Reported Nov 18, 2020 · Terminated

Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE,…

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

Is this the product you have?

    • Mesalamine Delayed-Release Tablets
    • USP 1.2 gram (Once-Daily)
    • 120 Tablets bottle
  • Rx Only Manufactured forAvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12
Lot codes and dates
  • Lots
    • 26085 Exp. 07/2021
    • 26426 Exp. 01/2022
    • 26983 Exp. 04/2022
    • 28647 Exp. 06/2022
Amount recalled
15,678 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications

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 Jun 2, 2023 · Data as of Sep 19, 8:06 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.