FDA Drug recall D-0159-2026
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only
- FDA Drug
- Class II
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class II recall of Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only by Zydus Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0159-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-23 |
| Published | 2025-11-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Identifiers
| ndc | 68382-110-06 |
|---|---|
| ndc | 68382-110-01 |
| code_info | Lot #: M313934, M313935, M315615, Exp. Date Nov 2025; M316809 , Exp. Date Dec-25; M405765, M405763, M405764, Exp. Date…Lot #: M313934, M313935, M315615, Exp. Date Nov 2025; M316809 , Exp. Date Dec-25; M405765, M405763, M405764, Exp. Date Apr-26; M414999, M414241, M414307, M414305, Exp. Date Oct-26 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0159-2026%22
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