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
- Hazard
- viscosity-defect
- manufacturing-defect
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.
Related recalls
Same brand · TESTOSTERONE
- ModerateTestosterone Gel 1% Recalled Due to Defective Container Side-Seal Allowing Leakage
FDA (Drugs) · 2025-12-10
- HighStrides Pharma Testosterone Gel Recalled Due to Benzene Contamination
FDA (Drugs) · 2025-04-02
- HighTestosterone Gel Recalled Nationwide Due to Benzene Contamination
FDA (Drugs) · 2025-04-02
- HighTestosterone Gel Recalled by Teva for Excessive Potency
FDA (Drugs) · 2024-08-28
- HighPrescription testosterone gel recalled due to out-of-specification potency
FDA (Drugs) · 2022-08-03
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27