December 2024 FDA Recall Metformin Er 500 Mg by Granules Pharmaceuticals Inc.
D-0192-2025 - Presence of Foreign Tablets/Capsules

This Class II drug recall was voluntarily initiated by Granules Pharmaceuticals Inc. on December 30, 2024 for the product Metformin Er 500 Mg. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed in Distributor in OH. and the recall is currently terminated.

Recall Number: D-0192-2025

Reason for Recall
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.
Initiated
12-30-2024
Reported
01-15-2025
Quantity
6,804 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96082
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Granules Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributor in OH.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2026
Product Description About Product Description
Full technical description of the product.
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

82009-117-10 Metformin Er 500 Mg
82009-118-01 Metformin Er 750 Mg