INFeD Iron Dextran Injection (Allergan) – Stability Failure (2017)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
ALLERGAN
Lot Codes / Batch Numbers
Lot# 15W05A, Exp.FEB-2018, 16W02A, Exp. DEC 2018, 16W05A, Exp. JAN-2019, 16W13A, Exp. APR-2019, 16W15A, 16W16A, 16W17A, Exp. MAY 2019, 16W18A, Exp. JUN 2019, 16W20A, 16W22A, Exp. SEP 2019, 17W01A, 17W02A, Exp. DEC-2019, 17W04A, 17W05A, Exp. JAN 2020, 17W09A, Exp. MAR-2020, 17W11A, 17W13A, Exp. MAY 2020, 17W14A, 17W15A, Exp. JUN 2020
Products Sold
Lot# 15W05A, Exp.FEB-2018; 16W02A, Exp. DEC 2018; 16W05A, Exp. JAN-2019; 16W13A, Exp. APR-2019; 16W15A, 16W16A, 16W17A, Exp. MAY 2019; 16W18A, Exp. JUN 2019; 16W20A, 16W22A, Exp. SEP 2019; 17W01A, 17W02A, Exp. DEC-2019; 17W04A, 17W05A, Exp. JAN 2020; 17W09A, Exp. MAR-2020; 17W11A, 17W13A, Exp. MAY 2020; 17W14A, 17W15A, Exp. JUN 2020
ALLERGAN is recalling INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) si due to Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026