The Recall Desk
SevereFDA (Drugs)·D-0459-2016·Announced 2015-12-09

Western Drug Recalls Testosterone Injections Due to Sterility Concerns

Western Drug Inc. is recalling 39 containers of Testosterone Injection due to a lack of assurance of sterility. The products were distributed nationwide in eight states.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the risk of infection associated with non-sterile injections.

Plain-English summary

Western Drug Inc. is recalling 39 containers of Testosterone Injection in concentrations of 100mg/mL, 200mg/mL, and 300mg/mL. The recall is being conducted because of a lack of assurance of sterility for the affected products.

The recalled products were distributed nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah. All lots of the product are included in this recall.

Consumers who have these products should stop using them and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Testosterone Injection 100mg/mL, 200mg/mL, 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
Affected units
39

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 (1)

  • all lots

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 91 recalled by Western Drug under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 91 products in this recall →