Alprazolam Tablets — Class II drug recall D-0013-2018
Terminated recall by The Harvard Drug Group, reported 2017-10-25, distributed nationwide. Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
| Recall number | D-0013-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group, Livonia, MI, United States |
| Recall initiated | 2017-09-26 |
| Classified | 2017-10-19 |
| Reported by FDA | 2017-10-25 |
| Terminated | 2020-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 3,935 cartons |
| Reason classes | specification failure |
| NDC | 00904-5858-61 |
| Lot numbers | 10/17, 1274C151A |
Product
Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-5858-61.
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
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-0013-2018. 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.