Glipizide 2 — Class II drug recall D-1457-2016
Terminated recall by Actavis Inc, reported 2016-08-24, distributed nationwide. Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for th
| Recall number | D-1457-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis Inc, Parsippany, NJ, United States |
| Recall initiated | 2016-06-30 |
| Classified | 2016-08-15 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2017-07-03 |
| Distributed | Nationwide (US) |
| Quantity | 167,152 bottles |
| Reason classes | specification failure |
| NDC | 00591-0900-30 |
| Lot numbers | 02/17, 3132593, 3132594, 3134420, 3134421, 3134422 |
Product
Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30
Reason for recall
Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
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-1457-2016. 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.