Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe recall
FDA recall D-0252-2025 · initiated Feb 17, 2025
Safecor Health, LLC recalled Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe in Feb 2025 — an FDA Class II recall (D-0252-2025) because Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Another quality failure
A quality failure that does not fit the categories above.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1535 Oral Syringes
Details
- 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.
- Recalling company
- Safecor Health, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Feb 17, 2025
- FDA report date
- Mar 12, 2025
Frequently asked
- Was Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe recalled?
- Safecor Health, LLC recalled Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe in Feb 2025 — an FDA Class II recall (D-0252-2025) because Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe recalled?
- Per the FDA enforcement record, the reason for recall D-0252-2025 was: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
- Is a recalled Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — 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.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0252-2025.