Testosterone gel packets recalled over a side-seal defect allowing leakage
Teva Pharmaceuticals USA is recalling 15,944 cartons of Testosterone Gel 1% unit-dose packets because a defect in the side-seal allows leakage of product.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 under the rule that FDA Class III actions fall at 1 or 2: the record cites a packaging seal defect with no stated clinical consequence.
Plain-English summary
Testosterone Gel 1%, 2.5 grams per unit dose, CIII, supplied as 30 unit-dose packets per carton under NDC 0591-3216-30, is being recalled. The prescription product is manufactured by Actavis Laboratories, Inc. of Salt Lake City, Utah, and distributed by Actavis Pharma, Inc. of Parsippany, New Jersey.
The reason given in the enforcement record is a defective container: a defect in the side-seal which allows leakage of product.
The recall covers 15,944 cartons from lot 100068692, expiry 04/30/2027. Distribution was nationwide in the United States. The FDA has classified the action as Class III, its least serious category.
Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific carton is affected and arrange a replacement.
The recalled product
- Product
- TESTOSTERONE (TESTOSTERONE)
- Brand
- TESTOSTERONE
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug — Topical hormone
- Affected units
- 15,944
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #100068692
- Exp.: 04/30/2027
Distribution
Distributed nationwide across the United States.
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