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Drug FDA Class II Ongoing Contamination / non-sterility

TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01

Advanced Pharmaceutical Technology, Inc. Published Jan 21, 2026

Risk level

Class II

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

Severity score 50/100

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 Advanced Pharmaceutical Technology, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.

Hazards

Microbial contamination · primary

Affected products (1)

TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01

22,843 pellets

Code info: Lot #: P-22-3, Exp 06-2027

Affected areas

GeorgiaNew YorkPuerto RicoTexas

Timeline

  1. Initiated
    Oct 3, 2025
  2. Published
    Jan 21, 2026
Recall number
D-0258-2026
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.