Bromocriptine Mesylate Capsules — Class II drug recall D-0159-2026
Ongoing recall by Zydus Pharmaceuticals (USA) Inc, reported 2025-11-26, distributed nationwide. Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine im
| Recall number | D-0159-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2025-10-23 |
| Classified | 2025-11-19 |
| Reported by FDA | 2025-11-26 |
| Distributed | Nationwide (US) |
| Quantity | 36,624 bottles |
| Reason classes | specification failure |
| NDC | 68382-0110, 68382-0110-01, 68382-0110-06 |
| Lot numbers | APR-26, DEC-25, M313934, M313935, M315615, M316809, M405763, M405764, M405765, M414241, M414305, M414307, M414999, OCT-26 |
| Expiration dates | 2025-11-20 |
Product
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06
Reason for recall
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0159-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.