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.

Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Recalled by Glenmark Pharmaceuticals Inc., USA Due to Lack of Assurance of Sterility

Date: August 27, 2021
Company: Glenmark Pharmaceuticals Inc., USA
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 Glenmark Pharmaceuticals Inc., USA directly.

Affected Products

Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32

Quantity: 28658 cartons

Why Was This Recalled?

Lack of Assurance of Sterility

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Glenmark Pharmaceuticals Inc., USA

Glenmark Pharmaceuticals Inc., USA has 139 total recalls tracked by RecallDetector.

Related Recalls

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