FDA Drug recall D-0321-2020
Isotretinoin Capsules, USP 10 mg
- FDA Drug
- Class III
- terminated
- Published 2019-11-20
On 2019-11-20 the FDA classified a Class III recall of Isotretinoin Capsules, USP 10 mg by Amneal Pharmaceuticals, citing failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0321-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-10-16 |
| Published | 2019-11-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amneal Pharmaceuticals |
| Distribution | n/a |
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
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Identifiers
| ndc | 69238-1174-1 |
|---|---|
| ndc | 69238-1174-3 |
| ndc | 69238-1175-1 |
| ndc | 69238-1175-3 |
| ndc | 69238-1017-1 |
| ndc | 69238-1017-3 |
| ndc | 69238-1176-1 |
| ndc | 69238-1176-3 |
| code_info | Batch Numbers: BL10917, BL11017, BL11117, Exp. date 11/2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Amneal Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0321-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.