Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Testosterone Cypionate Injection Recalled by Azurity Pharmaceuticals, Inc. Due to cGMP: complaints of crystals not redissolving into solution...

Date: February 15, 2023
Company: Azurity Pharmaceuticals, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Azurity Pharmaceuticals, Inc. directly.

Affected Products

Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, Mfd for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328.

Quantity: a) 16,471 vials; b) 43,096 vials

Why Was This Recalled?

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Azurity Pharmaceuticals, Inc.

Azurity Pharmaceuticals, Inc. has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report