Reported Aug 17, 2022 · Terminated

Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC…

AVKARE 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: AVKARE Inc. · 615 N 1st St · Pulaski, TN · 38478-2403

Is this the product you have?

  • Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only
  • Manufactured for
    • AvKARE
    • Inc. Pulaski
    • TN 38478
    • NDC 42291-367-10
    • UPC 3 42291 36710 4
Lot codes and dates
    • Lot #: 42581 Exp. 12/2024
    • 42484 Exp. 11/2024
    • 41204 Exp. 05/2024
    • 38723 Exp. 02/2023
    • 37623 Exp. 10/2022
Amount recalled
8328 bottles

Where it was sold

  • Nationwide

Why it was recalled

Labeling: Label Error on Declared Strength

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

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 30, 2024 · 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.