Aripiprazole Tablets — Class II drug recall D-0539-2023
Ongoing recall by Ascend Laboratories, LLC, reported 2023-04-26, distributed nationwide. Out of specification (OOS) for Spectroscopic Identification test by IR.
| Recall number | D-0539-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories, LLC, Parsippany, NJ, United States |
| Recall initiated | 2023-03-17 |
| Classified | 2023-04-19 |
| Reported by FDA | 2023-04-26 |
| Distributed | Nationwide (US) |
| Quantity | 135 bottles |
| Reason classes | specification failure |
| NDC | 67877-0430, 67877-0430-01, 67877-0430-03, 67877-0430-05, 67877-0430-32, 67877-0430-33, 67877-0430-38, 67877-0431, 67877-0431-01, 67877-0431-03, 67877-0431-05, 67877-0431-32, 67877-0431-33, 67877-0431-38, 67877-0432, 67877-0432-01, 67877-0432-03, 67877-0432-05, 67877-0432-32, 67877-0432-33, 67877-0432-38, 67877-0433, 67877-0433-01, 67877-0433-03, 67877-0433-05 and 15 more |
| Lot numbers | 22143120 |
| Expiration dates | 2024-06-20 |
Product
Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05
Reason for recall
Out of specification (OOS) for Spectroscopic Identification test by IR.
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-0539-2023. 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.