FDA Drug recall D-0471-2017
Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9
- FDA Drug
- Class III
- terminated
- Published 2017-02-15
On 2017-02-15 the FDA classified a Class III recall of Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9 by Apotex, citing superpotent Drug: Product may not meet specifications throughout shelf life.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0471-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-12-19 |
| Published | 2017-02-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Apotex |
| Distribution | US |
Product
Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3.
Reason
Superpotent Drug: Product may not meet specifications throughout shelf life.
Identifiers
| code_info | Lot #: MJ7746, Exp 04/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Apotex
- Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manu…
FDA Drug · Class II · 2026-10-07 · Apotex - Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9…
FDA Drug · Class II · 2026-09-02 · Apotex - Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg…
FDA Drug · Class II · 2026-04-22 · Apotex - Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp
FDA Drug · Class II · 2026-03-25 · Apotex - Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C…
FDA Drug · Class II · 2025-10-08 · Apotex
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0471-2017%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.