Isotretinoin Capsules — Class II drug recall D-0439-2024
Ongoing recall by Teva Pharmaceuticals USA, Inc, reported 2024-04-17, distributed nationwide. Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
| Recall number | D-0439-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc, Parsippany, NJ, United States |
| Recall initiated | 2024-03-28 |
| Classified | 2024-04-08 |
| Reported by FDA | 2024-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 5,304 |
| Reason classes | potency, specification failure |
| 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 | 100044259 |
| Expiration dates | 2025-06-30 |
Product
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
Reason for recall
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
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-0439-2024. 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.