Injectable Testosterone Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling 520 vials of Ultratest testosterone injectable due to lack of sterility assurance. The recall affects distribution nationwide in the USA, Puerto Rico, and US Virgin Islands.
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 recall for lack of sterility assurance in injectable testosterone product. Although no illnesses or injuries are reported, injectable medications lacking sterility assurance present an inherent risk of serious bacterial infection and meet the criteria for High severity as risk-of-harm products.
Plain-English summary
Olympia Compounding Pharmacy is recalling Ultratest Testosterone Cypionate 160 mg/mL and Testosterone Propionate 40 mg/mL multi-dose vials (10 mL size, NDC 73198-0058-10). Affected lot numbers are J24014 and J24114, with a beyond-use date of 10/14/2022.
The recall is being issued because the FDA determined there is a lack of assurance of sterility for the product.
A total of 520 vials are subject to this recall and were distributed nationwide in the United States, Puerto Rico, and the US Virgin Islands.
Patients who have received this product should contact their healthcare provider to discuss potential risks and appropriate follow-up. Healthcare providers should stop dispensing the affected lots and identify patients who may have received the product.
The recalled product
- Product
- Ultratest Testosterone Cypionate 160 mg/mL Testosterone Propionate 40 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0058-10
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- contamination
- infection-risk
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)
- Lots: J24014
- J24114 BUD: 10/14/2022
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
- ModeratePovi-One Povidone-Iodine 10% Topical Drug Recall for Sub Potency
FDA (Drugs) · 2026-07-01
- ModerateSensipar cinacalcet hydrochloride tablets recalled for CGMP deviations
FDA (Drugs) · 2026-07-01
- ModerateSensipar Cinacalcet Tablets Recalled Due to CGMP Deviations
FDA (Drugs) · 2026-07-01
- ModerateSensipar (Cinacalcet Hydrochloride) Tablets Recalled for CGMP Deviations
FDA (Drugs) · 2026-07-01