Testosterone Cypionate Injectable Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Testosterone Cypionate 40 mg/ml Injectable due to FDA inspection findings regarding sterility assurance.
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, which corresponds to a Severe rating under the rubric, particularly given the risk of sterility failure in an injectable medication.
Plain-English summary
The Compounding Pharmacy of America is recalling Testosterone Cypionate 40 mg/ml Injectable, 7 ml vials. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The recall covers all lots of the product distributed between November 2014 and May 2015. The distribution pattern is listed as nationwide. The specific lot code identified in the recall notice is 04152015@56, with a date of 10/12/2015.
Consumers and healthcare providers should check their inventory for this specific product and lot code. If the product is found, it should be returned to the pharmacy or supplier for credit or replacement. Patients should consult their healthcare provider regarding alternative treatment options if they have been using this product.
The recalled product
- Product
- Testosterone Cypionate 40 mg/ml Injectable, 5 Sesame, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- 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 (3)
- All lots distributed between November 2014 and May 2015
- 04152015@56
- 10/12/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 382 recalled by The Compounding Pharmacy of America 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 382 products in this recall →Related recalls
Same manufacturer · The Compounding Pharmacy of America
See all →- CriticalFDA Recalls Non-Sterile HCG and Methylcobalamin Injection Vials
FDA (Drugs) · 2018-02-21
- SevereFDA Recalls Morphine and Ropivacaine Compounded Solution Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereHydromorphone Solution Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereMorphine and Bupivacaine Solution Recalled for Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereMethylcobalamin Injectable Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
Same hazard · sterility failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22