Upsher-Smith Recalls Bexarotene Capsules Due to Dissolution Failures
Upsher-Smith Laboratories is recalling 166 bottles of Bexarotene 75 mg capsules because they failed to meet dissolution specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a direct contamination or acute injury risk.
Plain-English summary
Upsher-Smith Laboratories, Inc. is recalling 166 bottles of Bexarotene Capsules, 75 mg, 100 capsules per bottle. The product is identified by NDC 0832-0285-00, Lot A2610, and an expiration date of 3/2020.
The recall was initiated because the product failed to meet dissolution specifications. This means the capsules may not release the medication in the body as intended, potentially affecting the drug's effectiveness.
The affected product was distributed in Kentucky, Ohio, New Jersey, and Louisiana. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.
The recalled product
- Product
- BEXAROTENE (BEXAROTENE)
- Brand
- BEXAROTENE
- Manufacturer
- Upsher Smith Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 166
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 (1)
- Lot: A2610. exp 3/2020
UPCs (1)
- 0308320285009
Distribution
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