FDA Drug recall D-0436-2015
GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only
- FDA Drug
- Class II
- terminated
- Published 2015-04-15
On 2015-04-15 the FDA classified a Class II recall of GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only by Heritage Pharmaceuticals, citing failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0436-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-25 |
| Published | 2015-04-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Heritage Pharmaceuticals |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Identifiers
| ndc | 23155-115-01 |
|---|---|
| ndc | 23155-115-10 |
| ndc | 23155-116-01 |
| ndc | 23155-116-10 |
| ndc | 23155-117-01 |
| ndc | 23155-117-10 |
| code_info | Lot #:18020994, Expiry: October 2015; Lot #: 18021311, Expiry: November 2015. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Heritage Pharmaceuticals
- CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Br…
FDA Drug · Class II · 2026-08-19 · Heritage Pharmaceuticals - Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, I…
FDA Drug · Class II · 2025-11-05 · Heritage Pharmaceuticals - Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, I…
FDA Drug · Class II · 2025-11-05 · Heritage Pharmaceuticals - Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, I…
FDA Drug · Class II · 2025-11-05 · Heritage Pharmaceuticals - Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman,…
FDA Drug · Class II · 2025-11-05 · Heritage Pharmaceuticals
All Heritage Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0436-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.