Use caution Drug recall · FDA · Published October 23, 2025

Zydus Recalls Bromocriptine Mesylate Capsules Due to Impurity Issues

Zydus Pharmaceuticals recalls specific lots of Bromocriptine Mesylate Capsules, USP, 5 mg due to failed impurity specifications. Check your bottle's lot number.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0159-2026Drug Zydus ›

Use caution until it’s fixed

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.

Take action

Contact the company

Recalling firmZydus Pharmaceuticals (USA) Inc73 Route 31 N · Pennington, NJ 08534-3601

✎ GovInfoNow plain-language explainer

Zydus Pharmaceuticals (USA) Inc is recalling Bromocriptine Mesylate Capsules, USP, 5 mg because they contain out-of-specification levels of a specific impurity called 2-Bromoergine. The recall covers approximately 36,624 bottles distributed nationwide in the USA. No remedy or return instructions are currently listed in the record. Read more at govinfonow.com/recall/31680-zydus-recalls-bromocriptine-mesylate-capsules-due-to-impurity-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/31680-zydus-recalls-bromocriptine-mesylate-capsules-due-to-impurity-issues · Updated October 9, 2026 · FDA enforcement record: FDA #D-0159-2026

Cite this page

“Zydus Recalls Bromocriptine Mesylate Capsules Due to Impurity Issues.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/31680-zydus-recalls-bromocriptine-mesylate-capsules-due-to-impurity-issues. Based on FDA recall #D-0159-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0159-2026%22&limit=1).

The FDA announced on Oct. 23, 2025, that Zydus Pharmaceuticals is recalling Bromocriptine Mesylate Capsules, USP, 5 mg due to failed impurity specifications. The agency said the recall addresses out-of-specification results for the 2-Bromoergine impurity.

How to tell if you have it

Brand: Zydus
Product: Bromocriptine Mesylate Capsules 5 mg, 30 Capsules per bottle
NDC: 68382-110-06
Lot codes: M313934, M313935, M315615 (Exp. Nov 2025); M316809 (Exp. Dec-25); M405765, M405763, M405764 (Exp. Apr-26); M414999, M414241, M414307, M414305 (Exp. Oct-26)
Units affected: 36,624 bottles

The hazard

The recall is due to out-of-specification results for the 2-Bromoergine impurity in Bromocriptine Mesylate Capsules. The FDA's FAERS database contains 522 adverse-event reports naming this product, including 444 marked as serious and 28 listing a death.

Context

GovInfoNow's records show Zydus Pharmaceuticals has 53 other recalls on record since March 14, 2012. Recent Zydus recalls include Mirabegron tablets in August 2026 and Erythromycin tablets in April 2026, both involving N-Nitroso impurity risks. Other recent recalls of similar products include Rising Pharma's Temozolomide capsules (March 3, 2026), Unichem's Bisoprolol/Hydrochlorothiazide tablets (Jan. 21, 2026), and Hikma's Ramipril capsules (Aug. 24, 2026).

How to tell if you have this one

Check your bottle for NDC 68382-110-06 and look for one of these lot numbers: M313934, M313935, M315615, M316809, M405765, M405763, M405764, M414999, M414241, M414307, or M414305. Verify the expiration dates match: Nov 2025 for lots M313934, M313935, and M315615; Dec-25 for lot M316809; Apr-26 for lots M405765, M405763, and M405764; and Oct-26 for lots M414999, M414241, M414307, and M414305.

Brand
Zydus
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check your lot number
Compare the lot number on your Bromocriptine Mesylate Capsules bottle against the list of recalled lots provided in the record.
Contact your pharmacist or doctor
If you have a recalled lot, speak with your healthcare provider or pharmacist for guidance on what to do next, as no specific remedy is listed in the recall record.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 34 days after the firm started it.

Oct 23, 2025Firm started the recall
Nov 19, 2025FDA classified it Class II
Nov 26, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/31680-zydus-recalls-bromocriptine-mesylate-capsules-due-to-impurity-issues">Zydus Recalls Bromocriptine Mesylate Capsules Due to Impurity Issues (GovInfoNow)</a>

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-0159-2026 (October 23, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0159-2026 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.