Reported Mar 8, 2023 · Terminated

Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 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, 20 mg, Rx Only
  • Packaged as
    • a) 30-count bottle NDC 16729-372-10
    • UPC 3 16729 37210 7
    • b) 500-count bottle NDC 16729-372-16
    • UPC 3 16729 37216 9
  • Manufactured forAccord Healthcare, Inc., Durham, NC 27703
  • Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
Lot codes and dates

64 of 64 products

Products covered by this recall
#Product as published
1P2002461, Exp. Date 4/30/2023
2P2002457, Exp. Date 4/30/2023
3P2002460, Exp. Date 4/30/2023
4P2002464, Exp. Date 4/30/2023
5P2002463, Exp. Date 4/30/2023
6P2002462, Exp. Date 4/30/2023
7P2002465, Exp. Date 4/30/2023
8P2003153, Exp. Date 5/31/2023
9P2003155, Exp. Date 5/31/2023
10P2003156, Exp. Date 5/31/2023
11P2003154, Exp. Date 5/31/2023
12P2003152, Exp. Date 5/31/2023
13P2003157, Exp. Date 5/31/2023
14P2003158, Exp. Date 5/31/2023
15P2003159, Exp. Date 5/31/2023
16P2003162, Exp. Date 5/31/2023
17P2003160, Exp. Date 5/31/2023
18P2003778, Exp. Date 6/30/2023
19P2003779, Exp. Date 6/30/2023
20P2004315, Exp. Date 6/30/2023
Amount recalled
613,553 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.

Free recall alerts

Get alerted about new Accord Healthcare, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

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, 8:06 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.