Testosterone Cypionate Injection

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

Why it was recalled

CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.

Cause type: Impurity / degradation

An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.

What was recalled

Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.

Affected NDC 62756-0015-40

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 62756-0015	200 mg/mL	Injection, Solution Intramuscular	Sun Pharmaceutical Industries, Inc.	Rx · CIII

Recalling firm: Sun Pharmaceutical Industries INC
NDC code: 62756-015-40
Origin: NJ, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-1153-2022 · 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.