Testosterone Gel recall
FDA recall D-0637-2024 · initiated Aug 8, 2024
Teva Pharmaceuticals USA, Inc recalled Testosterone Gel in Aug 2024 — an FDA Class II recall (D-0637-2024) because Superpotent Drug.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Superpotent Drug
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 7,080 unit dose packets
Details
- Product
- Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30
- Recalling company
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Product was distributed nationwide within the United States
- Initiated
- Aug 8, 2024
- FDA report date
- Aug 28, 2024
Frequently asked
- Was Testosterone Gel recalled?
- Teva Pharmaceuticals USA, Inc recalled Testosterone Gel in Aug 2024 — an FDA Class II recall (D-0637-2024) because Superpotent Drug. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Testosterone Gel recalled?
- Per the FDA enforcement record, the reason for recall D-0637-2024 was: Superpotent Drug
- Is a recalled Testosterone Gel dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Testosterone Gel are affected?
- Distributed: Product was distributed nationwide within the United States. The recall covers these lots — Lot #: 100042386, Exp. Date 06/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0637-2024.