Prescription Doxazosin Tablets Recalled for Manufacturing Deviations
Accord Healthcare is recalling Doxazosin 2 mg tablets distributed across the United States, Puerto Rico, and Canada due to manufacturing practice deviations identified during an FDA inspection.
What this means for you
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: This is an FDA Class II recall for manufacturing practice deviations with no reported illnesses, injuries, or deaths. The hazard is regulatory non-compliance rather than a specific product contamination or safety defect.
Plain-English summary
Accord Healthcare, Inc. is recalling Doxazosin Tablets USP 2 mg due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. The affected product was distributed in the United States, including Puerto Rico and Canada.
The recall affects approximately 69,122 bottles of Doxazosin 2 mg tablets across multiple batches with various expiration dates. Affected batch numbers include R2200401, R2200675, R2200676, R2201070, and R2200680. The product is identified by NDC numbers 16729-414-01 and 16729-414-17.
Consumers who have this medication should contact their pharmacy or healthcare provider for guidance. The FDA classifies this as a Class II recall.
The recalled product
- Product
- DOXAZOSIN (DOXAZOSIN)
- Brand
- DOXAZOSIN
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug
- Hazard
- manufacturing-deviation
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 (8)
- Batches: a) R2200401
- Exp. Date 5/31/2024
- R2200675
- R2200676 Exp. Date 11/30/2024
- R2201070
- Exp. Date 7/31/2025
- b) R2200680
- Exp. Date 9/30/2024
UPCs (2)
- 316729414012
- 316729414173
Distribution
Distribution scope not specified by the agency.
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