Recalls / Class II

Class IID-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.

Affected lot / code info

Lot #s: a) 24250093, Exp 03/07/2025; 24321592, Exp 04/04/2025; 24280320, Exp 03/27/2025; b) 24371268, Exp 04/19/2025; c) 24400519, Exp 04/07/2025; 24500768, Exp 06/24/2025; 25040972, Exp 07/25/2025.

Why it was recalled

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

Recalling firm

Firm

Safecor Health, LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

4060 Business Park Dr Ste B, Columbus, Ohio 43204-5047

Distribution

Quantity

1535 Oral Syringes

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2025-02-17

FDA classified

2025-03-05

Posted by FDA

2025-03-12

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0252-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.