Ascorbic Acid Inj. Solution recall
FDA recall D-0040-2025 · initiated Sep 30, 2024
Staska Pharmaceuticals, Inc. recalled Ascorbic Acid Inj. Solution in Sep 2024 — an FDA Class I recall (D-0040-2025) because Presence of Particulate Matter: Presence of glass particulates.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Presence of Particulate Matter: Presence of glass particulates.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
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: 4773 vials
Details
- Product
- Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317
- Recalling company
- Staska Pharmaceuticals, Inc.
- Classification
- Class I
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Sep 30, 2024
- FDA report date
- Nov 13, 2024
Frequently asked
- Was Ascorbic Acid Inj. Solution recalled?
- Staska Pharmaceuticals, Inc. recalled Ascorbic Acid Inj. Solution in Sep 2024 — an FDA Class I recall (D-0040-2025) because Presence of Particulate Matter: Presence of glass particulates. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Ascorbic Acid Inj. Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0040-2025 was: Presence of Particulate Matter: Presence of glass particulates.
- Is a recalled Ascorbic Acid Inj. Solution 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. Most serious — a reasonable probability that use will cause serious harm or death. 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 Ascorbic Acid Inj. Solution are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #SP2400058, Exp 12/31/2024. 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-0040-2025.