Medisca Budesonide Recall: FDA Class II

Why it was recalled

CGMP Deviations and Presence of Particulate Matter: Glass

Product description

Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.

Lot numbers, UPCs & expiration codes

Lot #s: 202323/G, 202323/H, Exp. 07/31/2026

Where it was sold

Nationwide in the USA and Canada

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0570-2024
Classification: Class II
Status: Completed
Recall initiated: Jun 26, 2024
FDA report date: Jul 10, 2024
Quantity: 113 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Medisca Inc.

Original FDA data

Every field from FDA enforcement report D-0570-2024, exactly as published.

Show all FDA fields

City: Irving
State: TX
Status: Completed
Country: United States
Event ID: 94868
Address: 6641 N Belt Line Rd Ste 130
Code information: Lot #s: 202323/G, 202323/H, Exp. 07/31/2026
Postal code: 75063-6001
Report date: Jul 10, 2024
Product type: Drugs
Recall number: D-0570-2024
Classification: Class II
Recalling firm: Medisca Inc.
Product quantity: 113 bottles
Reason for recall: CGMP Deviations and Presence of Particulate Matter: Glass
Voluntary / mandated: Voluntary: Firm initiated
Product description: Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.
Distribution pattern: Nationwide in the USA and Canada
Recall initiation date: Jun 26, 2024
Initial firm notification: Letter
Center classification date: Jun 28, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0570-2024, published Jul 10, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Medisca Budesonide Recall

Summary