29 Drug Batches, Including Haloperidol, Amikacin, Rabeprazole Fail CDSCO Quality Tests
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has listed 29 batches of drugs, surgical products, and a pharmaceutical ingredient as Not of Standard Quality (NSQ) in its central drug laboratory report for August 2026.
The findings cover injectables, antibiotics, cardiovascular medicines, antifungal capsules, cough preparations, and dressings.
Several injectable products failed sterility or bacterial endotoxin tests. These include Bupivacaine Hydrochloride in Dextrose Injection manufactured by Themis Medicare, Haloperidol Injection manufactured by Tamman Titoe Pharma, Compound Sodium Lactate Injection manufactured by Paschim Banga Pharmaceutical, and Glycopyrrolate Injection manufactured by Jackson Laboratories. The compound sodium lactate sample also failed the particulate contamination test.
Other injectable products were flagged for different reasons. A Dexamethasone Sodium Phosphate Injection batch manufactured by Cotec Healthcare failed tests including particulate matter and assay. A Rabeprazole Sodium Injection batch manufactured by Martin & Brown Bio-Sciences failed multiple tests, including clarity of solution, particulate matter, pH, related substances and assay.
The list also includes Amoxicillin and Potassium Clavulanate Tablets manufactured by Brooks Laboratories, which failed the dissolution test for amoxycillin; Rabeprazole Sodium Tablets manufactured by Intas Pharmaceuticals, which failed the buffer-stage dissolution test; and Clopidogrel Tablets manufactured by Bactolac Formulation, which failed dissolution testing. Two batches of Itraconazole Capsules, made by Kivi Labs and Azot Life Sciences, were also flagged for dissolution failures.
Drugs and healthcare products that fail to meet prescribed quality standards are categorized as Not of Standard Quality (NSQ). Under Section 16(1)(a) of the Drugs and Cosmetics Act, 1940, a drug is required to comply with the standards specified under the Act and the relevant pharmacopoeial requirements. Failure to meet these standards can result in regulatory action, including product recalls, investigations, and legal proceedings against manufacturers where warranted.
| 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 | Sodium Chloride And Dextrose Injection I.P. (0.9% w/v & 5% w/v) | P260553007 | May-2026 | Apr-2029 | Vision Parenteral Pvt. Ltd.,A-2-44,45 Sector- 15, GIDA Industrial Area Gorakhpur- 273209 (U.P.) India. | The sample does not conform to IP with respect to Extractable Volume. | CDSCO Labs | CDL, Kolkata | AUG-2026 |
| 2 | Rolled Bandage | AE-RB6-10-2K25-03 | Mar-2025 | Feb-2028 | Arunachala Enterprises ,D.no. 23-4B/278 To 285, Vasavi Pharma Market Complex 4th Floor, Opp Ayyappa Swamy Temple, Gollapudi, Vijayawada 521225, AP | The sample does not conform to Schedule F(II) with respect to length. | CDSCO Labs | CDL, Kolkata | AUG-2026 |
| 3 | Absorbent Cotton Wool IP | 433 | Nov-2023 | Oct-2026 | Siva Sivani Surgical Cottons(P) Ltd. ,Fac: S.No. 11/3, Kovvur Road, Kakinada | The sample does not conform to I.P. with respect to Surface active substances and water soluble substances. | CDSCO Labs | CDL, Kolkata | AUG-2026 |
| 4 | Choline Theophyllinate 50mg & Terbutaline Sulphate 1.25 mg Syrup | KPD-2502 | Oct-2025 | Sep-2027 | Aries Drugs Pvt. Ltd. ,Plot No.90, Sector-IIDC, IIE, SIDCUL, Pantnagar, Distt- U.S. Nagar, Uttarakhand-263153 | The sample does not conform to Manufacturer's specification with respect to Assay of Terbutaline Sulphate. | CDSCO Labs | CDL, Kolkata | AUG-2026 |
| 5 | Bupivacaine Hydrochloride In Dextrose Injection USP | BKBP02601 | May-2026 | Apr-2028 | Themis Medicare Ltd. ,11/12, Udyog Nagar, S. V. Road, Goregaon West, Mumbai PIN 400104. At: Gat No: 218, Near Katwad Fata, Village: Telegaon , Tal: Dindori, Nashik-422004 | The sample does not conform to USP with respect to the test for pH and Bacterial Endotoxin. | CDSCO Labs | CDL, Kolkata | AUG-2026 |
| 6 | Calcitriol, Calcium Carbonate, Zinc, Magnesium, Vitamin K2-7, Methylcobalamin & L- Methyl Folate Soft Gelatin Capsules | CD-252145B | Oct-2025 | Sep-2027 | Capsoft Healthcare Pvt. Ltd. ,Shed No.6, Khasra No.760-761, Khalsa Complex, Village Karuana, Sai Road, Baddi, Solan-173205 (H.P) | The sample does not conform to claim with respect to the Assay of Elemental Zinc, Methylcobalamin and L-Methylfolate. | CDSCO Labs | CDL, Kolkata | AUG-2026 |
| 7 | Dexamethasone Sodium Phosphate Injection IP | CHI-60004 | Jan-2026 | Dec-2027 | Cotec Healthcare Ltd. Kh. No. 593/1, Roorkee- Dehradun Highway, Kishanpur, Roorkee- 247667(Uttarakhand) India. | The sample does not conform to IP with respect to the tests for'Particulate matter and Assay of Dexamethasone Sodium Phosphate eq. to Dexamethasone Phosphate and is also not of standard quality for the reason stated under Description. | CDSCO Labs | CDL, Kolkata | AUG-2026 |
| 8 | Azithromycin & Lactic Acid Bacillus Tablets | GT30389J | Dec-2025 | Nov-2027 | J.M.Laboratories.,Village-Bhanat, PO - Ghatti, Subathu Road, Solan (HP) 173211 | The sample does not conform to claim as per Schedule V of Drug and Cosmetics Act and Rules 1945 with respect to Assay of Lactic Acid Bacillus. | CDSCO Labs | CDL, Kolkata | AUG-2026 |
| 9 | Aceclofenac 100mg, Serratiopeptidase 15mg & Paracetamol 325mg Tablets | FND0725001BH | Jan-2025 | Jun-2027 | Ipca Laboratories Ltd. ,393/394, Melli Jorethang Road, Gom Block, Bharikhola, South District, Sikkim 737 121 | The sample does not conform to claim with respect to Identification and Assay/content of Aceclofenac, Paracetamol and Serratiopeptidase activity. | CDSCO Labs | CDL, Kolkata | AUG-2026 |
| 10 | Itraconazole Capsules IP 200 mg | 02T65 | Dec-2025 | Nov-2027 | Kivi Labs Ltd. ,147-148, GIDC, Por-Ramangamdi, Dist. Baroda-391243, Gujarat. | The sample does not conform to I.P. with respect to the Dissolution test. | CDSCO Labs | CDL, Kolkata | AUG-2026 |
| 11 | Rabeprazole Sodium Injection IP | MD25A16 | Jan-2025 | Dec-2026 | Martin & Brown Bio-Sciences Pvt. Ltd. ,K.No 918/419, Malkumajra, Nalagarh Road, Baddi, Distt. Solan (H.P.) 173205 | The sample does not conform to I.P. with respect the tests of Description, Clarity of solution, Particulate matter, pH, Related substances and Assay of Rabeprazole Sodium. | CDSCO Labs | CDL, Kolkata | AUG-2026 |
| 12 | Bupivacaine Hydrochloride in Dextrose Injection USP 4ml | BD25G2 | Aug-2025 | Jul-2027 | Arco Lifesciences (I) Pvt. Ltd. ,C-86, M.I.D.C., Hingna, Nagpur-16 | The sample does not conform to U.S.P. with respect to Assay of Dextrose Anhydrous | CDSCO Labs | CDL, Kolkata | AUG-2026 |
| 13 | Amikacin Sulphate Injection IP | UGL-24375A | Oct-2024 | Sep-2026 | Ultra Drugs Pvt. Ltd. ,Plot No. 1315-1318, VPO Manpura, Baddi-Nalagarh Road, Distt. Solan (H.P.) 174101. | The sample does not conform to I.P. with respect to test for ' Particulate Matter' and is also not of standard quality for the reason stated under Description | CDSCO Labs | CDL, Kolkata | AUG-2026 |
| 14 | Itraconazole Capsules IP | AC-662H | Nov-2025 | Oct-2027 | Azot Life Sciences,Vill. Chewa, P.O. Kumarhatti, Distt. Solan-173229 (H.P.) | The sample does not conform to I.P. with respect to test for Dissolution. | CDSCO Labs | CDL, Kolkata | AUG-2026 |
| 15 | Haloperidol Injection I.P. | HP404 | May-2024 | Apr-2027 | Tamman Titoe Pharma Pvt. Ltd. ,56-57, SIDCO Pharmaceuticals Complex, Alathur 603110, Tamilnadu | The sample does not comply as per I.P. 2022 with respect to the test for Sterility. | CDSCO Labs | RDTL, Guwahati | AUG-2026 |
| 16 | Compound Sodium Lactate Injection I.P. | 03BF2457 | Mar-2024 | Feb-2027 | Paschim Banga Pharmaceutical (A Unit Of Farista Vanijya Pvt. Ltd.),NH-31, Tin Mile Hat, Sonapur Hat, P.S.-Chopra, Dist Uttar Dinajpur, Pin 733 214 (W.B.) | The sample does not comply as per I.P. 2022 with respect to the test for Sterility and Particulate Contamination. | CDSCO Labs | RDTL, Guwahati | AUG-2026 |
| 17 | Cefpodoxime Proxetil Dispersible Tablets | CT25005B | Jan-2025 | Dec-2026 | Alps Communication Pvt. Ltd.,Village - Johron, Trilokpur Road, Kala Amb, Distt. Sirmour - 173 030, (H.P.) INDIA. | The sample is not of standard quality for the reason stated under Description of the tablets. | CDSCO Labs | RDTL, Guwahati | AUG-2026 |
| 18 | Prednisolone Tablets IP | PRD2516 | Dec-2025 | Nov-2027 | Concord Drugs Ltd. ,Survey No.: 249,Brahmanapally , R.R. Dist., Telangana-501511 | The sample is not of standard quality for the reason stated under Description of the tablets. | CDSCO Labs | RDTL, Guwahati | AUG-2026 |
| 19 | Levocetirizine Hydrochloride and Montelukast Tablets | 41046 | Nov-2025 | Oct-2027 | Ronak Life Care Pvt. Ltd. ,R.S. No. 41 (Part), At & Post Rajpur, Dist Patan-384265 | The sample does not comply as per I.P. 2022 with respect to the test for Dissolution of Montelukast. | CDSCO Labs | RDTL, Guwahati | AUG-2026 |
| 20 | Dextromethorphan Hydrobromide Phenylephrine Hydrochloride and Chlorpheniramine Maleate Syrup, | JLJ2523 | Oct-2025 | Sep-2027 | Janveda Healthceutical Pvt. Ltd. ,26, Gopi Estate Changodar, Ahmedabad-382213 (Gujrat) | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Phenylephrine Hydrochloride | CDSCO Labs | RDTL, Chandigarh | AUG-2026 |
| 21 | Amoxicillin And Potassium Clavulanate Tablets IP | GBR1240 | Jun-2026 | May-2028 | Brooks Laboratories Ltd., At : Vill. Kishanpura, Nalagarh Road, Baddi, (H.P.) - 174 101. | The sample does not conform to claim as per IP 2022 in respect to the Test of Dissolution of Amoxycillin. | CDSCO Labs | RDTL, Chandigarh | AUG-2026 |
| 22 | Rabeprazole Sodium Tablets IP 20 mg | N2600742 | Mar-2026 | Feb-2028 | Intas Pharmaceuticals Ltd.,Samardung Road, Kabrey Block, Namthang Elaka, South Sikkim-737132, INDIA. | 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 | AUG-2026 |
| 23 | Rabeprazole Sodium Gastro Resistant and Domperidone Prolonged Release Capsules | 2604209 | Apr-2026 | Mar-2028 | Sai Sarvaa Biotech Pvt. Ltd.,Plot No. 8 & 9, Balaji Nagar, Pattanur, Auroville (Po), Vanur (TK), Villupuram (Dt.) Pin - 605 101. | The sample does not conform to claim as per Patent and Proprietary in respect to the Test of Dissolution of Domperidone (12th hours), Dissolution of Rabeprazole Sodium (buffer stage). | CDSCO Labs | RDTL, Chandigarh | AUG-2026 |
| 24 | Sodium Bicarbonate Tablets USP 1000 mg | T-2502219 | Feb-2025 | Jan-2027 | Rivpra Formulation Pvt. Ltd, Plot No. 8, Sector-6A, I.I.E., SIDCUL, Haridwar-249 403 (Uttarakhand), INDIA | The sample does not conform to claim as per USP 2025 in respect to the Test of Description. | CDSCO Labs | RDTL, Chandigarh | AUG-2026 |
| 25 | Clopidogrel Tablets IP | BCGT25016 | May-2025 | Apr-2027 | Bactolac Formulation Pvt. Ltd.,Plot No. 70 (part) , TSIIC-IALA, Phase-I, Cherlapally Village, Kapra Mandal, Medchal-Malkajgiri District, Telangana-500051, INDIA | The sample does not conform to claim as per IP 2022 in respect to the Test of Dissolution | CDSCO Labs | RDTL, Chandigarh | AUG-2026 |
| 26 | Salicylic Acid & Benzoic Acid Antiseptic Powder 150mg | 4226D025 | Apr-2026 | Sep-2028 | Khushboo Beauty Care,Survey No. 69/4/2, Village Athal, Silvassa-396230, Dadra And Nagar Haveli | The sample received does not conform to Manufacturers specification with respect to the test for Microbial limit test, Total aerobic microbial count, Total combined yeasts and moulds count. | CDSCO Labs | CDTL, Mumbai | AUG-2026 |
| 27 | Glycopyrrolate Injection IP 0.2 mg/ml | I-7981 | Dec-2025 | Nov-2027 | Jackson Laboratories Pvt.Ltd. ,22-24, Majitha Road, Bye Pass, Amritsar-143 001(India) | The sample received does not conform to IP 2022 specification with respect to the test for sterility only | CDSCO Labs | CDTL, Hyderabad | AUG-2026 |
| 28 | Losartan Potassium USP | LOP0110526II | May-2026 | Apr-2031 | Synergene Active Ingredients Pvt. Ltd., Unit-II,,Plot No.59D, JNPC, Parawada (V), Parawada (M), Anakapalli-531021, A. P. India. | The sample does not conform to USP with respect to the test of Water Determination. | CDSCO Labs | CDTL, Indore | AUG-2026 |
| 29 | Vildagliptin Tablets I.P. 50 mg | VFGT1214 | Mar-2025 | Feb-2027 | Unicure India Ltd. ,C-21, 22 & 23, Sector-3, Noida-201301, Distt. Gautam Budh Nagar (U.P) | The sample does not conform to I.P with respect to the test for Assay of Vildagliptin | CDSCO Labs | CDTL, Indore | AUG-2026 |
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