Ergocalciferol recall
FDA recall D-0250-2025 · initiated Feb 17, 2025
Safecor Health, LLC recalled Ergocalciferol in Feb 2025 — an FDA Class II recall (D-0250-2025) 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: 3069 Oral Syringes
Details
- Product
- Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302.
- 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 Ergocalciferol recalled?
- Safecor Health, LLC recalled Ergocalciferol in Feb 2025 — an FDA Class II recall (D-0250-2025) 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 Ergocalciferol recalled?
- Per the FDA enforcement record, the reason for recall D-0250-2025 was: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
- Is a recalled Ergocalciferol 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 Ergocalciferol are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #: 24300812, Exp 01/31/2025; 24530836, Exp 07/19/2025. 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-0250-2025.