Testosterone Cypionate Injectable Recalled Due to Sterility Concerns
The Compounding Shop is recalling Testosterone Cypionate 200 mg/mL injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant risks such as sterility assurance in injectable drugs.
Plain-English summary
The Compounding Shop, Inc. is recalling Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded in St. Petersburg, Florida. The recall involves 1 vial of 6mL, 19 vials of 10mL each, and 1 vial of 40mL. The product was distributed in Florida, California, Minnesota, and Maine.
The recall was initiated following FDA inspection findings that raised concerns regarding quality control processes and the lack of assurance of sterility. The agency has classified this recall as Class II.
Consumers who have purchased this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
- Manufacturer
- THE COMPOUNDING SHOP, INC.
- Category
- Drug — Injectable Steroid
- Hazard
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 (1)
- All Lots
Distribution
Part of a larger recall action
This product is one of 25 recalled by THE COMPOUNDING SHOP, 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.
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