FDA Drug recall D-0539-2023
Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Asc…
- FDA Drug
- Class II
- ongoing
- Published 2023-04-26
On 2023-04-26 the FDA classified a Class II recall of Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Asc… by Ascend Laboratories, citing out of specification (OOS) for Spectroscopic Identification test by IR.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0539-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-17 |
| Published | 2023-04-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascend Laboratories |
| Distribution | US |
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
Out of specification (OOS) for Spectroscopic Identification test by IR.
Identifiers
| ndc | 67877-431-03 |
|---|---|
| ndc | 67877-431-01 |
| ndc | 67877-431-05 |
| ndc | 67877-431-33 |
| ndc | 67877-431-38 |
| ndc | 67877-431-32 |
| ndc | 67877-432-03 |
| ndc | 67877-432-01 |
| ndc | 67877-432-05 |
| ndc | 67877-432-33 |
| ndc | 67877-432-38 |
| ndc | 67877-432-32 |
| ndc | 67877-433-03 |
| ndc | 67877-433-01 |
| ndc | 67877-433-05 |
| ndc | 67877-433-33 |
| ndc | 67877-433-38 |
| ndc | 67877-433-32 |
| ndc | 67877-434-03 |
| ndc | 67877-434-01 |
| ndc | 67877-434-05 |
| ndc | 67877-434-33 |
| ndc | 67877-434-38 |
| ndc | 67877-435-03 |
| ndc | 67877-435-01 |
| ndc | 67877-435-05 |
| ndc | 67877-435-33 |
| ndc | 67877-435-38 |
| ndc | 67877-430-03 |
| ndc | 67877-430-01 |
| ndc | 67877-430-05 |
| ndc | 67877-430-33 |
| ndc | 67877-430-38 |
| ndc | 67877-430-32 |
| code_info | Lot #22143120, Exp. Date: June 2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Ascend Laboratories
- Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laborator…
FDA Drug · Class III · 2026-08-05 · Ascend Laboratories - Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratorie…
FDA Drug · Class III · 2026-08-05 · Ascend Laboratories - Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratori…
FDA Drug · Class III · 2026-08-05 · Ascend Laboratories - Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA
FDA Drug · Class II · 2026-07-29 · Ascend Laboratories - Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by:…
FDA Drug · Class III · 2026-07-29 · Ascend Laboratories
All Ascend Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0539-2023%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.