Heritage Pharmaceuticals Recalls Gliptizide and Metformin Tablets Due to Impurity
Heritage Pharmaceuticals is recalling specific lots of Gliptizide and Metformin HCL tablets because they failed impurity specifications. The affected bottles were distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses, injuries, or fatalities, and the hazard is a failed impurity specification rather than a known high-risk pathogen or structural defect.
Plain-English summary
Heritage Pharmaceuticals, Inc. is recalling 6,816 bottles of GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles. The recall is due to the product failing impurities/degradation specifications, specifically being out of specification for an unknown impurity.
The affected product is identified by NDC 23155-116-01. The specific lots involved are Lot #18020994 with an expiry date of October 2015, and Lot #18021311 with an expiry date of November 2015. These prescription-only medications were distributed nationwide in the United States, including Puerto Rico.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiry dates. If the product matches the recalled description, it should be discontinued and returned to the pharmacy or supplier for credit. Patients should consult their healthcare provider for alternative treatment options if they have been using the affected medication.
The recalled product
- Product
- GLIPIZIDE AND METFORMIN HCL (GLIPIZIDE AND METFORMIN HCL)
- Brand
- GLIPIZIDE AND METFORMIN HCL
- Manufacturer
- Heritage Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 6,816
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #:18020994
- Expiry: October 2015
- Lot #: 18021311
- Expiry: November 2015.
Distribution
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