Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0149-2017·Announced 2016-11-30

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.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 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: dissolution-failure
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.

Same brand · BUPROPION

Low
Zydus Recalls Bupropion Hydrochloride Extended-Release Tablets for Dissolution Failures
FDA (Drugs) · 2016-12-28

Same manufacturer · Zydus Pharmaceuticals USA Inc

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