The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0388-2023·Announced 2023-03-08

Doxazosin tablets recalled due to manufacturing quality control deviations

Accord Healthcare is recalling 75,190 bottles of Doxazosin 4 mg tablets due to manufacturing quality control deviations discovered during an FDA inspection. No illnesses have been reported.

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 with no reported illnesses or injuries. The manufacturing quality control deviations identified during FDA inspection represent a potential risk of harm where injury has not yet been reported.

Plain-English summary

Accord Healthcare, Inc. is recalling Doxazosin tablets USP, 4 mg, due to manufacturing quality control deviations identified during a U.S. Food and Drug Administration inspection.

The recall affects 75,190 bottles distributed in the United States, including Puerto Rico and Canada. Affected batches are: R2200352 (expires 5/31/2024), R2200356 (expires 8/31/2024), R2200357 (expires 8/31/2024), R2200633 (expires 4/30/2025), R2200634 (expires 4/30/2025), R2200677 (expires 8/31/2024), R2200572 (expires 4/30/2025), R2200571 (expires 4/30/2025), and R2200646 (expires 4/30/2025). The affected product is sold under NDC numbers 16729-213-01 (100-count bottles) and 16729-213-17 (1,000-count bottles).

Patients currently taking this medication should not stop their medication without consulting their healthcare provider or pharmacist. No illnesses or adverse events associated with this recall have been reported.

The recalled product

Product
DOXAZOSIN (DOXAZOSIN)
Brand
DOXAZOSIN
Manufacturer
Accord Healthcare, Inc.
Category
Drug
Hazard
Affected units
75,190

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 (12)

  • Batches: a) R2200352
  • Exp. Date 5/31/2024
  • R2200356
  • Exp. Date 8/31/2024
  • R2200357
  • R2200633
  • Exp. Date 4/30/2025
  • R2200634
  • b) R2200677
  • R2200572
  • R2200571
  • R2200646

UPCs (2)

  • 316729213011
  • 316729213172

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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