Zydus Pharmaceuticals USA Inc recalls Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd.,
Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.
Recall notice
Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.
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Source Page by GovInfoNow · govinfonow.com/recall/42771-zydus-pharmaceuticals-usa-inc-recalls-bromocriptine-mesylate-capsules-usp-5 · Recall date May 9, 2016 · FDA enforcement record: FDA #D-1491-2016
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“Zydus Pharmaceuticals USA Inc recalls Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd.,.” GovInfoNow, recall dated May 9, 2016. https://govinfonow.com/recall/42771-zydus-pharmaceuticals-usa-inc-recalls-bromocriptine-mesylate-capsules-usp-5. Based on FDA recall #D-1491-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1491-2016%22&limit=1).
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We’ve drafted a message you can send Zydus Pharmaceuticals (USA) Inc to request your refund or repair — edit it as you like.
Subject: Recall D-1491-2016 — Zydus Pharmaceuticals (USA) Inc Zydus Pharmaceuticals USA Inc recalls Bromocriptine Mesylate Capsul Hello, I own a Zydus Pharmaceuticals USA Inc recalls Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., that is covered by recall D-1491-2016 from Zydus Pharmaceuticals (USA) Inc. 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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Where this comes from
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.
- Official source: FDA Recall #D-1491-2016 (May 9, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1491-2016 to see it in context.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.