Bupropion Hydrochloride Extended-Release Tablets Recalled for Failed Dissolution
Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets 200 mg due to failed dissolution specifications. The recall affects 2,016 bottles with lot HAD0630A distributed nationwide.
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: FDA Class III recall with no reported illnesses or injuries. While failed dissolution could affect medication efficacy, the hazard is theoretical rather than documented. Class III recalls without reported adverse events typically score 1-2; Moderate reflects the potential impact on drug delivery.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling Bupropion Hydrochloride Extended-Release Tablets, USP 200 mg due to failed dissolution specifications. The recall affects 2,016 bottles with lot number HAD0630A (expiration date 1/2024) distributed nationwide.
Dissolution specifications are FDA requirements that ensure medications dissolve and are absorbed into the body at the intended rate. When tablets fail to meet these specifications, the drug's delivery to patients may be affected.
Bupropion Hydrochloride is a prescription antidepressant used to treat depression. Patients who have received this product should contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
- Brand
- BUPROPION HYDROCHLORIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Hazard
- Affected units
- 2,016
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 HAD0630A
- exp 1/2024
UPCs (2)
- 0347335738865
- 0347335737868
Distribution
Distributed nationwide across the United States.
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