Zydus Recalls Bromocriptine Capsules Due to Impurity Issues
Zydus Pharmaceuticals recalls specific lots of 5 mg Bromocriptine Mesylate capsules due to failed impurity specifications. Check your lot numbers.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Zydus Pharmaceuticals USA Inc is recalling specific lots of Bromocriptine Mesylate Capsules USP, 5 mg, in 30-count bottles. The recall was initiated because stability testing revealed that the products contained out-of-specification related substances (impurities or degradation). This issue was identified during analysis of long-term stability samples stored at 25 degrees Celsius and 65% relative humidity. Read more at govinfonow.com/recall/42771-zydus-recalls-bromocriptine-capsules-due-to-impurity-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/42771-zydus-recalls-bromocriptine-capsules-due-to-impurity-issues · Updated October 9, 2026 · FDA enforcement record: FDA #D-1491-2016
Cite this page
“Zydus Recalls Bromocriptine Capsules Due to Impurity Issues.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42771-zydus-recalls-bromocriptine-capsules-due-to-impurity-issues. Based on FDA recall #D-1491-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1491-2016%22&limit=1).
Why it’s dangerous
The recalled capsules failed impurity and degradation specifications during stability testing. This means the chemical composition of the drug may have changed over time, potentially affecting its safety or efficacy, although specific health outcomes are not detailed in this record.
Who’s affected
Patients in the United States who have been prescribed Bromocriptine Mesylate Capsules USP, 5 mg, distributed by Zydus Pharmaceuticals USA Inc. are affected. The risk is primarily related to taking medication that may not meet purity specifications.
How to tell if you have this one
Check your medication bottle for the following details: Brand is Zydus Pharmaceuticals (distributed by Cadila Healthcare ltd.). Product is Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles. Look for NDC 68382-110-06 and one of these lot numbers with expiration dates: Lot MP993 (Exp 10/16), Lot MR2704 (Exp 02/17), Lots MR6851 or MR8100 (Exp 07/17), or Lot MR1210 (Exp 12/17).
- Brand
Zydus Pharmaceuticals- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Bromocriptine Mesylate Capsules match the recalled lot numbers and expiration dates listed in the record.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to determine the appropriate next steps for your specific prescription.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
How many bottles are being recalled?
A total of 14,808 bottles are included in this recall.
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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.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- 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.