Product record

Buprenorphine: batches declared Not of Standard Quality

Last checked 20 September 2026. Source: CDSCO monthly NSQ alerts, Jan 2019, Jul 2026

14 batches of products named "Buprenorphine" (as printed by the testing lab) failed a CDSCO or state drug-testing laboratory test between May 2022 and July 2026. This is a record of specific batches, it does not mean the molecule or every brand is unsafe.

Records by type

14 records linked to Buprenorphine in the datasets we hold. A zero means nothing is on record in those datasets, not that nothing ever happened. What the labels mean.

0Banned or prohibited
0Recalled or suspended
14Failed a lab test
0Regulatory notice
Primary government sourceTier 1: government primary source

CDSCO drug alerts: Not of Standard Quality and spurious drugs

CDSCO · CDSCO monthly NSQ alerts, May 2022 to Jul 2026

View original document

Scope. A failed batch is not a verdict on every pack of this product. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.

14
NSQ batches
5
Manufacturers
Assay
Most common reason
Jul 2026
Latest alert

Flagged batches

Batch Manufacturer Reason declared NSQ Tested by Alert
BUP324040Mfg 2024-12 · Exp 2026-07 Indus Pharma Pvt. LtdRajasthan The sample does not conform to I.P. with respect to tests of Particulate matter and Assay of Buprenorphine.Assay CDL, KolkataCDSCO lab Jul 2026
BUP325007Mfg 2025-09 · Exp 2027-08 Indus Pharma Pvt. LtdRajasthan The sample does not conform to I.P. with respect to the test of Particulate Matter and for the reason stated under Description.Description CDL, KolkataCDSCO lab Apr 2026
ASG1590Mfg 2022-11 · Exp 2026-10 SNG Pharmaceuticals (p) Ltd The sample does not conform to I.P. with respect to tests of Sterility and Assay of Buprenorphine.Assay CDL, KolkataCDSCO lab Apr 2026
AMB25003Mfg 2025-08 · Exp 2027-07 Farbe Firma Pvt. LtdGujarat The sample does not conform to I.P. with respect to the Test of pHpH CDL, KolkataCDSCO lab Mar 2026
1364 ASOMfg 2025-06 · Exp 2028-05 SNG Pharmaceuticals(P) LtdGujarat The sample does not conform to IP with respect to test for Sterility, Related Substances, Particulate matter, Assay of Buprenorphine Hydrochloride and Description.Assay CDL, KolkataCDSCO lab Jan 2026
1364 ASOMfg 2024-05 · Exp 2026-04 SNG Pharmaceuticals(P) Ltd The sample does not conform to IP with respect to test for pH, Related Substance, Particulate matter and Assay of Buprenorphine Hydrochloride.Assay CDL, KolkataCDSCO lab Jan 2026
BUP325004Mfg 2025-04 · Exp 2027-03 Indus Pharma Pvt.LtdRajasthan The sample does not conform to I.P. with respect to the Tests of Extractable volume, Particulate matter and for the reason stated under Description.Description CDL, KolkataCDSCO lab Jan 2026
BUP325004Mfg 2025-04 · Exp 2027-03 Indus Pharma Pvt. LtdRajasthan The sample does not conform I.P. with respect to the Test of Particulate matter and for the reason stated under Description.Description CDL, KolkataCDSCO lab Jan 2026
BUP325005Mfg 2025-05 · Exp 2027-04 Indus Pharma Pvt.LtdRajasthan The sample does not conform to I.P. with respect to the Tests of Particulate matter, Extractable volume and Description.Description CDL, KolkataCDSCO lab Jan 2026
BUP324002Mfg 2024-06 · Exp 2026-05 Indus Pharma Pvt. LtdRajasthan Spurious Identification and Assay of Buprenorphine Hydrochloride, Particulate matter and DescriptionAssay CDL, KolkataCDSCO lab May 2025
1470 ASGMfg 2024-01 · Exp 2025-12 S.M.G. PHARMACEUTICALS (Pvt) LtdGujarat Assay" of BuprenorphineAssay RDTL GuwahatiCDSCO lab Oct 2024
1470 ASGMfg 2023-09 · Exp 2025-08 S.M.G. PHARMACEUTICALS (Pvt) Ltd Assay/Content of BuprenorphineAssay RDTL GuwahatiCDSCO lab Oct 2024
LM 18870Mfg 2020-12 · Exp 2026-11 Cooper Pharma LtdUttarakhand AssayAssay RDTL GuwahatiState lab May 2022
LM 18730Mfg 2018-08 · Exp 2024-07 Cooper Pharma LtdUttarakhand AssayAssay RDTL GuwahatiState lab May 2022

How to use this. Match the batch number on your strip or bottle against the list. If your batch is listed, return it to the pharmacy and ask for a replacement; if not, the product is not on any alert as of July 2026. Check any batch number.