GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets — Class II drug recall D-0436-2015
Terminated recall by Heritage Pharmaceuticals, Inc., reported 2015-04-15, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
| Recall number | D-0436-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heritage Pharmaceuticals, Inc., Eatontown, NJ, United States |
| Recall initiated | 2015-03-25 |
| Classified | 2015-04-07 |
| Reported by FDA | 2015-04-15 |
| Terminated | 2017-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 6,816 bottles |
| Reason classes | specification failure |
| NDC | 23155-0115, 23155-0115-01, 23155-0115-10, 23155-0116, 23155-0116-01, 23155-0116-10, 23155-0117, 23155-0117-01, 23155-0117-10 |
| Lot numbers | 18020994, 18021311 |
| Expiration dates | 2015-10-20, 2015-11-20 |
Product
GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724, NDC: 23155-116-01.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for 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-0436-2015. 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.