Prescription testosterone gel recalled due to out-of-specification potency
Teva Pharmaceuticals is recalling testosterone gel lot 1403180 after stability testing revealed out-of-specification assay results indicating superpotency. The affected 12,354 cartons were distributed nationwide.
What this means for you
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 for superpotent testosterone gel. Although no illnesses or injuries have been reported, the excessive potency of a prescription hormone medication poses a potential risk of serious adverse health effects to patients. This meets the High severity criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Teva Pharmaceuticals USA Inc is recalling Testosterone Gel 1% (25 mg per 2.5 g dose), supplied in 30-unit-dose packets per box. The affected lot is 1403180 with an expiration date of 10/2022.
The recall was initiated following out-of-specification assay results obtained during stability testing. These results indicate that the product is superpotent, meaning it contains a higher potency than the label specifies. The FDA has classified this as a Class II recall.
Approximately 12,354 cartons of the affected lot were distributed nationwide in the United States.
Persons who have this product should consult their healthcare provider or pharmacist regarding this recall.
The recalled product
- Product
- TESTOSTERONE (TESTOSTERONE)
- Brand
- TESTOSTERONE
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Category
- Drug
- Hazard
- Affected units
- 12,354
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: 1403180
- EXP. 10/2022
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · TESTOSTERONE
- ModerateTestosterone gel packets recalled over a side-seal defect 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
- ModerateTestosterone Gel Recalled for Out-of-Specification Viscosity
FDA (Drugs) · 2023-12-06
Same manufacturer · Teva Pharmaceuticals USA Inc
See all →- SevereOctreotide Acetate Injectable Suspension Recalled Due to Sterility Assurance
FDA (Drugs) · 2026-05-13
- ModerateClaravis isotretinoin 10 mg capsules recalled for out-of-specification impurity
FDA (Drugs) · 2026-04-29
- ModerateTeva clonidine 0.2 mg patches recalled over unapproved raw material use
FDA (Drugs) · 2026-04-15
- HighTeva isotretinoin 30 mg capsules recalled as superpotent and subpotent
FDA (Drugs) · 2026-04-15
- HighTeva isotretinoin 40 mg capsules recalled as superpotent and subpotent
FDA (Drugs) · 2026-04-15
Same hazard · superpotency
See all →- HighAripiprazole 10 mg tablets recalled after testing superpotent in one lot
FDA (Drugs) · 2025-09-24
- ModerateHYDROmorphone Hydrochloride 50 mg Cassettes Recalled for Superpotency
FDA (Drugs) · 2025-04-30
- HighLevothyroxine Sodium Tablets Recalled Nationwide for Potency Variance
FDA (Drugs) · 2024-12-18
- HighLevothyroxine Sodium Tablets Recalled for Subpotent and Superpotent Content
FDA (Drugs) · 2024-12-18
- ModerateTriamcinolone Acetonide Cream USP Recalled for Out-of-Specification Potency Variance
FDA (Drugs) · 2024-11-27