Tretinoin Capsules — Class II drug recall D-1156-2022
Terminated recall by Teva Pharmaceuticals USA Inc, reported 2022-06-29, distributed nationwide. Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
| Recall number | D-1156-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA Inc, Parsippany, NJ, United States |
| Recall initiated | 2022-06-14 |
| Classified | 2022-06-23 |
| Reported by FDA | 2022-06-29 |
| Terminated | 2023-04-27 |
| Distributed | Nationwide (US) |
| Quantity | 4,941 bottles |
| Reason classes | specification failure |
| NDC | 00555-0808-02 |
| Lot numbers | 100022971, 100022972, 100028920 |
| Expiration dates | 2022-08, 2023-05, 2023-09 |
Product
Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
Reason for recall
Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1156-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.