDSCO Labs | CDL Kolkata | JUN-2026 | ||
| 19 | Lenvatinib Capsules IP 4 mg | ACC2502LV | Aprazer Healthcare Pvt. Ltd.,Vill. Kotla, Barotiwala - 174 103 Distt: Solan, Himachal Pradesh | The sample does not conform toI.P. with respect to the test for Identification Lenvatinib mesylate eq. to Lenvatinib. | CDSCO Labs | CDL Kolkata | JUN-2026 | ||
| 20 | Calcium & Vitamin D3 Tablets IP | T-250024 | Sunlife Sciences,130, Kurdi, Jabrera Road, Manglour, Roorkee, Distt. Haridwar (U.K) | The sample does not conform to claim as per I.P. 2022 with respect to the test for Assay of Vitamin D3. | CDSCO Labs | RDTL, Guwahati | JUN-2026 | ||
| 21 | Ibuprofen Tablets IP 400 mg | IBK-2503 | Askon Health Care,11-B, Industrial Area, Maxi Road,Ujjain-456010(M.P.) | The sample does not comply as per I.P. 2022 with respect to the test for Dissolution of Ibuprofen. | CDSCO Labs | RDTL, Guwahati | JUN-2026 | ||
| 22 | Pantoprazole Gastro-resistant Tablets IP | TG25-03290 | Athens Life Sciences,Mauza Rampur, Jattan, Nahan Road, Kala Amb, Distt. Sirmour, H.P.-173030 | The sample does not comply as per I.P. 2022 with respect to the test for Dissolution in Acid Stage for Pantoprazole and Description. | CDSCO Labs | RDTL, Guwahati | JUN-2026 | ||
| 23 | Bromhexine Hydrochloride, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup | L-2601029 | Rivpra Formulation Pvt. Ltd.,Plot No.8, Sector-6A, I.I.E. SIDCUL, Haridwar-249 403 (U.K.) | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Bromhexine Hydrochloride. | CDSCO Labs | RDTL, Chandigarh | JUN-2026 | ||
| 24 | Atorvastatin Tablets IP 20mg | 0062 | Hindustan Antibiotics Ltd,(A Govt. of India Enterprise) Pimpri, Pune - 411 018, INDIA. | The sample does not conform to claim as per IP 2022 in respect to test of Related substances. | CDSCO Labs | RDTL, Chandigarh | JUN-2026 | ||
| 25 | Povidone-Iodine Ointment USP 5% w/w | EP25081AL | Hindustan Laboratories Limited,Plot No. 5-9, 1, Survey No. 38/2, Aliyali, Palghar (W), Dist - Palghar 401404 (M.S.) | The sample does not conform to claim as per USP 2025 in respect to the Assay of Povidone-Iodine as Available Iodine | CDSCO Labs | RDTL, Chandigarh | JUN-2026 | ||
| 26 | Esomeprazole Magnesium Tablets IP 40mg | VGT250168 | Vapi Care Pharma Pvt. Ltd.,Plot No.225/3, Near Morarji Circle, Gidc Vapi, Dist.Valsad-396195 Gujarat | The 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 | JUN-2026 | ||
| 27 | Disposable Syringe For Single Use Only | 052502GX01 | Sterisafe Health Solutions,120-121, Industrial Area, Near Bhawani Dharam Kanta, Bapi- 303507 R.J | The sample does not comply as per IP 2022 with respect to the test for Sterility. | CDSCO Labs | RDTL, Guwahati | JUN-2026 |
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.