Testosterone Gel 1% Recalled Due to Defective Container Side-Seal Allowing Leakage
Teva Pharmaceuticals recalls Testosterone Gel 1% due to a defect in the container side-seal that allows product leakage. The recall affects lot #100068692 (expiration 04/30/2027) consisting of approximately 15,944 cartons distributed nationwide.
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: This is an FDA Class III recall for a container packaging defect. The side-seal defect allows product leakage, affecting container integrity but not involving contamination or an inherent drug safety hazard. Per the severity rubric, Class III recalls without reported direct safety incidents typically score as Moderate (2).
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling Testosterone Gel 1% (NDC 0591-3216-30) due to a defect in the side-seal of product containers that allows leakage.
The affected product is Testosterone Gel 1%, containing 2.5 grams per unit-dose packet (NDC 0591-3216-17). The recall involves lot #100068692 with an expiration date of 04/30/2027. Approximately 15,944 cartons were distributed nationwide in the United States.
The defect is a side-seal defect in the product containers, which allows leakage of the product. This affects the integrity of the packaging.
The recalled product
- Product
- TESTOSTERONE (TESTOSTERONE)
- Brand
- TESTOSTERONE
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug — Topical Prescription
- Hazard
- container-defect
- leakage
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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