Allergan Recalls INFeD Iron Dextran Injection Due to Iron Content Stability Issues
Allergan recalls INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml vials due to failed stability testing for iron content. This affects certain lots manufactured by Patheon Italia S.p.A. in Italy.
Lower-risk recall
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
Contact the company
What happened, in plain English
Allergan is recalling specific lots of INFeD iron dextran injection vials because stability testing showed the iron content may have degraded. This could lead to inconsistent dosing if used improperly. The recall applies to certain lots with specific expiration dates. Read more at govinfonow.com/recall/41022-allergan-recalls-infed-iron-dextran-injection-due-to-iron-content.
Source Summary by GovInfoNow · govinfonow.com/recall/41022-allergan-recalls-infed-iron-dextran-injection-due-to-iron-content · Updated October 7, 2026 · FDA enforcement record: FDA #D-0545-2018
Cite this page
“Allergan Recalls INFeD Iron Dextran Injection Due to Iron Content Stability Issues.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41022-allergan-recalls-infed-iron-dextran-injection-due-to-iron-content. Based on FDA recall #D-0545-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0545-2018%22&limit=1).
Why it’s dangerous
The product failed stability testing for iron content, meaning the actual iron concentration in the injection may be lower than labeled. This could result in underdosing if the medication is used as intended.
Who’s affected
Patients prescribed iron dextran injections for anemia treatment who have the specific lots listed in the recall. Healthcare providers administering the injections are also affected.
How to tell if you have this one
Check the NDC codes: 52544-931-07 for single vials or 52544-931-02 for cartons of 10 vials. The recall includes specific lots with expiration dates from February 2018 through May 2020.
- Brand
Allergan- Category
Drug
What to do — step by step
Check Product Lot Number
Look for the lot number on the vial or carton, which is listed in the recall (e.g., 15W05A, 16W02A, etc.).
Contact Healthcare Provider
If you have the recalled product, contact your doctor or pharmacist to discuss alternative treatments or return options.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall indicates the product failed stability testing for iron content, so it may not provide the correct dose. Do not use the recalled lots until a replacement is obtained.
Similar recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0545-2018 (December 13, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0545-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.