Metformin Er 750 Mg Tablet
FDA Recall NDC 82009-118
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Metformin Er 750 Mg (NDC 82009-118). A significant event, classified as Class II, was initiated on Dec 30, 2024 by Quallent Pharmaceuticals Health Llc. The reported reason for this action was: "Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Dec 30, 2024
Jan 15, 2025
6,804 bottles
Recall Profile & Regulatory Data
Event ID
96082
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Granules Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributor in OH.
Termination Date
Jan 15, 2026
Product Description
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10
Batch or Lot Expiration Information
Lot# : 4911311A, Exp. Date: 11/2025
Affected Packages Involved in this Recall
82009-117-10Product
82009-118-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
