Testosterone Injectable Pellets Recalled for Sterility Assurance Issues
TESTO-100 CIII testosterone pellets are being recalled due to potential microbial contamination. The manufacturer could not ensure sterility of the product. Patients in affected regions should contact their healthcare provider.
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 drug recall involving potential microbial contamination of injectable sterile pellets. No illnesses or injuries have been reported, but this represents a risk-of-harm product where patient injury has not yet occurred, meeting the rubric criterion for Score 3.
Plain-English summary
Advanced Pharmaceutical Technology, Inc. is recalling TESTO-100 CIII, a testosterone replacement therapy product supplied as sterile pellets for subcutaneous implantation (10 pellets per carton, NDC# 57377-100-01).
The recall was issued because the manufacturer identified a lack of assurance of sterility in the product. Potential microbial contamination of the subcutaneous pellets could compromise patient safety.
The recalled product was distributed to patients in Georgia, New York, Texas, Puerto Rico, United Kingdom, Malta, and Greece. The affected lot is P-22-3, with an expiration date of June 2027, covering 22,843 pellets total.
Patients who received TESTO-100 CIII pellets from this lot should contact their healthcare provider immediately to discuss the recall and explore alternative treatments. Healthcare providers with affected inventory should stop dispensing the product and contact the manufacturer for additional instructions.
The recalled product
- Product
- 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
- Manufacturer
- Advanced Pharmaceutical Technology, Inc.
- Hazard
- microbial-contamination
- sterility-failure
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 #: P-22-3
- Exp 06-2027
Distribution
Distributed in 3 states:
- GA
- NY
- TX
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- ModerateGas-X Simethicone 125 mg softgels recall for incomplete labeling
FDA (Drugs) · 2026-05-27