Compounded Testosterone-Anastrozole Injectable Vials Recalled for Sterility Concerns
Tailor Made Compounding recalls 39 vials of a compounded injectable product for lack of assurance of sterility. Distribution was nationwide in the USA and Puerto Rico.
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: This is a Class II pharmaceutical recall for lack of assurance of sterility in a compounded injectable product. No illnesses or injuries are reported in the source, and the hazard is a manufacturing quality defect rather than confirmed contamination, placing it in the High category per the rubric.
Plain-English summary
Tailor Made Compounding (TMC Acquisition LLC) is recalling 39 vials of compounded injectable medication. The recalled product is Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, supplied in 10 mL vials for room temperature storage. Batch #10182113A1 with expiration date April 2022 is affected.
The recall is being issued due to lack of assurance of sterility.
The product was distributed nationwide in the United States and Puerto Rico.
Persons who have received this product should stop use and contact Tailor Made Compounding or their healthcare provider for guidance on next steps.
The recalled product
- Product
- Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 mL-vial, Room Temperature, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Compounded Injectable
- Hazard
- 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)
- Batch #: 10182113A1
- Exp 4/16/2022.
Distribution
Distributed nationwide across the United States.
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
- ModerateGas-X Simethicone 125 mg softgels recall for incomplete labeling
FDA (Drugs) · 2026-05-27
- ModerateVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid
FDA (Drugs) · 2026-05-27