🔍 RecallPedia

Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-count bottle NDC 16729-371-16, UPC 3 16729 37116 2; 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) P2002525, Exp. Date 4/30/2023; P2004442, Exp. Date 7/31/2023; P2005014, Exp. Date 8/31/2023; P2005015, Exp. Date 8/31/2023; P2005016, Exp. Date 8/31/2023; P2005825, Exp. Date 10/31/2023; P2005824, Exp. Date 10/31/2023; P2005826, Exp. Date 10/31/2023; P2100368, Exp. Date 12/31/2023; P2100444, Exp. Date 12/31/2023; P2101262, Exp. Date 2/29/2024; P2101263, Exp. Date 2/29/2024; P2200813, Exp. Date 1/31/2025; P2200814, Exp. Date 1/31/2025; b) P2002526, Exp. Date 4/30/2023; P2003781, Exp. Date 6/30/2023; P2003782, Exp. Date 6/30/2023; P2003783, Exp. Date 6/30/2023; P2004440, Exp. Date 7/31/2023; P2004441, Exp. Date 7/31/2023; P2005820, Exp. Date 10/31/2023; P2005821, Exp. Date 10/31/2023; P2005823, Exp. Date 10/31/2023; P2100077, Exp. Date 12/31/2023; P2100076, Exp. Date 12/31/2023; P2100078, Exp. Date 12/31/2023; P2100079, Exp. Date 12/31/2023; P2100080, Exp. Date 12/31/2023; P2100366, Exp. Date 12/31/2023; P2100442, Exp. Date 12/31/2023; P2100443, Exp. Date 12/31/2023; P2101265, Exp. Date 2/29/2024; P2101264, Exp. Date 2/29/2024; P2101718, Exp. Date 2/29/2024; P2108091, Exp. Date 11/30/2024; P2108092, Exp. Date 11/30/2024; P2108093, Exp. Date 11/30/2024; P2203589, Exp. Date 6/30/2025; P2203588, Exp. Date 6/30/2025; P2205379, 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:

Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-count bottle NDC 16729-371-16, UPC 3 16729 37116 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Product Codes/Lot Numbers:

Batches: a) P2002525, Exp. Date 4/30/2023; P2004442, Exp. Date 7/31/2023; P2005014, Exp. Date 8/31/2023; P2005015, Exp. Date 8/31/2023; P2005016, Exp. Date 8/31/2023; P2005825, Exp. Date 10/31/2023; P2005824, Exp. Date 10/31/2023; P2005826, Exp. Date 10/31/2023; P2100368, Exp. Date 12/31/2023; P2100444, Exp. Date 12/31/2023; P2101262, Exp. Date 2/29/2024; P2101263, Exp. Date 2/29/2024; P2200813, Exp. Date 1/31/2025; P2200814, Exp. Date 1/31/2025; b) P2002526, Exp. Date 4/30/2023; P2003781, Exp. Date 6/30/2023; P2003782, Exp. Date 6/30/2023; P2003783, Exp. Date 6/30/2023; P2004440, Exp. Date 7/31/2023; P2004441, Exp. Date 7/31/2023; P2005820, Exp. Date 10/31/2023; P2005821, Exp. Date 10/31/2023; P2005823, Exp. Date 10/31/2023; P2100077, Exp. Date 12/31/2023; P2100076, Exp. Date 12/31/2023; P2100078, Exp. Date 12/31/2023; P2100079, Exp. Date 12/31/2023; P2100080, Exp. Date 12/31/2023; P2100366, Exp. Date 12/31/2023; P2100442, Exp. Date 12/31/2023; P2100443, Exp. Date 12/31/2023; P2101265, Exp. Date 2/29/2024; P2101264, Exp. Date 2/29/2024; P2101718, Exp. Date 2/29/2024; P2108091, Exp. Date 11/30/2024; P2108092, Exp. Date 11/30/2024; P2108093, Exp. Date 11/30/2024; P2203589, Exp. Date 6/30/2025; P2203588, Exp. Date 6/30/2025; P2205379, Exp. Date 8/31/2025;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0416-2023

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 →