Testosterone Gel Recalled by Teva for Excessive Potency
Teva Pharmaceuticals recalls 7,080 packets of Testosterone Gel nationwide due to higher-than-labeled potency. Patients using the recalled product may receive unintended overdoses.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a superpotent drug creates genuine risk of overdose. No illnesses or hospitalizations are reported in the source, placing it in the 'risk-of-harm' category where injury has not yet been documented.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 7,080 unit-dose packets of Testosterone Gel 1.62% (Lot #100042386, expiration date 06/2025) due to superpotency. The product was distributed nationwide in the United States.
The testosterone gel contains a higher concentration of the active ingredient than labeled. Patients using this product may inadvertently receive doses higher than prescribed, potentially resulting in overdose symptoms such as elevated blood pressure, mood changes, or other effects associated with excessive testosterone exposure.
This recall affects patients who may have filled prescriptions for Testosterone Gel from the affected lot. Patients should contact their healthcare provider or pharmacist to determine if they received product from this lot and to discuss appropriate next steps.
Patients should not stop taking their testosterone therapy without consulting their healthcare provider. Instead, contact a pharmacy or doctor to confirm whether dispensed medication is from the recalled lot and obtain a replacement from an unaffected lot if necessary.
The recalled product
- Product
- TESTOSTERONE (TESTOSTERONE)
- Brand
- TESTOSTERONE
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug
- Affected units
- 7,080
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 #: 100042386
- Exp. Date 06/2025
Distribution
Distributed nationwide across the United States.
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