Glipizide extended-release tablets — Class II drug recall D-0476-2017
Terminated recall by Actavis Inc, reported 2017-02-22, distributed nationwide. Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour tes
| Recall number | D-0476-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis Inc, Parsippany, NJ, United States |
| Recall initiated | 2017-01-30 |
| Classified | 2017-02-15 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2018-03-13 |
| Distributed | Nationwide (US) |
| Quantity | 499,320 units |
| Reason classes | specification failure |
| NDC | 00591-0900-30 |
| Lot numbers | 3134201, 3134202, 3134319, 3135246, 3135247, 3136781, 3136782, 3136903, 3136904, 3138250, 3138968, 3140000 |
| Expiration dates | 2017-05-31, 2017-06-30, 2017-07-31, 2017-08-31, 2017-09-30, 2017-10-31 |
Product
Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4
Reason for recall
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at 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-0476-2017. 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.