Isotretinoin Capsules — Class III drug recall D-0321-2020
Terminated recall by Amneal Pharmaceuticals, Inc., reported 2019-11-20. Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
| Recall number | D-0321-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals, Inc., Brookhaven, NY, United States |
| Recall initiated | 2019-10-16 |
| Classified | 2019-11-13 |
| Reported by FDA | 2019-11-20 |
| Terminated | 2020-11-09 |
| Reason classes | specification failure |
| NDC | 69238-1017, 69238-1017-01, 69238-1017-03, 69238-1174, 69238-1174-01, 69238-1174-03, 69238-1175, 69238-1175-01, 69238-1175-03, 69238-1176, 69238-1176-01, 69238-1176-03 |
| Lot numbers | BL10917, BL11017, BL11117 |
| Expiration dates | 2019-11 |
Product
Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3
Reason for recall
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
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-0321-2020. 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.