D-0198-2026 Class III Ongoing
FDA drug recall D-0198-2026 was initiated by Teva Pharmaceuticals USA, Inc on Nov 7, 2025 and is designated Class III. Reason for recall: Defective Container - A defect in the side-seal which allows leakage of product. The recall status is ongoing. Affected quantity: 15,944 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 10, 2025
- Initiation Date
- Nov 7, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,944 cartons
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.
Reason for Recall
Defective Container - A defect in the side-seal which allows leakage of product.
Distribution Pattern
U.S. Nationwide
Code Information
Lot #100068692, Exp.: 04/30/2027
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0198-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026