Drugs & medicalClass II

Zydus Pharmaceuticals (USA) Inc recalls Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd.,…

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

Read the official notice →
Date
2025-11-26
Country
United States
Brand
Zydus Pharmaceuticals
Product
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India.…
Classification
Class II
Units
Nationwide in the USA
Category
Drugs & medical
Source
FDA · Drug

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Zydus Pharmaceuticals recalls

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    Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India;…

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  5. 2026-01-07
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  7. 2025-11-12
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    cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

    FDA · DrugZydus Pharmaceuticals (USA) IncNationwide in the USOfficial notice →
  9. 2025-10-08
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    Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India,…

    Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

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  11. 2025-09-24
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All 26 Zydus Pharmaceuticals recalls →

Other drugs & medical recalls in the United States

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    FDA · DrugPark Avenue CompoundingDistributed in MissouriOfficial notice →
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