Zydus Pharmaceuticals recalls 5mg Bromocriptine Mesylate capsules due to detected impurities. Rx-only medication with specific lot numbers and expiration dates. Consumers should contact pharmacy for guidance.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Zydus Pharmaceuticals is recalling 5mg Bromocriptine Mesylate capsules because they contain an impurity that failed quality tests. This could pose a health risk if taken as prescribed, but the recall does not specify immediate danger to users.
The capsules contain an impurity called 2-Bromoergine that failed quality tests. This impurity could potentially cause health issues if the medication is taken as directed, though the exact risk level is not specified in the recall.
Prescription medication users who have the specific lot numbers listed in the recall. Patients taking Bromocriptine for conditions like Parkinson's disease or prolactin disorders are most at risk.
Check the product label for the NDC code 68382-110-06 and lot numbers M313934, M313935, M315615, M316809, M405763, M405764, M405765, M414241, M414305, M414307, M414999. The capsules expire by November 2025, December 2025, or April 2026.
Look for the NDC code 68382-110-06 and lot numbers listed in the recall.
Ask your pharmacy if you have the recalled capsules and get guidance on next steps.
The recall states the capsules contain an impurity that failed quality tests, but the exact health risk is not specified. Consult your doctor or pharmacist for advice.
The affected lot numbers are M313934, M313935, M315615, M316809, M405763, M405764, M405765, M414241, M414305, M414307, M414999.
Check the product label for the NDC code 68382-110-06 and the specific lot numbers listed in the recall.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0159-2026 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0159-2026 from Zydus Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
