Ingredient record · Opioid used for pain and addiction treatment
Buprenorphine: bans, restrictions and failed batches in India
Last checked 3 November 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Sep 2026
No combination containing Buprenorphine is on India's banned-drugs list. 28 batches of medicines containing Buprenorphine failed a government lab test between May 2022 and September 2026, from 12 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
0
Banned combinations in force
0
Other listed orders (stayed, restricted, quashed)
28
Batches failed a lab test
Sep 2026
Latest lab alert
On the banned-drugs list
Buprenorphine on its own is not on CDSCO's banned list. The entries below are specific combinations that contain it. Status follows CDSCO's own notes on each entry.
No entry containing Buprenorphine is on the list compiled from CDSCO's Section 26A notifications (1983 to 2026). That is not a statement that every product containing it is safe.
Products that failed lab tests
Product names as printed by the testing labs, grouped. Open a product to see every batch number.
| Product | Batches | Makers | Latest |
|---|---|---|---|
| Buprenorphine | 15 | 6 | Sep 2026 |
| Buprenorphine Naloxone Sublingual | 10 | 5 | Sep 2026 |
| Buprenorphine Hci Naloxone Sublingula | 1 | 1 | Sep 2026 |
| Buprenorphine Nalaxone | 1 | 1 | Oct 2025 |
| Lupigesic Buprenorphine | 1 | 1 | Sep 2025 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Buprenorphine and Naloxone sublingual Tablets I.P. 2mg+ 0.5mg | Batch SLTF26030Mfg Jun 2026 · Exp May 2028 | Swift Life Sciences Pvt. LtdUttarakhand | 1. The content of Buprenorphine found to be 1.74 mg per tablet (87%) against labelled claim of 2.0 mg per tablet. 2. The content of Naloxone found to be 0.432 mg per tablet (86.40%) against labelled claim of 0.5 mg per tablet.Labelling | SDTL, PunjabState lab | Sep 2026 |
| Buprenorphine Injection IP 2 ml | Batch BUP324004Mfg Feb 2025 · Exp Jan 2027 | Indus Pharma Pharma Pvt. LtdRajasthan | The sample does not conform to I.P. in respect of Identification & Particulate matter, hence SpuriousIdentification | LUCKNOW, Uttar PradeshState lab | Sep 2026 |
| Buprenorphine HCI and Naloxone Sublingula Tablets I.P. | Batch SLTE26026Mfg May 2026 · Exp Apr 2028 | Swift Life Sciences Pvt. LtdUttarakhand | The content of Buprenorphine found to be 0.451 mg per tablet (112.75%) against labelled claim of 0.4 mg per tabletLabelling | SDTL, PunjabState lab | Sep 2026 |
| Buprenorphine Injection IP. 2ml | Batch BUP324040Mfg Dec 2024 · Exp Jul 2026 | 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 |
| Buprenorphine 2 mg and Naloxone 0.5 mg Sublingual Tablets IP | Batch 25CT0314Mfg Mar 2025 · Exp Feb 2027 | Consern Pharna LtdPunjab | The sample is of not of standard quality for the reason stated under DescriptionDescription | RDTL,GuwahatiState lab | Jul 2026 |
| Buprenorphine 2 mg and Naloxone 0.5 mg Sublingual Tablets I.P. | Batch 25CT0314Mfg Mar 2025 · Exp Feb 2027 | Consern Pharma LimitedPunjab | The sample is not of standard quality for the reason stated under Description of the tablets.Description | RDTL, GuwahatiCDSCO lab | Jul 2026 |
| Buprenorphine Injection IP 2ml | Batch BUP325007Mfg Sep 2025 · Exp Aug 2027 | 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 |
| Buprenorphine Injection IP | Batch ASG1590Mfg Nov 2022 · Exp Oct 2026 | 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 |
| Buprenorphine Injection IP 0.3ml | Batch AMB25003Mfg Aug 2025 · Exp Jul 2027 | Farbe Firma Pvt. LtdGujarat | The sample does not conform to I.P. with respect to the Test of pHpH | CDL, KolkataCDSCO lab | Mar 2026 |
| Buprenorphine Injection IP 2ml | Batch 1364 ASOMfg Jun 2025 · Exp May 2028 | 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 |
| Buprenorphine Injection IP 2ml | Batch 1364 ASOMfg May 2024 · Exp Apr 2026 | 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 |
| Buprenorphine Injection IP 2ml | Batch BUP325004Mfg Apr 2025 · Exp Mar 2027 | 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 |
| Buprenorphine Injection IP 2ml | Batch BUP325004Mfg Apr 2025 · Exp Mar 2027 | 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 |
| Buprenorphine Injection IP 2ml | Batch BUP325005Mfg May 2025 · Exp Apr 2027 | 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 |
| Buprenorphine and Naloxone Sublingual Tablets IP (Adnomore-N) | Batch ADN5001Mfg Apr 2025 · Exp Feb 2028 | Ethicare Pharmaceuticals (P) LtdGujarat | ContentOther | SDTL, PunjabState lab | Oct 2025 |
Showing 15 of 28 records
Holding a strip or bottle? The batch number is printed after "B. No." Check it against every alert. If it matches, return it to the pharmacy. What the labels mean: status guide.