Ingredient record · Local anaesthetic injection
Bupivacaine: 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 Bupivacaine is on India's banned-drugs list. 25 batches of medicines containing Bupivacaine failed a government lab test between June 2021 and September 2026, from 17 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)
25
Batches failed a lab test
Sep 2026
Latest lab alert
On the banned-drugs list
Bupivacaine 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 Bupivacaine 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 |
|---|---|---|---|
| Bupivacaine Hydrochloride in Dextrose | 15 | 12 | Sep 2026 |
| Bupivacaine | 4 | 2 | Sep 2026 |
| Bupivacaine Hydrochloride | 2 | 2 | Apr 2025 |
| Bupivacaine Hydrochlori De | 1 | 1 | Dec 2024 |
| Bupivacaine Hydrochloride in Dextrose Amp | 1 | 1 | Apr 2024 |
| Bupivacaine Heavy | 1 | 1 | May 2023 |
| Bupicain Heavy | 1 | 1 | Nov 2022 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Bupivacaine Injection IP 0.5% | Batch SP26013Mfg Mar 2026 · Exp Feb 2028 | Shukra Pharmaceuticals LtdGujarat | The sample does not conform to IP with respect to test for 'Particulate matter and is also not of standard quality for the reason stated under 'Description'.Description | CDL, KolkataCDSCO lab | Sep 2026 |
| Bupivacaine Hydrochloride in Dextrose Injection USP | Batch MN24369AMfg Mar 2025 · Exp Feb 2027 | Medizia BiotechHimachal Pradesh | The sample does not conform to U.S.P. with respect to test for 'pH', 'Visible Particulates In Injection' and is also not of standard quality for the reason stated under 'Description'.Description | CDL, KolkataCDSCO lab | Sep 2026 |
| Bupivacaine Hydrochloride in Dextrose Injection USP 4ml | Batch BD25G2Mfg Aug 2025 · Exp Jul 2027 | Arco Lifesciences (I) Pvt. LtdMaharashtra | The sample does not conform to U.S.P. with respect to Assay of Dextrose AnhydrousAssay | CDL, KolkataCDSCO lab | Aug 2026 |
| Bupivacaine Hydrochloride In Dextrose Injection USP | Batch BKBP02601Mfg May 2026 · Exp Apr 2028 | Themis Medicare LtdMaharashtra | The sample does not conform to USP with respect to the test for pH and Bacterial Endotoxin.pH | CDL, KolkataCDSCO lab | Aug 2026 |
| BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION USP (Bupicain- HEAVY) | Batch BKBP O2601Mfg May 2026 · Exp Apr 2028 | Themis Medicare Limited | The sample does not conforms to the USP with respect to Bacterial Endotoxin.Bacterial endotoxins | DTL, JaipurState lab | Aug 2026 |
| Bupivacaine Hydrochloride in Dextrose Injection USP | Batch BD24D2Mfg Dec 2024 · Exp Nov 2026 | Arco Lifesciences (I) Pvt. LtdMaharashtra | The sample does not conform to U.S.P. with respect to test for Visible Particulates In Injection and Description.Description | CDL, KolkataCDSCO lab | Jan 2026 |
| Bupivacaine Injection IP | Batch L2022410BMfg Oct 2024 · Exp Sep 2026 | Protech Telelinks Mouza OgliHimachal Pradesh | The sample does not conform to IP with respect to test for 'Particulate Matter' and is also not of standard quality for the reason stated under "Description".Description | CDL, KolkataCDSCO lab | Nov 2025 |
| Bupivacaine Injection IP | Batch L2022410BMfg Oct 2024 · Exp Sep 2026 | Protech Telelinks Mouza OgliHimachal Pradesh | The sample does not conform to claim as per IP 2022 in respect to the Test of Particulate matter, DescriptionDescription | CDL, KolkataCDSCO lab | Oct 2025 |
| Bupivacaine Hydrochloride in Dextrose Injection USP (Bupivacaine Heavy) | Batch I-1468Mfg May 2024 · Exp Apr 2026 | Jackson Laboratories Pvt.Ltd 22-24Punjab | The sample does not conform to U.S.P. with respect to Assay of Dextrose.Assay | CDL, KolkataCDSCO lab | Oct 2025 |
| Bupivacaine Injection IP | Batch L2022410BMfg Oct 2024 · Exp Sep 2026 | Protech Telelinks Mouza OgliHimachal Pradesh | sample does not conform to IP with respect to test for "Particulate matter" and "Description".Description | CDL, KolkataCDSCO lab | Sep 2025 |
| Bupivacaine Hydrochloride In Dextrose Injection USP 4ml | Batch 17B24002Mfg Mar 2024 · Exp Feb 2026 | Radiant Parenterals Ltd. 242/5 & 6Gujarat | "Determination of volume of Injection in containers".Other | CDL, KolkataCDSCO lab | Jul 2025 |
| Bupivacaine Hydrochloride in Dextrose Injection USP 4 ml | Batch 17B24005Mfg Sep 2024 · Exp Aug 2026 | Radiant Parenterals LtdGujarat | pH, Bacterial Endotoxins Test, Particulate Matter in Injections and DescriptionDescription | CDL, KolkataCDSCO lab | May 2025 |
| Bupivacaine Hydrochloride Injection IP (Bupicain-0.5%) | Batch BPC24007Mfg Dec 2024 · Exp Oct 2026 | Themis Medicare LimitedUttarakhand | Particulate matter and DescriptionDescription | CDL KolkataCDSCO lab | Apr 2025 |
| Bupivacaine Hydrochloride In Dextrose Injection USP | Batch AA4009Mfg Mar 2024 · Exp Feb 2026 | Aishwarya HealthcareSikkim | Particulate matter (visible) and DescriptionDescription | CDL, KolkataCDSCO lab | Mar 2025 |
| Bupivacaine Hydrochloride in Dextrose Injection USP 4 ml | Batch 17B24005Mfg Sep 2024 · Exp Aug 2026 | Radiant Parenterals LtdGujarat | pH and Bacterial EndotoxinspH | CDL KolkataCDSCO lab | Dec 2024 |
Showing 15 of 25 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.