Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Quallent Metformin ER Tablets Recalled for Foreign Paracetamol Tablet Presence

Agency Publication Date: January 8, 2025
Share:
Sign in to monitor this recall

Summary

Granules Pharmaceuticals Inc. is recalling 6,804 bottles of Metformin Hydrochloride Extended-Release Tablets (500 mg), a prescription medication used for type 2 diabetes. The recall was initiated after a single Paracetamol 500 mg tablet was found inside a 1,000-count bottle of the Metformin. This product was manufactured for Quallent Pharmaceuticals Health LLC and distributed to a wholesaler in Ohio.

Risk

The presence of a foreign tablet means a patient could accidentally ingest Paracetamol (acetaminophen) instead of their intended medication. This poses a risk of liver toxicity or allergic reactions, particularly for individuals with liver impairment or those already taking the maximum daily dose of acetaminophen.

What You Should Do

  1. The recalled product is Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, sold in 1000-count bottles under the brand Quallent Pharmaceuticals (NDC 82009-117-10). Affected bottles are marked with Lot 4911311A and an expiration date of 11/2025.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer, Granules Pharmaceuticals Inc., for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Metformin Hydrochloride Extended-Release Tablets, USP (1000-count bottle)by Quallent Pharmaceuticals Health LLC
Variants: 500 mg, Extended-Release, Rx Only
Lot Numbers:
4911311A (Exp. 11/2025)
NDC:
82009-117-10

Manufactured by Granules India Limited for Quallent Pharmaceuticals Health LLC. Recall # D-0192-2025.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96082
Status: Resolved
Manufacturer: Granules Pharmaceuticals Inc.
Sold By: Distributor in OH
Manufactured In: India
Units Affected: 6,804 bottles
Distributed To: Ohio

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.