FDA recall D-0252-2025

Product

Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 69618007059.

Reason for recall

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2025-02-17

Report date

2025-03-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0252-2025