CLASS II Drug recall · Reported 14 Sep 2016 · FDA Enforcement Report
Bromocriptine Mesylate Capsules USP, 5 mg recalled
Zydus Pharmaceuticals USA is recalling Bromocriptine Mesylate Capsules USP, 5 mg, distributed nationwide in the US. The recall was initiated on 9 May 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1491-2016
- FDA event ID
- 74233
- Recalling firm
- Zydus Pharmaceuticals USA, Pennington, NJ
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 May 2016
- FDA classified
- 2 Sep 2016
- Reported
- 14 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 9 May 2016 | Recall initiated by company | |
| 2 Sep 2016 | Classified by FDA | +116 days |
| 14 Sep 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot # MP993, Exp10/16; MR2704, Exp 02/17; MR6851, MR8100; Exp 07/17 and MR1210, Exp 12/17
Where was it sold?
US Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zydus Pharmaceuticals USA
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 1 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Tablets, USP 32 mg recalledMethylprednisolone | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.25 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.125 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
Other Bromocriptine recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bromocriptine Mesylate Capsules, USP, 5 mg recalledBromocriptine Mesylate | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Bromocriptine Mesylate, Tablet, 2.5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Bromocriptine Mesylate, Tablet, 2.5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Bromocriptine Mesylate, Tablet, 2.5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |