Class II · ModerateRecall completed
Tretinoin Capsules
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #s: 100022971, Exp. 08/2022; 100022972, Exp. 05/2023; 100028920, Exp. 09/2023
Where it was soldNationwide in the U.S.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | Teva Pharmaceuticals USA Inc |
| NDC | 0555-0808-02 |
Show the full FDA record
| Full product label | Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02. |
| Recalling firm | Teva Pharmaceuticals USA Inc |
| Distribution | Nationwide in the U.S. |
| Quantity | 4941 bottles |
| Recall initiated | 2022-06-14 |
| Report date | 2022-06-29 |
| Recall completed | 2023-04-27 |
| Recall number | D-1156-2022 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Parsippany NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.