Testosterone Cypionate Injection Recalled for Manufacturing Defect
Azurity Pharmaceuticals is recalling Testosterone Cypionate Injection due to complaints that crystals fail to redissolve after warming and shaking, a manufacturing quality defect affecting specific lots nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable drug with a confirmed manufacturing defect (crystals not redissolving) that represents a risk-of-harm situation affecting medication quality and efficacy. No illnesses or injuries have been reported to date.
Plain-English summary
Azurity Pharmaceuticals, Inc. is recalling specific lots of Testosterone Cypionate Injection, USP 200 mg/mL due to complaints that crystals are not redissolving into solution after warming and shaking the vials. The issue represents a failure to meet current Good Manufacturing Practice (cGMP) standards for drug formulation and quality.
The recalled product includes 10 mL multiple-dose vials (NDC 52536-625-10) and 1 mL single-dose vials (NDC 52536-625-01), specifically lots #23804.034A and 23803.061A with an expiration date of September 2024. The product was distributed nationwide.
Patients and healthcare providers who have this medication should verify the lot number on the vial label. If the lot number matches one of the recalled lots, patients should contact their healthcare provider before using any remaining doses to discuss alternative treatment options.
The recalled product
- Product
- TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
- Brand
- TESTOSTERONE CYPIONATE
- Manufacturer
- Azurity Pharmaceuticals, Inc.
- Category
- Drug
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)
- Lot #23804.034A
- 23803.061A
- Exp 9/2024
Distribution
Distributed nationwide across the United States.
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