Reported Oct 17, 2018 · Terminated

Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India,…

InvaGen Pharmaceuticals, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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: InvaGen Pharmaceuticals, Inc. · 7 Oser Ave · Hauppauge, NY · 11788-3811

Is this the product you have?

    • Amlodipine Besylate USP 10 mg Tablets
    • 1000-count bottles
    • Rx Only
  • Manufactured byCipla Ltd., Verna Goa, India
  • Manufactured for
    • Cipla USA
    • Inc. 1560 Sawgrass Corporate Parkway
    • Suite 130
    • Sunrise FL 33323 UPC 369097128159
    • NDC 69097-128-15
Lot codes and dates
    • Lot #: GG80218
    • Exp. 12/2019
Amount recalled
2880 bottles

Where it was sold

  • Nationwide

Why it was recalled

Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new InvaGen Pharmaceuticals, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 13, 2021 · Data as of Sep 19, 8:07 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.