Why it was recalled
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Product description
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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0252-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 17, 2025
- FDA report date
- Mar 12, 2025
- Quantity
- 1535 Oral Syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Safecor Health, LLC
Original FDA data
Every field from FDA enforcement report D-0252-2025, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 96308
- Address
- 4060 Business Park Dr Ste B
- Code information
- 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.
- Postal code
- 43204-5047
- Report date
- Mar 12, 2025
- Product type
- Drugs
- Recall number
- D-0252-2025
- Classification
- Class II
- Recalling firm
- Safecor Health, LLC
- Product quantity
- 1535 Oral Syringes
- Reason for recall
- Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 17, 2025
- Initial firm notification
- Letter
- Center classification date
- Mar 5, 2025