Reported Apr 5, 2023 · Terminated

Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; 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
    • 2 mg Tablets
    • Rx Only
    • Packaged as a a) 30-count bottle
    • NDC 61919-0488-30
    • b) 90-count bottle
    • NDC 61919-0448-90
  • Packaged and Distributed ByDirect Rx, Dawsonville, GA 30534
Lot codes and dates
  • a) [30 count bottles] Lot
  • expiry
    • 21JU2112
    • exp 9/30/2023 b) [90 count bottles] Lot
  • expiry
    • 22DE2113
    • exp 1/31/2024
    • 27JA2235
    • exp 3/31/2024
    • 05AP2224
    • exp 7/31/2024
    • 06AU2104
    • exp 1/31/2024
    • 08JU2215
    • exp 9/30/2024
    • 209AU2109
    • exp 1/31/2024
    • 15JU2113
    • exp 9/30/2023
    • 21FE2217
    • exp 4/30/2024
    • 21OC2115
    • exp 2/29/2024
    • 23JY2144
    • exp 1/31/2024
    • 25JU2124
    • exp 9/30/2023
    • 29AP2219
    • exp 7/31/2024
    • 07DE2128
    • exp 3/31/2024
Amount recalled
30 count: 12 bottles; 90 count: 253 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.

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 Direct Rx 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 Jun 17, 2024 · Data as of Sep 19, 7:20 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.