Zydus Recalls BUPROPION Hydrochloride Extended-Release Tablets for Dissolution Failure
Zydus Pharmaceuticals USA Inc. is recalling BUPROPION Hydrochloride Extended-Release Tablets, 300 mg, because the product failed to meet dissolution specifications at an intermediate time point.
What this means for you
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 III, which indicates the product is not likely to cause adverse health consequences. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a direct safety hazard like contamination or mislabeling.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling BUPROPION Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, 500-count bottles. The recall involves 2,472 units of the product, which was distributed nationwide. The specific lot affected is MR3365, with an expiration date of Feb 17.
The recall was initiated because the product did not meet dissolution specifications at an intermediate time point. This means the tablets may not release the medication in the intended manner, potentially affecting the drug's performance.
Consumers and healthcare providers should check their inventory for the specific lot number MR3365 and expiration date Feb 17. If the product matches these details, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- BUPROPION (BUPROPION)
- Brand
- BUPROPION
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 2,472
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 (2)
- Lot #: MR3365
- Exp. Feb 17
Distribution
Distributed nationwide across the United States.
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