Ingredient record · Local anaesthetic injection
Bupivacaine: bans, restrictions and failed batches in India
Last checked 20 September 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Jul 2026
No combination containing Bupivacaine is on India's banned-drugs list. 20 batches of medicines containing Bupivacaine failed a government lab test between June 2021 and January 2026, from 14 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
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 | 11 | 9 | Jan 2026 |
| Bupivacaine | 3 | 1 | Nov 2025 |
| 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 Hydrochloride in Dextrose Injection USP | BD24D2Mfg 2024-12 · Exp 2026-11 | 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 | L2022410BMfg 2024-10 · Exp 2026-09 | 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 | L2022410BMfg 2024-10 · Exp 2026-09 | 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) | I-1468Mfg 2024-05 · Exp 2026-04 | 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 | L2022410BMfg 2024-10 · Exp 2026-09 | 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 | 17B24002Mfg 2024-03 · Exp 2026-02 | 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 | 17B24005Mfg 2024-09 · Exp 2026-08 | 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%) | BPC24007Mfg 2024-12 · Exp 2026-10 | Themis Medicare LimitedUttarakhand | Particulate matter and DescriptionDescription | CDL KolkataCDSCO lab | Apr 2025 |
| Bupivacaine Hydrochloride In Dextrose Injection USP | AA4009Mfg 2024-03 · Exp 2026-02 | Aishwarya HealthcareSikkim | Particulate matter (visible) and DescriptionDescription | CDL, KolkataCDSCO lab | Mar 2025 |
| Bupivacaine Hydrochloride in Dextrose Injection USP 4 ml | 17B24005Mfg 2024-09 · Exp 2026-08 | Radiant Parenterals LtdGujarat | pH and Bacterial EndotoxinspH | CDL KolkataCDSCO lab | Dec 2024 |
| Bupivacaine Hydrochloride in Dextrose Injection USP 4 ml | 17B24004Mfg 2024-06 · Exp 2026-05 | Radiant Parenterals LtdGujarat | pH, Bacterial Endotoxins and SterilitySterility | CDL KolkataCDSCO lab | Dec 2024 |
| BUPIVACAINE HYDROCHLORI DE INJECTION IP 0.5% | BCV22315Mfg 2023-12 · Exp 2025-11 | Nandani Medical Laboratories Pvt. LtdMadhya Pradesh | Particulate mattter and DescriptionDescription | CDL KolkataCDSCO lab | Dec 2024 |
| Bupivacaine Hydrochloride in Dextrose Inj. USP 0.50% 4 ml Amp | D2258/23- 24Mfg 2023-09 · Exp 2025-08 | Supplied by M/s. Kerala Medical services Corporation LimitedKerala | It fails the test Sterility as per USPSterility | SDTL ThiruvananthapuramState lab | Apr 2024 |
| Bupivacaine HCl in Dextrose Injection USP (5 mg+80 mg/ml) | V23146Mfg 2023-06 · Exp 2025-05 | Vital Healthcare Pvt. Ltd | Description & Particulate MatterDescription | CDL KolkataCDSCO lab | Mar 2024 |
| Bupivacaine Heavy (Bupivacaine Hydrochloride in Dextrose Injection USP 4 ml), | I?5319Mfg 2022-10 · Exp 2024-09 | Jackson Laboratories Pvt. LtdPunjab | Description Foreign and Particulate matterDescription | CDL KolkataCDSCO lab | May 2023 |
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.