FDA Drug recall D-1285-2022
Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2…
- FDA Drug
- Class II
- terminated
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class II recall of Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2… by Apotex, citing failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1285-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-07-07 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Apotex |
| Distribution | US |
Product
Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
Reason
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Identifiers
| upc | 360505267682 |
|---|---|
| upc | 360505267637 |
| code_info | Lots: a) TD9591 Exp. 04/2023; b) TD9592 Exp. 04/2023 |
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-1285-2022%22
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