Reported Mar 8, 2023 · Terminated

Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500…

Accord Healthcare, 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: Accord Healthcare, Inc. · 1009 Slater Rd Ste 210B · Durham, NC · 27703-8446

Is this the product you have?

  • Glimepiride Tablets USP, 2 mg, Rx Only
  • Packaged ina) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 Tablets NDC 16729-002-16 UPC 3 16729 00216 5
  • Manufactured forAccord Healthcare, Inc., Durham, NC 27703
  • Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Lot codes and dates
  • Batches

    68 of 68 codes

    • a) R2000184
    • Exp. Date 4/30/2023
    • R2000183 Exp. Date 4/30/2023
    • P2002969 Exp. Date 5/31/2023
    • P2002970 Exp. Date 5/31/2023
    • P2005346 Exp. Date 8/31/2023
    • P2005847 Exp. Date 10/31/2023
    • P2006133 Exp. Date 10/31/2023
    • P2100682 Exp. Date 1/31/2024
    • P2102065 Exp. Date 3/31/2024
    • P2102067 Exp. Date 3/31/2024
    • P2102068 Exp. Date 3/31/2024
    • P2102070 Exp. Date 3/31/2024
    • R2100659 Exp. Date 5/31/2024
    • R2100660 Exp. Date 5/31/2024
    • P2103898 Exp. Date 6/30/2024
    • P2106000 Exp. Date 7/31/2024
    • R2101442 Exp. Date 9/30/2024
    • P2201160 Exp. Date 1/31/2025
    • P2200695 Exp. Date 1/31/2025
    • P2200694 Exp. Date 1/31/2025
    • b) P2005530
    • Exp. Date 9/30/2023
    • P2005531 Exp. Date 9/30/2023
    • P2005532 Exp. Date 9/30/2023
    • P2005533 Exp. Date 9/30/2023
    • P2005846 Exp. Date 10/31/2023
    • P2006594 Exp. Date 11/30/2023
    • P2100602 Exp. Date 1/31/2024
    • P2100603 Exp. Date 1/31/2024
    • P2100604 Exp. Date 1/31/2024
    • P2100605 Exp. Date 1/31/2024
    • P2101571 Exp. Date 2/29/2024
    • P2101572 Exp. Date 2/29/2024
    • P2102046 Exp. Date 3/31/2024
    • P2102047 Exp. Date 3/31/2024
    • P2102049 Exp. Date 3/31/2024
    • P2102050 Exp. Date 3/31/2024
    • P2102051 Exp. Date 3/31/2024
    • P2102052 Exp. Date 3/31/2024
    • P2103017 Exp. Date 4/30/2024
    • P2103018 Exp. Date 4/30/2024
    • P2103900 Exp. Date 6/30/2024
    • P2104436 Exp. Date 6/30/2024
    • P2105399 Exp. Date 7/31/2024
    • P2105400 Exp. Date 7/31/2024
    • P2106257 Exp. Date 9/30/2024
    • P2106258 Exp. Date 9/30/2024
    • P2106259 Exp. Date 9/30/2024
    • R2101443 Exp. Date 9/30/2024
    • R2101445 Exp. Date 9/30/2024
    • R2101444 Exp. Date 9/30/2024
    • R2200082 Exp. Date 12/31/2024
    • R2200080 Exp. Date 12/31/2024
    • R2200079 Exp. Date 12/31/2024
    • R2200081 Exp. Date 12/31/2024
    • P2200691 Exp. Date 1/31/2025
    • P2200692 Exp. Date 1/31/2025
    • P2200693 Exp. Date 1/31/2025
    • P2201499 Exp. Date 2/28/2025
Amount recalled
992,622 bottles

This recall covers 67 products

The agency filed one notice per product. You are reading one of them; the other 66 are below.

54 more are in the archive.

Where it was sold

Why it was recalled

CGMP Deviations: recalling drug products following an FDA inspection.

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.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 22, 2024 · Data as of Sep 19, 7:23 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.