FDA Drug recall D-1341-2020
Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Pa…
- FDA Drug
- Class II
- terminated
- Published 2020-07-01
On 2020-07-01 the FDA classified a Class II recall of Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Pa… by Alembic Pharmaceuticals, citing labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1341-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-10 |
| Published | 2020-07-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Alembic Pharmaceuticals |
| Distribution | US |
Product
Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA, NDC 62332-097-30.
Reason
Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Identifiers
| ndc | 62332-097-30 |
|---|---|
| ndc | 62332-097-71 |
| ndc | 62332-097-91 |
| ndc | 62332-097-31 |
| ndc | 62332-097-10 |
| ndc | 62332-098-30 |
| ndc | 62332-098-31 |
| ndc | 62332-098-91 |
| ndc | 62332-098-10 |
| ndc | 62332-098-71 |
| ndc | 62332-099-30 |
| ndc | 62332-099-31 |
| ndc | 62332-099-71 |
| ndc | 62332-099-91 |
| ndc | 62332-099-10 |
| ndc | 62332-100-30 |
| ndc | 62332-100-31 |
| ndc | 62332-100-71 |
| ndc | 62332-100-91 |
| ndc | 62332-100-10 |
| ndc | 62332-101-30 |
| ndc | 62332-101-31 |
| ndc | 62332-101-71 |
| ndc | 62332-101-91 |
| ndc | 62332-101-10 |
| ndc | 62332-102-30 |
| ndc | 62332-102-31 |
| ndc | 62332-102-71 |
| ndc | 62332-102-91 |
| ndc | 62332-102-10 |
| ndc | 1905003298 |
| code_info | Lot: 1905003298 Exp. 01/31/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1341-2020%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.