Zydus Recalls Bromocriptine Mesylate Capsules Due to Stability Test Failures
Zydus Pharmaceuticals is recalling 14,808 bottles of Bromocriptine Mesylate 5 mg capsules because stability samples failed impurity tests.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text describes a failure in stability testing (impurities) without reporting specific injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling 14,808 bottles of Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles. The product is distributed nationwide in the United States. The recall involves specific lots: MP993 (Exp 10/16), MR2704 (Exp 02/17), MR6851 (Exp 07/17), MR8100 (Exp 07/17), and MR1210 (Exp 12/17).
The recall was initiated because out-of-specification results were observed in related substance tests during the analysis of 24-month long-term stability samples for two batches. The stability samples were stored at 25 degrees Celsius and 65% relative humidity. This indicates that the product may not meet established impurity or degradation specifications.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or Zydus Pharmaceuticals for further instructions. The product is a prescription-only medication manufactured by Cadila Healthcare Ltd. and distributed by Zydus Pharmaceuticals USA Inc.
The recalled product
- Product
- BROMOCRIPTINE MESYLATE (BROMOCRIPTINE MESYLATE)
- Brand
- BROMOCRIPTINE MESYLATE
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 14,808
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot # MP993
- Exp10/16
- MR2704
- Exp 02/17
- MR6851
- MR8100
- Exp 07/17 and MR1210
- Exp 12/17
UPCs (1)
- 0368382110015
Distribution
Distributed nationwide across the United States.
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