🔍 RecallPedia

Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 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 for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Class I - Dangerous
💊 Drugs Recalled: February 7, 2023 Accord Healthcare Prescription Drugs

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Accord Healthcare, Inc.
Reason for Recall:
CGMP Deviations: recalling drug products following an FDA inspection.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 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 for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0393-2023

Related Recalls

Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.

ACCORD HEALTHCARE

Class I - Dangerous

Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.

Sep 16, 2025 Prescription Drugs Nationwide View Details →