Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Naproxen Sodum Tablets USP 220 mg Recalled by Granules USA, Inc. Due to CGMP Deviations

Date: August 11, 2021
Company: Granules USA, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Granules USA, Inc. directly.

Affected Products

Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village, Dundigal-Gandimalsamma Monday, Medchai-Maikhajgir District - 500043, Telangana, INDIA. NDC 62207-762-36

Quantity: 11,450,000 tablets

Why Was This Recalled?

CGMP Deviations

Where Was This Sold?

This product was distributed to 1 state: NY

Affected (1 state)Not affected

About Granules USA, Inc.

Granules USA, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report