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 SUN PHARMACEUTICAL INDUSTRIES INC Due to CGMP Deviations: lots made with same active pharmaceutical...

Date: June 3, 2022
Company: SUN PHARMACEUTICAL INDUSTRIES 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 SUN PHARMACEUTICAL INDUSTRIES INC directly.

Affected Products

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.

Quantity: 97,450 vials

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About SUN PHARMACEUTICAL INDUSTRIES INC

SUN PHARMACEUTICAL INDUSTRIES INC has 86 total recalls tracked by RecallDetector.

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