Reported Aug 3, 2022 · Terminated

Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box.…

Teva Pharmaceuticals USA 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: Teva Pharmaceuticals USA Inc · 400 Interpace Pkwy Bldg A · Parsippany, NJ · 07054-1120

Is this the product you have?

  • Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box
  • Manufactured byActavis Laboratories UT, Inc., Salt Lake City, US 84108, USA
  • Distributed byActavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30
Lot codes and dates
  • Lot
    • 1403180
    • EXP. 10/2022
Amount recalled
12354 cartons

Where it was sold

  • Nationwide

Why it was recalled

Superpotent Drug: Out of specification assay result was obtained during stability testing.

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 Mar 15, 2024 · Data as of Sep 19, 7:22 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.