Reported Sep 8, 2021 · Terminated

Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A,…

Granules USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Granules USA, Inc. · 35 Waterview Blvd Fl 3 · Parsippany, NJ · 07054-1200

Is this the product you have?

  • 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 codes and dates
  • 7620060a
Amount recalled
11,450,000 tablets

Where it was sold

Why it was recalled

CGMP Deviations

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 16, 2023 · Data as of Sep 19, 5:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.