Reported Mar 8, 2023 · Terminated

Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b)…

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, 1 mg, Rx Only
  • Packaged ina) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b) 500-count bottle NDC 16729-001-16 UPC 3 16729 00116 8
  • Manufactured forAccord Healthcare, Inc., Durham, NC 27703
  • Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Lot codes and dates
  • Batches
    • a) R2000166
    • Exp. Date 4/30/2023
    • P2003528 Exp. Date 6/30/2023
    • P2005451 Exp. Date 8/31/2023
    • P2005438 Exp. Date 8/31/2023
    • P2005436 Exp. Date 8/31/2023
    • P2005437 Exp. Date 8/31/2023
    • P2005452 Exp. Date 8/31/2023
    • P2006055 Exp. Date 9/30/2023
    • P2101782 Exp. Date 2/28/2024
    • P2101783 Exp. Date 2/28/2024
    • P2101781 Exp. Date 2/29/2024
    • P2102171 Exp. Date 2/29/2024
    • P2101844 Exp. Date 3/31/2024
    • P2101846 Exp. Date 3/31/2024
    • P2101845 Exp. Date 3/31/2024
    • b) P2006510 Exp. Date 11/30/2023
    • P2100975 Exp. Date 1/31/2024
    • P2100625 Exp. Date 1/31/2024
    • P2101778 Exp. Date 2/29/2024
    • P2101779 Exp. Date 2/29/2024
    • P2103021 Exp. Date 4/30/2024
    • P2103020 Exp. Date 4/30/2024
    • R2100657 Exp. Date 5/31/2024
    • R2100656 Exp. Date 5/31/2024
    • R2100658 Exp. Date 5/31/2024
    • P2104735 Exp. Date 7/31/2024
    • P2104739 Exp. Date 7/31/2024
    • P2104737 Exp. Date 7/31/2024
    • P2104738 Exp. Date 7/31/2024
    • P2106260 Exp. Date 9/30/2024
    • P2107384 Exp. Date 9/30/2024
    • R2200045 Exp. Date 12/31/2024
    • R2200046 Exp. Date 12/31/2024
    • R2200054 Exp. Date 12/31/2024
    • R2200055 Exp. Date 12/31/2024
    • R2200057 Exp. Date 12/31/2024
    • R2200058 Exp. Date 12/31/2024
    • R2200053 Exp. Date 12/31/2024
    • R2200059 Exp. Date 12/31/2024
    • R2200056 Exp. Date 12/31/2024
    • P2201929 Exp. Date 2/28/2025
    • R2200663 Exp. Date 4/30/2025
    • P2203518 Exp. Date 5/31/2025
    • R2200897 Exp. Date 6/30/2025
    • R2200898 Exp. Date 6/30/2025
    • R2200899 Exp. Date 6/30/2025
    • P2205528 Exp. Date 8/31/2025
Amount recalled
469,944 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, 6:39 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.