CLASS II Drug recall · Reported 10 Jul 2024 · FDA Enforcement Report
Budesonide, USP (Micronized), 500 mg recalled by Medisca
Medisca is recalling Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, distributed nationwide in the US. The recall was initiated on 26 Jun 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0570-2024
- FDA event ID
- 94868
- Recalling firm
- Medisca, Irving, TX
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 26 Jun 2024
- FDA classified
- 28 Jun 2024
- Reported
- 10 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Inhalers & Asthma Medication
Timeline
| 26 Jun 2024 | Recall initiated by company | |
| 28 Jun 2024 | Classified by FDA | +2 days |
| 10 Jul 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations and Presence of Particulate Matter: Glass
Product as listed by the FDA
Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.
Where it was distributed
Nationwide in the USA and Canada
Questions about this recall
Why was it recalled?
CGMP Deviations and Presence of Particulate Matter: Glass
Which lots are affected?
Lot #s: 202323/G, 202323/H, Exp. 07/31/2026
Where was it sold?
Nationwide in the USA and Canada
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medisca
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|---|---|---|---|---|---|
| Drug | CLASS II | Bimatoprost powder, Bulk Ingredient, a) recalled by Medisca | Medisca | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Estriol, USP (Micronized), containers recalled by Medisca | Medisca | Potency & Assay | Nationwide |
| Drug | CLASS II | Aminocaproic Acid, USP (6-Aminohexanoic Acid) active recalled by Medisca | Medisca | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Estrone, USP Bulk, in a) 100 mgs recalled by Medisca | Medisca | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Estradiol, USP Bulk (Hemihydrate), in a) recalled by Medisca | Medisca | Manufacturing (CGMP) Deviations | Nationwide |
Other Budesonide recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 0.5mg/-dose ampules per, five recalledBudesonide | Cipla USA | Sterility | Nationwide |
| Drug | CLASS II | Budesonide Extended-Release Tablets 9mg recalledBudesonide | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Budesonide Extended-Release Tablets, 9 mg recalled | Golden State Medical Supply | Potency & Assay | IL |
| Drug | CLASS II | Budesonide Inhalation Suspension 0.25mg/, For Inhalation Only recalledBudesonide | Cipla | Sterility | Nationwide |