INFed Iron Dextran (Allergan) – Stability Failure (2018)
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 2 mL Sterile Single Dose Vial, Mfd by Patheon Italia S.p.A. Ferentino, Italy NDC 52544-931-07
Brand
ALLERGAN
Lot Codes / Batch Numbers
Lot Numbers: 16W06A, 16W07A, 16W08A, exp. date 02/2019, 16W09A, 16W10A, exp. date 03/2019, 16W11A, 16W14A, exp. date 04/2019, 16W21A, exp. date 09/2019, 16W23A, exp. date 11/2019, 17W10A, exp. date 04/2020, 17W12A, exp. date 05/2020, 17W16A, 17W18A, exp. date 06/2020, 17W22A, exp. date 08/2020
Products Sold
Lot Numbers: 16W06A, 16W07A, 16W08A, exp. date 02/2019; 16W09A, 16W10A, exp. date 03/2019; 16W11A, 16W14A, exp. date 04/2019; 16W21A, exp. date 09/2019; 16W23A, exp. date 11/2019; 17W10A, exp. date 04/2020; 17W12A, exp. date 05/2020; 17W16A, 17W18A, exp. date 06/2020; 17W22A, exp. date 08/2020
ALLERGAN is recalling INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL due to Failed Stability Specification: out of specification 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 Specification: out of specification 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