Use cautionDrug recall · FDA · Published March 25, 2015
Heritage Pharma Recalls Glipizide/Metformin Tablets Due to Impurities
Heritage Pharmaceuticals recalls specific lots of Glipizide and Metformin Hydrochloride tablets due to failed impurity specifications. Check your bottle's lot number.
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Take action
Contact the company
📍Recalling firmHeritage Pharmaceuticals, Inc.12 Christopher Way Ste 300 · Eatontown, NJ 07724-3331
✎ GovInfoNow plain-language explainer
Heritage Pharmaceuticals is recalling 6,816 bottles of Glipizide and Metformin Hydrochloride Tablets (2.5 mg/500 mg) because they contain unknown impurities that exceed specification limits. The affected products were distributed nationwide in the U.S., including Puerto Rico. The record does not specify any reported injuries or a specific remedy for consumers. Read more at govinfonow.com/recall/44821-heritage-pharmaceuticals-inc-recalls-glipizide-and-metformin-hydrochloride-tablets-usp.
“Heritage Pharma Recalls Glipizide/Metformin Tablets Due to Impurities.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44821-heritage-pharmaceuticals-inc-recalls-glipizide-and-metformin-hydrochloride-tablets-usp. Based on FDA recall #D-0436-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0436-2015%22&limit=1).
The FDA announced on March 25, 2015, that Heritage Pharmaceuticals Inc. voluntarily recalled Glipizide and Metformin Hydrochloride Tablets due to failed impurity specifications. The agency classified the recall as Class II.
How to tell if you have it
Brand: Heritage Pharmaceuticals
Product: GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only
NDC: 23155-116-01
Lot #:18020994, Expiry: October 2015
Lot #: 18021311, Expiry: November 2015
Quantity: 6,816 Bottles
The hazard
According to the FDA, the recalled tablets are out of specification for an unknown impurity. The agency classified the recall as Class II.
Context
GovInfoNow's records show Heritage Pharmaceuticals Inc has had 11 other recalls since February 25, 2015. Recent brand recalls include a July 30, 2026 recall of Clindamycin Oral Solution due to foreign particles and an October 6, 2025 recall of Desipramine Tablets for N-Nitroso impurity risk. Other recent recalls of similar products include Rising Pharma's March 3, 2026 Temozolomide Capsules recall due to impurity issues and Sun Pharmaceutical's June 1, 2026 Fexofenadine Tablets recall for impurities risk.
How to tell if you have this one
Check your bottle for NDC 23155-116-01 and verify if it is one of two lots: Lot #18020994 (Expiry October 2015) or Lot #18021311 (Expiry November 2015). The product is a 100 ct bottle of Rx-only tablets manufactured for Heritage Pharmaceuticals Inc. in Eatontown, NJ.
Brand
Heritage Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Your Bottle
Verify if your medication matches NDC 23155-116-01 and one of the recalled lot numbers with the specified expiry dates.
Consult Your Doctor
Contact your healthcare provider to discuss whether you should continue taking this specific batch or switch medications.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “U.S. Nationwide including Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0436-2015 (March 25, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0436-2015 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.