Sun Pharmaceutical Bupropion Extended-Release Tablets Recalled for Failed Dissolution
Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets (150 mg), lot HAD0360A, due to failed dissolution specifications. The 144 bottles were distributed nationwide and may not dissolve at the intended rate.
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: This is an FDA Class III recall with no reported illnesses or adverse reactions. While failed dissolution specifications represent a quality control issue that could affect drug efficacy, the Class III classification and absence of reported harm place this in the Moderate category per the rubric.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, lot HAD0360A, expiring 12/2023. The reason for the recall is failed dissolution specifications. Approximately 144 bottles were distributed nationwide in the United States.
Bupropion is a prescription antidepressant medication. Extended-release formulations are designed to gradually release the medication over time. Failed dissolution specifications mean the tablets may not dissolve at the proper rate, which could affect drug delivery and therapeutic effectiveness.
Patients taking this medication should not discontinue use without consulting their healthcare provider, as stopping antidepressants abruptly can be unsafe. Those who believe they have received the affected product should contact their healthcare provider or pharmacy.
No illnesses or adverse reactions have been reported to the FDA in connection with this recall.
The recalled product
- Product
- BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
- Brand
- BUPROPION HYDROCHLORIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Affected units
- 144
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 #: HAD0360A
- Exp. 12/2023
UPCs (2)
- 0347335738865
- 0347335737868
Distribution
Distributed nationwide across the United States.
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