FDA Issues a Class II Recall of Ferrous Sulfate Oral Syringes

Safecor Health, LLC has issued a voluntary nationwide recall of ferrous sulfate 7.5 mg iron/0.5 mL oral syringes due to a defective delivery system that may cause leakage after repackaging into unit-dose syringes. The recall affects 1535 oral syringes across multiple lots (24250093, 24321592, 24280320, 24371268, 24400519, 24500768, and 25040972) with expiration dates ranging from March 2025 to July 2025. The recalled product, originally manufactured by Akron Pharma and repackaged by Safecor Health, was distributed across the US. The recall was initiated on February 17, 2025, and classified as Class II by the US Food and Drug Administrations (FDA), indicating that while adverse health consequences are unlikely, the product’s defect could lead to inaccurate dosing or contamination.

The recall was triggered by observed leakage in the oral syringes, which may result in potential dosing inconsistencies or reduced efficacy of the medication. While no adverse events have been reported, pharmacists and health care providers are advised to discontinue use of the affected syringes and follow return instructions provided in the recall notification. Customers were informed via letter, and the recall remains ongoing. No official press release has been issued by Safecor Health regarding this recall.

Ferrous sulfate is an iron supplement used to prevent and treat iron deficiency anemia in infants, children, and adults. Ensuring accurate dosing is critical, particularly in pediatric and anemic patients who require precise supplementation to avoid under- or overdosing. Pharmacists should check their inventory and secure alternative products as needed. Any adverse reactions or quality concerns should be reported to the FDA MedWatch program.