Vital Care Compounder Recalls Testosterone Cypionate Due to Sterility Concerns
Vital Care Compounder is recalling 13 units of Testosterone Cypionate 200mg/ml because aluminum crimps may not fully seal the vials, compromising sterility.
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 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
Vital Care Compounder, LLC is recalling 13 units of Testosterone Cypionate 200mg/ml, 1ML MDV. The product was distributed in Mississippi. The specific lot number is 382331, with a use-by date of 12-11-16.
The recall was initiated due to a lack of assurance of sterility. The FDA notes that aluminum crimps do not fully seal the rubber stopper to the vial on all containers, which could compromise the sterility of the medication.
Consumers who have this product should stop using it and contact Vital Care Compounder, LLC for further instructions or a refund.
The recalled product
- Product
- TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS
- Manufacturer
- Vital Care Compounder, LLC
- Category
- Drug — Injectable Steroid
- Affected units
- 13
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#:382331
- Use by 12-11-16
Distribution
Distributed in 1 state:
Related recalls
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- 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
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- HighWell Care Compounding Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns
FDA (Drugs) · 2016-06-15
- ModerateVital Care Compounder Recalls Trypan Blue Vials Due to Sterility Concerns
FDA (Drugs) · 2016-07-06
- SevereTestosterone Cypionate Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereTestosterone Cypionate Injectable Recalled Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
- SevereTestosterone Cypionate Injection Recalled Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereRed Mountain Compounding Recalls Testosterone Cypionate Vials Due to Sterility Concerns
FDA (Drugs) · 2019-11-13