Bupropion Hydrochloride 150 mg Extended-Release Tablets Recalled for Activated Carbon Contamination
Sun Pharmaceutical is recalling Bupropion Hydrochloride 150 mg extended-release tablets distributed nationwide due to activated carbon particles from desiccant canisters found in bottles. No illnesses have been reported.
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: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is a manufacturing defect—activated carbon particles from desiccant material—rather than a safety-critical contamination. Per the rubric, Class III recalls are typically scored 1 or 2; the presence of foreign substance justifies a score of 2 (Moderate) rather than 1 (Low).
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling Bupropion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg due to the presence of activated carbon particles that escaped from desiccant canisters inside bottles. Approximately 9,804 bottles were affected and distributed nationwide.
Affected lot numbers are JKX5126A, JKX5127A, JKX5128A, JKX5126B, JKX5128B, JKX5126C, JKX5127C, and JKX5128C, all with expiration date 10/2022. The medication was distributed in 60-count, 100-count, and 500-count bottles. No illnesses or injuries related to this contamination have been reported. Patients who believe they have an affected bottle should contact their pharmacy or physician.
The recalled product
- Product
- BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
- Brand
- BUPROPION HYDROCHLORIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug
- Hazard
- foreign-substance
- contamination
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 (9)
- Lot #: a) JKX5126A
- JKX5127A
- JKX5128A
- Exp 10/2022
- b) JKX5126B
- JKX5128B
- c)JKX5126C
- JKX5127C
- JKX5128C
UPCs (2)
- 0347335738865
- 0347335737868
Distribution
Distributed nationwide across the United States.
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