Granules Naproxen Sodum Tablets Recall: FDA Class II

Why it was recalled

CGMP Deviations

Product description

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

Lot numbers, UPCs & expiration codes

7620060a

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0777-2021
Classification: Class II
Status: Terminated
Recall initiated: Aug 11, 2021
FDA report date: Sep 8, 2021
Quantity: 11,450,000 tablets
Recall type: Voluntary: Firm initiated
Recalling firm: Granules USA, Inc.

Original FDA data

Every field from FDA enforcement report D-0777-2021, exactly as published.

Show all FDA fields

City: Parsippany
State: NJ
Status: Terminated
Country: United States
Event ID: 88475
Address: 35 Waterview Blvd Fl 3
Code information: 7620060a
Postal code: 07054-1200
Report date: Sep 8, 2021
Product type: Drugs
Recall number: D-0777-2021
Classification: Class II
Recalling firm: Granules USA, Inc.
Product quantity: 11,450,000 tablets
Termination date: Feb 16, 2023
Reason for recall: CGMP Deviations
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: NY
Recall initiation date: Aug 11, 2021
Initial firm notification: Letter
Center classification date: Aug 27, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0777-2021, published Sep 8, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Granules Naproxen Sodum Tablets 220 mg Recall

Summary