Class II · ModerateActive recall
Bromocriptine Mesylate
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: 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
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byZydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534 foreign manufacturer
| Brand name | BROMOCRIPTINE MESYLATE |
| Generic name | BROMOCRIPTINE MESYLATE |
| Active ingredient(s) | BROMOCRIPTINE MESYLATE |
| Distributed by / for | Zydus Pharmaceuticals, Pennington, NJ 08534 |
| NDC | 68382-110-06 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc |
| Distribution | Nationwide in the USA |
| Quantity | 36,624 bottles |
| Recall initiated | 2025-10-23 |
| Report date | 2025-11-26 |
| Recall completed | — |
| Recall number | D-0159-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Pennington NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.