Budesonide USP drug ingredient recalled for glass contamination
Medisca Inc. is recalling 113 bottles of Budesonide, USP (Micronized) 500 mg due to glass particulate matter contamination caused by manufacturing deviations. The product was distributed nationwide in the USA and Canada.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with confirmed glass particulate contamination, representing a risk-of-harm scenario. Although no illnesses or injuries have been reported, physical contamination in pharmaceutical products warrants a High severity rating per the rubric.
Plain-English summary
Medisca Inc., located in Plattsburgh, New York, is recalling 113 bottles of Budesonide, USP (Micronized), 500 mg (NDC: 38779-3097-00). The affected product is a white to off-white crystalline powder with lot numbers 202323/G and 202323/H, expiring July 31, 2026.
The recall was initiated due to the presence of glass particulate matter in the product resulting from Current Good Manufacturing Practice (CGMP) deviations during manufacturing. Glass contamination in pharmaceutical products poses a safety risk if the affected material is used in preparations for human administration.
The product was distributed nationwide in the United States and Canada. Healthcare facilities, pharmacies, and pharmaceutical manufacturers that have received this product should discontinue use and contact Medisca Inc. for return or disposal instructions.
The recalled product
- Product
- Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.
- Manufacturer
- Medisca Inc.
- Affected units
- 113
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #s: 202323/G
- 202323/H
- Exp. 07/31/2026
Distribution
Distributed nationwide across the United States.
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