FDA Recalls Testosterone Cypionate Vials Due to Sterility Concerns
Right Value Drug Stores LLC is recalling 4,675 vials of compounded Testosterone Cypionate due to a lack of 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 FDA classified this recall as Class II, citing a lack of sterility assurance for an intramuscular compounded drug. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Right Value Drug Stores LLC is recalling 4,675 vials of Testosterone Cypionate, 200 mg/mL, for intramuscular use. The product is packaged in 5 mL and 30 mL vials and was distributed nationwide in the United States.
The recall was initiated because of a lack of sterility assurance for the compounded drug. The source text does not report any illnesses, injuries, or deaths associated with the use of these vials.
Consumers and healthcare providers should stop using the recalled vials and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Testosterone Cypionate, 200 mg/mL, packaged in a) 5 mL vials (NDC 73271-1225-1) and b) 30 m vials ( NDC 73271-1226-2) This Is A Compounded Dug, Intramuscular Use, Office Use Only, 8400 Esters Blvd, STE 190, Irving, TX 75063.
- Manufacturer
- Right Value Drug Stores LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 4,675
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 (20)
- a) Lot 10212025@3
- BUD 10/21/2026
- 10292025@4
- BUD 10/29/2026
- 10282025@6
- BUD: 10/29/2026
- 12012025@1
- BUD: 12/01/2026
- 04072026@1
- BUD: 04/01/2027
- 05262026@3
- BUD 05/08/2027
- 05262026@7
- BUD 11/17/2026
- 05272026@1
- 05272026@2
- BUD: 11/22/2026
- 07032026@1
- 07022026@1
- BUD: 05/08/2027
Distribution
Distributed nationwide across the United States.
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