Chiesi Recalls ZYFLO CR Tablets Due to Dissolution Failure
Chiesi USA is recalling ZYFLO CR (zileuton) extended-release tablets because they failed to meet dissolution specifications. The recall affects 2,118 bottles distributed nationwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a quality control failure (dissolution) without reported adverse health consequences, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Chiesi USA, Inc. is recalling ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles. The recall is being conducted because the product failed to meet dissolution specifications, resulting in an out-of-specification result for dissolution.
The affected product is identified by NDC 10122-902-12 and Lot 3171855, with an expiration date of 12/19. A total of 2,118 bottles were distributed nationwide in the United States.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12.
- Manufacturer
- Chiesi USA, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 2,118
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)
- Lots: 3171855
- Exp. 12/19
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Chiesi USA, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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