Claravis isotretinoin 10 mg capsules recalled for out-of-specification impurity
Teva Pharmaceuticals is recalling Claravis (isotretinoin) 10 mg capsules due to failure to meet impurity specifications. The affected lots were distributed nationwide in the USA, Puerto Rico, and the Virgin Islands.
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: This is an FDA Class II recall. The source text indicates a failed impurities/degradation specification with no reported illnesses or injuries. The hazard is a quality/manufacturing defect rather than a confirmed contamination event, placing it in the Moderate category.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling Claravis (isotretinoin) 10 mg capsules. The recall involves 5,101 cartons distributed nationwide in the USA, Puerto Rico, and the Virgin Islands. The capsules are available in 100-count and 30-count cartons.
The recall was initiated because the drug failed to meet specifications for a specific impurity called Tretinoin. Isotretinoin is an oral prescription medication used to treat severe acne. The presence of out-of-specification impurities raises concerns about drug quality and safety.
The affected lots are #100067507 and #100067508, with an expiration date of July 31, 2026. Patients currently taking this medication should contact their healthcare provider or pharmacy immediately to discuss their options, which may include discontinuing use or switching to an alternative supply.
Healthcare providers and patients with stock of the affected lots should stop distribution and use of the product and return or dispose of it according to pharmacy protocol.
The recalled product
- Product
- CLARAVIS (ISOTRETINOIN)
- Brand
- CLARAVIS
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug — Prescription / Retinoid
- Affected units
- 5,101
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 (3)
- Lots#: 100067507
- 100067508
- Exp 07/31/2026
Distribution
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