Reported Nov 17, 2021 · Terminated

Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141,…

Sun Pharmaceutical Industries 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: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620

Is this the product you have?

  • Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only
  • Manufactured forNorthstar Rx LLC Memphis, TN 38141
  • Manufactured bySun Pharmaceutical Industries Limited, India, NDC # 16714-075-01
Lot codes and dates
    • Lot # DNC1127A
    • exp. date 05/2023
Amount recalled
73,957 30-count bottles

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 1, 2022 · Data as of Sep 19, 6:38 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.