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.

INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL) Recalled by ALLERGAN Due to Failed Stability Specifications: Product stability testing results did...

Date: December 13, 2017
Company: ALLERGAN
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 ALLERGAN directly.

Affected Products

INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (NDC 52544-931-07), b) carton of 10 x 2 ml Single Dose Vials (NDC 52544-931-02) Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, Manufactured by: Patheon Italia S.p.A. Ferentino, Italy 03013.

Quantity: 163,694 cartons

Why Was This Recalled?

Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About ALLERGAN

ALLERGAN has 4 total recalls tracked by RecallDetector.

Related Recalls

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