Pfizer Recalls Deferoxamine Mesylate Injection Due to CGMP Deviations
Pfizer is recalling 32,276 vials of Deferoxamine Mesylate for injection due to a failure to control impurities causing color change at the API stage.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text explicitly identifies this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Pfizer Inc. is recalling 32,276 vials of Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. The product is identified by Lot 51275DD and has an expiration date of 09/01/17. The recall covers vials distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm failed to control an impurity responsible for color change at the active pharmaceutical ingredient (API) stage. This is classified as an FDA Class III recall, which indicates a violation of CGMP or the Federal Food, Drug, and Cosmetic Act that is not likely to cause adverse health consequences.
Healthcare providers and patients should stop using the affected product and contact Pfizer or their local FDA office for further instructions. The product is intended for intravenous, intramuscular, or subcutaneous use and is available by prescription only.
The recalled product
- Product
- Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira, Inc., Lake Forest IL USA, NDC 0406-2336-10.
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Injectable Medication
- Hazard
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 (2)
- Lot: 51275DD
- Exp. 09/01/17
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Pfizer Inc.
See all →- HighSodium bicarbonate injection vials recalled for lack of assurance of sterility
FDA (Drugs) · 2025-08-27
- HighEpinephrine injection vials recalled for lack of assurance of sterility
FDA (Drugs) · 2025-08-27
- HighBicillin L-A 2.4 million unit vials recalled after particulates found
FDA (Drugs) · 2025-08-06
- HighBicillin L-A penicillin vials recalled after particulates found during visual inspection
FDA (Drugs) · 2025-08-06
- ModerateDobutamine Injection Recall Due to Discoloration and Cracked Vials
FDA (Drugs) · 2025-07-02
Same hazard · cgmp deviation
See all →- SevereBaxter Recalls Vasopressin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateLexia LLC Recalls Broadway Joe's Pain Cream Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
Similar recalls
- SeverePfizer Recalls Dopamine Hydrochloride Injection Due to Sterility Concerns
FDA (Drugs) · 2026-09-23
- ModeratePfizer Recalls Clindamycin Injection Due to Impurity Specification Failures
FDA (Drugs) · 2019-04-10
- CriticalPfizer Recalls Vancomycin Hydrochloride Vials Due to Glass Particulate Matter
FDA (Drugs) · 2017-12-27
- LowLupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations
FDA (Drugs) · 2016-06-08
- SeverePfizer Recalls Daptomycin Injection Due to Microbial Contamination
FDA (Drugs) · 2018-08-08
- SeverePfizer Recalls Meropenem Injection Due to Loss of Sterility Assurance
FDA (Drugs) · 2018-10-31