Bromocriptine Mesylate Capsules USP — Class II drug recall D-1491-2016
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2016-09-14, distributed nationwide. Failed impurities/degradation specifications: Out of specification results noticed in related substance test d
| Recall number | D-1491-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States |
| Recall initiated | 2016-05-09 |
| Classified | 2016-09-02 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2018-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 14,808 bottles |
| Reason classes | specification failure |
| NDC | 68382-0110, 68382-0110-01, 68382-0110-06 |
| Lot numbers | 02/17, 07/17, 10/16, 12/17, MP993, MR1210, MR2704, MR6851, MR8100 |
Product
Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06
Reason for recall
Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.
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-1491-2016. 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.