Bromocriptine Mesylate Capsules recall
FDA recall D-0159-2026 · initiated Oct 23, 2025
Zydus Pharmaceuticals (USA) Inc recalled Bromocriptine Mesylate Capsules in Oct 2025 — an FDA Class II recall (D-0159-2026) because Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 36,624 bottles
Details
- 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
- Recalling company
- Zydus Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Oct 23, 2025
- FDA report date
- Nov 26, 2025
This recall is linked to a product we cover: Bromocriptine Mesylate →
Frequently asked
- Was Bromocriptine Mesylate Capsules recalled?
- Zydus Pharmaceuticals (USA) Inc recalled Bromocriptine Mesylate Capsules in Oct 2025 — an FDA Class II recall (D-0159-2026) because Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Bromocriptine Mesylate Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0159-2026 was: Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
- Is a recalled Bromocriptine Mesylate Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Bromocriptine Mesylate Capsules are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — 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. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0159-2026.