Ferrous Sulfate Oral Syringes Recalled Due to Leakage Defect
Safecor Health is recalling 1535 Ferrous Sulfate 7.5 mg oral syringes distributed nationwide due to leakage observed during repackaging. The defective delivery system could result in improper dosing of the iron supplement.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with confirmed leakage defect in a unit-dose delivery system for an iron supplement. No illnesses or injuries have been reported, but the potential for improper dosing exists in a risk-of-harm product.
Plain-English summary
Safecor Health, LLC is recalling 1535 Ferrous Sulfate 7.5 mg Iron/0.5 mL oral syringes distributed nationwide. The product is an iron supplement supplied in unit-dose syringes, manufactured by Akron Pharma and packaged by Safecor Health (Columbus, OH).
The recall was initiated due to leakage observed after the oral solution was repackaged into unit-dose syringes. This defect in the delivery system could result in improper dosing of the iron supplement.
Affected lot numbers and their expiration dates are: 24250093 (03/07/2025), 24321592 (04/04/2025), 24280320 (03/27/2025), 24371268 (04/19/2025), 24400519 (04/07/2025), 24500768 (06/24/2025), and 25040972 (07/25/2025). The affected NDC codes are 71399748005, 39328055750, and 69618007059.
The recalled product
- 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.
- Manufacturer
- Safecor Health, LLC
- Category
- Drug — Iron Supplement
- Hazard
- leakage
- improper-dosing
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 (14)
- 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.
Distribution
Distributed nationwide across the United States.
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