# FDA recall D-0436-2015

> **Heritage Pharmaceuticals, Inc.** · Class II · drug recall initiated 2015-03-25.

## 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.

## Distribution

U.S. Nationwide including Puerto Rico.

## Key facts

- **Recall number:** D-0436-2015
- **Recalling firm:** Heritage Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-03-25
- **Report date:** 2015-04-15
- **Termination date:** 2017-05-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Eatontown, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0436-2015

## Citation

> AI Analytics. FDA recall D-0436-2015. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0436-2015. Source: US FDA. Licensed CC0.

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