Reported Apr 5, 2023 · Terminated

Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC…

Direct Rx

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: Direct Rx · 94 Worldwide Dr · Dawsonville, GA · 30534-6828

Is this the product you have?

    • Glimepiride
    • USP
    • 1 mg Tablets
    • Rx Only
    • Packaged as a a) 30-count bottle
    • NDC 61919-0723-30
    • b) 90-count bottle
    • NDC 61919-0723-90
  • Packaged and Distributed ByDirect Rx, Dawsonville, GA 30534
Lot codes and dates
  • a) [30 count bottles] Lot
  • expiry
    • 07MA2208
    • exp 5/31/2024 b) [90 count bottles] Lot
  • expiry
    • 09AU2128
    • exp 1/31/2024
    • 28JY2102
    • exp 1/31/2024
    • 06AU2103
    • exp 1/31/2024
    • 03JA2210
    • exp 1/31/2024
    • 14JY2114
    • exp 1/31/2024
    • 05NO2106
    • exp 2/29/2024
    • 13OC2118
    • exp 2/29/2024
    • 08DE2121
    • exp 2/29/2024
Amount recalled
30 count: 4 bottles; 90 count: 172 bottles

This recall covers 11 products

The agency filed one notice per product. You are reading one of them; the other 10 are below.

Where it was sold

  • Nationwide

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 Jun 17, 2024 · Data as of Sep 19, 8:04 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.