The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0387-2023·Announced 2023-03-08

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.

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: 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
Affected units
69,122

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

Distributed in 1 state:

Part of a larger recall action

This product is one of 67 recalled by Accord Healthcare, 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.

See all 67 products in this recall →

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