Recall archive / FDA drug enforcement

Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY,... — FDA record D-0570-2024

Reported completed

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 26, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.
Reason: CGMP Deviations and Presence of Particulate Matter: Glass
Classification: Class II
Recalling firm: Medisca Inc.
Quantity: 113 bottles
Agency-reported status: Completed
Source record identifier: D-0570-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot #s: 202323/G, 202323/H, Exp. 07/31/2026

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide in the USA and Canada

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jul 10, 2024
Recall initiation date: Jun 26, 2024
Center classification date: Jun 28, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.