Tretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications
Teva Pharmaceuticals USA is recalling Tretinoin Capsules 10 mg due to failed dissolution specifications and out-of-specification test results. Approximately 1,175 bottles distributed nationwide may not dissolve properly.
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 II recall involving a pharmaceutical formulation defect. No illnesses, injuries, or deaths are reported in the source text. The hazard is a failure to meet dissolution specifications, which is a manufacturing/quality control issue rather than a direct safety threat with confirmed harm.
Plain-English summary
Teva Pharmaceuticals USA is recalling Tretinoin Capsules, 10 mg, 100 count bottles (NDC 0555-0808-02, Lot #100022970, expiration 08/2022) due to failed dissolution specifications. Testing revealed low and out-of-specification results for dissolution, which means the capsules may not dissolve as intended in the body.
Approximately 1,175 bottles were distributed nationwide in the United States. Tretinoin is a prescription medication used for various dermatological conditions. If the medication does not dissolve properly, patients may not receive the intended therapeutic benefit.
Consumers who have this product should contact their pharmacist or healthcare provider. Do not stop taking the medication without consulting a healthcare professional, as this could affect treatment. Return the medication to the pharmacy where it was obtained.
The recalled product
- Product
- Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Capsule
- Hazard
- failed-dissolution
- out-of-specification
- reduced-bioavailability
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 #: 100022970
- Exp. 08/2022
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27