Medaus Recalls Testosterone Cypionate Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific vials of Testosterone Cypionate 25 mg/mL due to a lack of assurance of sterility. The affected product was distributed in the U.S., Japan, and New Zealand.
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 and involves a lack of assurance of sterility, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Medaus, Inc. is recalling 5 mL vials of Testosterone Cypionate 25 mg/mL with preservative (Benzyl Ethyl Alcohol 2%). The recall was initiated because of a lack of assurance of sterility for the product.
The affected product is identified by Lot # 160115-20 with a Beyond-Use Date of 07/13/16. The quantity involved is 13 mL in vials. The product was distributed nationwide in the United States, as well as in Japan and New Zealand.
Consumers and healthcare providers should stop using the affected product and contact Medaus, Inc. or their healthcare provider for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- TESTOSTERONE CYP 25 MG/ML W/PRES (BENZYL ETOH 2%), 5ML Vials, MEDAUS PHARMACY
- Manufacturer
- Medaus, Inc.
- Category
- Drug — Injectable Steroid
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 #: 160115-20
- BUD: 07/13/16
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 88 recalled by Medaus, Inc. 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 88 products in this recall →Related recalls
Same manufacturer · Medaus, Inc.
See all →- SevereMedaus Recalls Testosterone Cypionate Vials Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SevereMedaus Recalls Testosterone Cypionate Vials Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SevereMedaus Recalls Taurine Vials Due to Lack of Sterility Assurance
FDA (Drugs) · 2016-07-20
- SevereMedaus Recalls Lipo-Injection Vials Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-07-20
- SevereMedaus Recalls B-Complex Vials Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
Same hazard · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15