Isotretinoin Capsules — Class II drug recall D-0445-2026
Ongoing recall by Teva Pharmaceuticals USA, Inc, reported 2026-04-15, distributed in FL, MS, OH, PR. Superpotent and Subpotent
| Recall number | D-0445-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc, Parsippany, NJ, United States |
| Recall initiated | 2026-01-12 |
| Classified | 2026-04-08 |
| Reported by FDA | 2026-04-15 |
| Distributed | FL, MS, OH, PR |
| Quantity | 21,984 packages |
| Reason classes | potency |
| NDC | 00591-2433, 00591-2433-15, 00591-2433-45, 00591-2434, 00591-2434-15, 00591-2434-45, 00591-2435, 00591-2435-15, 00591-2435-45, 00591-2436, 00591-2436-15, 00591-2436-45, 00591-2451, 00591-2451-15, 00591-2451-45, 00591-2501, 00591-2501-15, 00591-2501-45 |
| Lot numbers | 100055426, 100071518, 100072450 |
| Expiration dates | 2026-02, 2027-04, 2027-07 |
Product
Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack).
Reason for recall
Superpotent and Subpotent
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-0445-2026. 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.