Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Med… recall
FDA recall D-0570-2024 · initiated Jun 26, 2024
Medisca Inc. recalled Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline p… in Jun 2024 — an FDA Class II recall (D-0570-2024) because CGMP Deviations and Presence of Particulate Matter: Glass.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations and Presence of Particulate Matter: Glass
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: 113 bottles
Details
- Product
- Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.
- Recalling company
- Medisca Inc.
- Classification
- Class II
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA and Canada
- Initiated
- Jun 26, 2024
- FDA report date
- Jul 10, 2024
Frequently asked
- Was Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline p… recalled?
- Medisca Inc. recalled Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline p… in Jun 2024 — an FDA Class II recall (D-0570-2024) because CGMP Deviations and Presence of Particulate Matter: Glass. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline p… recalled?
- Per the FDA enforcement record, the reason for recall D-0570-2024 was: CGMP Deviations and Presence of Particulate Matter: Glass
- Is a recalled Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline p… 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 Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline p… are affected?
- Distributed: Nationwide in the USA and Canada. The recall covers these lots — Lot #s: 202323/G, 202323/H, Exp. 07/31/2026. 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-0570-2024.