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Class III · Lower riskActive recall

Testosterone

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #100068692, Exp.: 04/30/2027
Where it was soldU.S. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Defective Container - A defect in the side-seal which allows leakage of product.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byActavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
Brand nameTESTOSTERONE
Generic nameTESTOSTERONE
Active ingredient(s)TESTOSTERONE
Distributed by / forActavis Pharma, Inc., Parsippany, NJ 07054
NDC0591-3216-30
Show the full FDA record
Full product labelCarton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.
Recalling firmTeva Pharmaceuticals USA, Inc
DistributionU.S. Nationwide
Quantity15,944 cartons
Recall initiated2025-11-07
Report date2025-12-10
Recall completed
Recall numberD-0198-2026
ClassificationClass III
FDA statusOngoing
Origin on fileParsippany NJ United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.