UnratedDrug recall · FDA · Published August 11, 2021
Granules USA recalls Naproxen 220mg tablets due to manufacturing deviations
Granules USA recalls Naproxen Sodum Tablets 220mg (caplet) manufactured by Granules India Limited due to CGMP deviations. Consumers should contact the manufacturer for details.
“Granules USA recalls Naproxen 220mg tablets due to manufacturing deviations.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35982-granules-usa-recalls-naproxen-220mg-tablets-due-to-manufacturing-deviations. Based on FDA recall #D-0777-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0777-2021%22&limit=1).
The Food and Drug Administration announced on August 11, 2021, that Granules USA, Inc. voluntarily recalled Naproxen Sodium Tablets USP 220 mg due to Current Good Manufacturing Practice (CGMP) deviations.
Manufacturer: 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; 7620060a
Quantity: 11,450,000 tablets
Distribution: New York
The hazard
The recall was initiated because the product did not meet Current Good Manufacturing Practice (CGMP) standards.
Context
GovInfoNow's records show that Granules Pharmaceuticals issued a recall for Trazodone 50mg tablets on January 26, 2026, due to foreign tablets being found. Other recent recalls of similar products include Amgen's Sensipar 60mg tablet recall on June 4, 2026, due to manufacturing deviations and Shoolin Pharma Chem's Sildenafil recall on August 3, 2026, following FDA inspection findings.
How to tell if you have this one
Check for the product name 'Naproxen Sodum Tablets USP 220 mg (Caplet)' with NDC code 62207-762-36 or 7620060a. The tablets were manufactured by Granules India Limited in Telangana, India.
Brand
Granules USA
Category
Drug
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Granules USA, Inc. for specific instructions on how to handle the recalled product.
Where it went and when
Where it was distributed
Distributed in New York.
Listed by the agency
Not listed
FDA distribution: “NY” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New York.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0777-2021 (August 11, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0777-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.