Sun Pharmaceutical Recalls Vecuronium Bromide Due to Glass Particulates
Sun Pharmaceutical Industries is recalling Vecuronium Bromide for Injection because glass particles were detected in the product.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this as a Class I recall, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling Vecuronium Bromide for Injection, 10 mg vials, due to the presence of particulate matter. The foreign matter identified in the product is glass.
The recall affects 12,534 cartons and 125,340 vials of the medication. The specific lots involved are JKS0443A, JKS0444A, and JKS0477A, all with an expiration date of 03/2019. The product was distributed nationwide in the United States.
Healthcare providers and patients should stop using the affected lots of Vecuronium Bromide for Injection. The FDA has classified this as a Class I recall, which is the most serious type of recall.
The recalled product
- Product
- VECURONIUM BROMIDE (VECURONIUM BROMIDE)
- Brand
- VECURONIUM BROMIDE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Injection
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: JKS0443A
- JKS0444A
- JKS0477A
- EXP 03/2019
UPCs (1)
- 0347335932447
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Sun Pharmaceutical Industries, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · VECURONIUM BROMIDE
- SevereSun Pharmaceutical Recalls Vecuronium Bromide Injection Due to Glass Particles
FDA (Drugs) · 2019-01-16
Same manufacturer · Sun Pharmaceutical Industries, Inc.
See all →- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08
Same hazard · glass particulate
See all →- SevereTestosterone Pellet 200 mg Recalled for Glass Particulate Matter
FDA (Drugs) · 2025-05-14
- HighTestosterone Pellet 200 mg Recalled for Glass Particulate Matter
FDA (Drugs) · 2025-05-14
- HighProgesterone Injection Recalled for Glass Particulate Matter in Vials
FDA (Drugs) · 2024-08-07
- HighCyanocobalamin Injection Vials Recalled for Glass Particulate Contamination
FDA (Drugs) · 2024-07-24
- HighEye and Ear Dropper Recalled for Potential Glass Particulate Contamination
FDA (Devices) · 2023-06-21
Similar recalls
- SevereBen Venue Recalls Vecuronium Bromide Injection Due to Particulate Matter
FDA (Drugs) · 2012-10-03
- SevereSagent Recalls Vecuronium Bromide Injection Due to Manufacturing Deviations
FDA (Drugs) · 2013-06-26
- SevereTeva Recalls Vecuronium Bromide Injection Due to Sterility Concerns
FDA (Drugs) · 2021-03-03
- CriticalPfizer Recalls Vancomycin Hydrochloride Vials Due to Glass Particulate Matter
FDA (Drugs) · 2017-12-27
- SeverePharmedium Recalls Vecuronium Bromide Injection Due to Sterility Concerns
FDA (Drugs) · 2018-02-28
- SevereTeva Vecuronium Bromide Injection Recalled for Sterility Assurance
FDA (Drugs) · 2021-08-25