FDA Drugs recall ·
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg… recall
- Recall number
- D-0192-2025
- Date
- (initiated December 30, 2024)
- Company / brand
- Granules Pharmaceuticals Inc.
3701 Concorde Pkwy, Chantilly, VA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 6,804 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 4911311A, Exp. Date: 11/2025
Distribution
Distributor in OH.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0192-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.