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
Reported: November 26, 2025 Initiated: October 23, 2025 #D-0159-2026
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Details
- Recalling Firm
- Zydus Pharmaceuticals (USA) Inc
- Units Affected
- 36,624 bottles
- Distribution
- Nationwide in the USA
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Zydus Pharmaceuticals (USA) Inc. Units affected: 36,624 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 26, 2025. Severity: Moderate. Recall number: D-0159-2026.
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