Reported Mar 8, 2023 · Terminated

Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; 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?

  • Tadalafil Tablets, USP, 2.5 mg Rx Only
  • Packaged as
    • a) 30-count bottle NDC 16729-369-10
    • UPC 3 16729 36910 7
    • b) 500-count bottle NDC 16729-369-16
    • UPC 3 16729 36916 9
  • Manufactured forAccord Healthcare, Inc., Durham, NC 27703
  • Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
Lot codes and dates

7 of 7 products

Products covered by this recall
#Product as published
1P2002522, Exp. Date 4/30/2023
2P2005817, P2005816, Exp. Date 10/31/2023
3P2203687, Exp. Date 6/30/2025
4P2002521, Exp. Date 4/30/2023
5P2005818, Exp. Date 10/31/2023
6P2100075, Exp. Date 12/31/2023
7P2100996, P2100997, P2100998, P2100999, Exp. Date 1/31/2024
Amount recalled
36,773 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.

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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, 8:08 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.