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Drug FDA Class II Ongoing Sub/super-potent

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

Teva Pharmaceuticals USA, Inc Published Aug 28, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Teva Pharmaceuticals USA, Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Superpotent Drug

Hazards

Superpotency · primary

Affected products (1)

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

TESTOSTERONE · 7,080 unit dose packets

NDC: 0591-2924, 0591-2925, 0591-2926, 0591-2924-18, 0591-2925-32, 0591-2925-30, 0591-2926-25, 0591-2926-30
Code info: Lot #: 100042386, Exp. Date 06/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Aug 8, 2024
  2. Published
    Aug 28, 2024
Recall number
D-0637-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.