Testosterone Gel Recalled for Out-of-Specification Viscosity
Teva Pharmaceuticals recalls specific lots of Testosterone Gel 1.62% for failing viscosity specifications. Patients should contact their healthcare provider to discuss the recall and obtain unaffected medication.
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: FDA Class III recall for a manufacturing specification failure with no reported illnesses or injuries. Per the rubric, Class III recalls are typically scored 1 or 2; the voluntary precautionary nature of the recall places this at Moderate (2).
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling specific lots of Testosterone Gel 1.62% because the product failed viscosity specifications during quality control testing. The affected batch is Lot 100029472 (expiring February 29, 2024), distributed nationwide in cartons of 30 unit-dose packets under NDC 0591-2926-30. The manufacturer initiated this voluntary recall on November 10, 2023, and it was terminated on June 3, 2024.
No illnesses or injuries associated with this product have been reported. The out-of-specification viscosity is a manufacturing defect identified through the firm's quality control processes.
Patients currently using the recalled lot should discontinue use immediately and contact their healthcare provider to discuss alternative testosterone therapy options. For additional questions, contact your pharmacy or healthcare provider.
The recalled product
- Product
- TESTOSTERONE (TESTOSTERONE)
- Brand
- TESTOSTERONE
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug
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 #: 100029472
- Exp. 2/29/2024
Distribution
Distributed nationwide across the United States.
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