Agency classClass IIOur severity:High FDA (Drugs)·D-0275-2024·Announced 2024-02-07

FDA Recalls Budesonide Extended-Release Tablets for Failed Dissolution

FDA has recalled approximately 10,672 bottles of Budesonide Extended-Release Tablets 9mg manufactured by Teva Pharmaceuticals due to failed dissolution specifications.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involving a manufacturing defect that creates risk of harm—failed dissolution can result in inadequate delivery of a medication patients depend on for treating serious inflammatory conditions. Although no illnesses or injuries have been reported, the defect affects core drug functionality.

Plain-English summary

Teva Pharmaceuticals USA, Inc. has issued a nationwide recall of Budesonide Extended-Release Tablets 9mg (NDC 0591-2510-30, Lot # 100047273, expiration 07/2025). The recall affects approximately 10,672 bottles in the 30-count package size. The tablets failed to meet FDA dissolution specifications, meaning they may not dissolve properly in the digestive system, potentially resulting in inadequate drug delivery.

Budesonide is a prescription corticosteroid used to treat inflammatory bowel diseases such as Crohn's disease. When tablets fail to dissolve as intended, patients may not receive the full therapeutic dose required for their condition. No illnesses or injuries have been reported at this time.

Patients taking this medication should contact their pharmacist or healthcare provider to determine whether their supply includes tablets from the recalled lot. Do not stop taking budesonide without consulting a healthcare professional, as abrupt discontinuation of corticosteroids can have serious health consequences. Patients with affected medication should obtain a replacement supply from their pharmacy.

The recalled product

Product: BUDESONIDE (BUDESONIDE)
Brand: BUDESONIDE
Manufacturer: Teva Pharmaceuticals USA, Inc
Category: Drug — Prescription Corticosteroid
Hazard: failed-dissolution
manufacturing-defect

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 (2)

Lot # 100047273
Exp. 07/2025

UPCs (1)

0305912510303

Distribution

Distributed nationwide across the United States.

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