Aripiprazole Tablets — Class II drug recall D-0594-2018
Terminated recall by Hetero Labs, Ltd. - Unit III, reported 2018-02-14, distributed in NJ. CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specificati
| Recall number | D-0594-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hetero Labs, Ltd. - Unit III, Hyderabad, N/A, India |
| Recall initiated | 2018-01-10 |
| Classified | 2018-03-13 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2020-09-21 |
| Distributed | NJ |
| Quantity | 3,000 bottles |
| Reason classes | cgmp |
| NDC | 31722-0819, 31722-0819-01, 31722-0819-05, 31722-0819-30, 31722-0819-31, 31722-0819-32, 31722-0820, 31722-0820-01, 31722-0820-05, 31722-0820-30, 31722-0820-31, 31722-0820-32, 31722-0827, 31722-0827-01, 31722-0827-05, 31722-0827-30, 31722-0827-31, 31722-0827-32, 31722-0828, 31722-0828-01, 31722-0828-05, 31722-0828-30, 31722-0828-31, 31722-0828-32, 31722-0829 and 11 more |
| Lot numbers | ARI17089, ARI17090 |
| Expiration dates | 2019-05 |
Product
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30
Reason for recall
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
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-0594-2018. 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.