CLASS II ONGOING Drug recall · Reported 26 Nov 2025 · FDA Enforcement Report
Bromocriptine Mesylate Capsules, USP, 5 mg recalled
Zydus Pharmaceuticals (USA) is recalling Bromocriptine Mesylate Capsules, USP, 5 mg per, distributed nationwide in the US. The recall was initiated on 23 Oct 2025 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-0159-2026
- FDA event ID
- 97847
- Recalling firm
- Zydus Pharmaceuticals (USA), Pennington, NJ
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Oct 2025
- FDA classified
- 19 Nov 2025
- Reported
- 26 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 23 Oct 2025 | Recall initiated by company | |
| 19 Nov 2025 | Classified by FDA | +27 days |
| 26 Nov 2025 | Published in enforcement report | +7 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 (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
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 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Bromocriptine Mesylate Capsules, USP, 5 mg per recalled?
Yes. Zydus Pharmaceuticals (USA) recalled Bromocriptine Mesylate Capsules, USP, 5 mg per on 23 Oct 2025. The recall is Class II and its status is Ongoing. Recall number D-0159-2026.
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Which lots are affected?
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
Where was it sold?
Nationwide in the USA
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
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| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals (USA) | Other | Nationwide |
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Other Bromocriptine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bromocriptine Mesylate Capsules USP, 5 mg recalledBromocriptine Mesylate | Zydus Pharmaceuticals USA | Potency & Assay | Nationwide |