The Recall Desk
ModerateFDA (Drugs)·D-0386-2023·Announced 2023-03-08

Prescription Doxazosin Tablets Recalled Due to Manufacturing Practice Deviations

Accord Healthcare is recalling 44,068 bottles of Doxazosin 1 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations found 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 based on manufacturing practice compliance violations rather than a demonstrated health hazard. No illnesses, injuries, or hospitalizations are reported. The recall addresses a theoretical quality risk, consistent with voluntary precautionary recalls classified as Moderate.

Plain-English summary

Accord Healthcare, Inc. is recalling 44,068 bottles of Doxazosin 1 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. The product, manufactured by Intas Pharmaceuticals Limited, was distributed throughout the United States, Puerto Rico, and Canada.

The affected batches include R2200402, R2200642, R2200643, R2201300, and R2200403, with expiration dates between May 31, 2024, and August 31, 2024. The tablets are supplied in 100-count and 1,000-count bottles (NDC 16729-211-01 and NDC 16729-211-17).

CGMP deviations indicate manufacturing quality defects. Patients currently using this medication should consult their pharmacist or healthcare provider with any questions before discontinuing the medication.

The recalled product

Product
DOXAZOSIN (DOXAZOSIN)
Brand
DOXAZOSIN
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Prescription Oral Tablet
Hazard
Affected units
44,068

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 (6)

  • Batches: a) R2200402
  • Exp. Date 5/31/2024
  • R2200642
  • R2200643 Exp. Date 8/31/2024
  • R2201300 Exp. Date 8/31/2024
  • b) R2200403

UPCs (2)

  • 316729211017
  • 316729211178

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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