Zydus Issues Class II Recall of Bromocriptine Mesylate Capsules Over Impurity Concerns
Key Clinical Summary
- Product recall: Zydus Pharmaceuticals has voluntarily recalled Bromocriptine Mesylate Capsules, USP, 5 mg (30-count bottles) following US Food and Drug Administration (FDA) classification as a Class II drug recall.
- Reason for recall: Multiple lots showed out-of-specification results for the 2-Bromoergine impurity, indicating failed impurities/degradation testing.
- Scope: Recall affects 36 624 bottles across numerous lots distributed nationwide in the US; notification to consignees began October 23, 2025.
Zydus Pharmaceuticals (USA) Inc has initiated a voluntary Class II recall of Bromocriptine Mesylate Capsules, USP, 5 mg (30-count bottles; NDC 68382-110-06). The affected product was manufactured by Zydus Lifesciences Ltd in Ahmedabad, India, and distributed nationwide in the US. In total, 36 624 bottles are included in the recall, covering multiple lots with expiration dates ranging from November 2025 to October 2026. No press release has been issued, and the FDA lists the recall status as ongoing.
According to the FDA Enforcement Report, the recall was initiated after the product failed impurities and degradation specifications, specifically due to an out-of-specification result for the 2-Bromoergine impurity, a degradation product associated with bromocriptine. While a Class II classification indicates that exposure to the violative product may cause temporary or medically reversible adverse health consequences, the probability of serious harm is considered remote. Consignees were notified by letter beginning on October 23, 2025, and the FDA assigned its classification on November 19, 2025.
Bromocriptine mesylate is a dopamine agonist used in the management of several conditions, including Parkinson disease, hyperprolactinemia, pituitary adenomas, and type 2 diabetes (as a quick-release formulation). Pharmacists are encouraged to review inventory for the specified lots and follow standard return and reporting procedures for recalled prescription products.
