Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavi
Summary
The FDA issued a Class III for Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose p by Teva Pharmaceuticals USA, Inc. Reason: Defective Container - A defect in the side-seal which allows leakage of product..
Details
Source
Drug Recall
External ID
D-0198-2026
Action Date
2025-12-10
Status
Ongoing
Category
drug
Product Description
Carton 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.
Lot/Code Info: Lot #100068692, Exp.: 04/30/2027
Quantity Affected: 15,944 cartons
Reason for Recall
Defective Container - A defect in the side-seal which allows leakage of product.
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-07
Company
Parsippany, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 51 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Teva Pharmaceuticals USA, Inc has 50 FDA actions in our database, including 50 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Teva Pharmaceuticals USA, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teva Pharmaceuticals USA, Inc have FDA actions?
Teva Pharmaceuticals USA, Inc has 50 FDA actions in our database, including 50 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0198-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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