Testosterone Cypionate Injection

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.

What was recalled

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.

Affected NDCs 52536-0625-01 52536-0625-10

Compare with the code on your package — it is the most precise check available.

Drug: Testosterone

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

Product	Strength	Form & route	Labeler	Type
Testosterone Cypionate NDC 52536-0625	200 mg/mL	Injection Intramuscular	Wilshire Pharmaceuticals	Rx · CIII

Recalling firm: Azurity Pharmaceuticals, Inc.
NDC code: 52536-625-10
Origin: MA, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-0489-2023 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.