Allergan Recalls Iron Dextran Injection Due to Stability Failures
Allergan is recalling INFeD (Iron Dextran Injection USP) because stability testing showed the product did not meet specifications for iron content.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Allergan is voluntarily recalling INFeD (Iron Dextran Injection USP), a prescription-only injectable medication. The recall involves 163,694 cartons of the product, which was distributed nationwide in the United States. The product is packaged in single-dose vials and cartons of ten vials.
The recall was initiated because product stability testing results did not meet specifications for iron content. The affected lots have expiration dates ranging from February 2018 to June 2020.
Healthcare providers and patients should stop using the recalled product and contact their healthcare provider for further instructions. Consumers should not use the product if they have it in their possession.
The recalled product
- 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
- Manufacturer
- ALLERGAN
- Category
- Drug — Injectable Medication
- Affected units
- 163,694
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · ALLERGAN
See all →- ModerateAllergan Recalls INFed Iron Dextran Injection for Stability Failure
FDA (Drugs) · 2018-12-05
- LowAllergan Recalls NORCO Tablets Due to Missing Controlled Substance Labeling
FDA (Drugs) · 2018-02-21
- ModerateAllergan Recalls One Lot of Viokace Tablets Due to Stability Testing Failures
FDA (Drugs) · 2018-01-17
Same hazard · stability failure
See all →- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateVasocaine lidocaine spray recalled because stability data does not support expiry
FDA (Drugs) · 2026-03-11
- ModerateZone 1 lidocaine cream recalled because stability data does not support expiry
FDA (Drugs) · 2026-03-11
- ModerateZone 2 lidocaine cream recalled because stability data does not support expiry
FDA (Drugs) · 2026-03-11
- ModerateCiclopirox shampoo recalled after failing impurity specifications at eighteen months
FDA (Drugs) · 2025-12-24