Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0515-2023·Announced 2023-04-12

Doxazosin Tablets Recalled Due to Manufacturing Process Deviations

Preferred Pharmaceuticals is recalling Doxazosin Tablets, USP, 4 mg (lot L1522V, expiration 4/30/2025) due to current Good Manufacturing Practice deviations discovered during FDA inspection of the manufacturer, Accord Healthcare. The product was 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: FDA Class II recall for manufacturing process deviations with no reported illnesses or injuries. This is a precautionary recall based on manufacturing compliance deficiency; without an identified specific hazard or patient harm reported, it meets the Moderate severity threshold.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling Doxazosin Tablets, USP, 4 mg in 100-count bottles (NDC 68788-7149-1) from lot L1522V with an expiration date of April 30, 2025. The recall was issued due to current Good Manufacturing Practice (cGMP) deviations identified at the manufacturing facility, Accord Healthcare, Inc. in Durham, North Carolina during an FDA inspection.

Doxazosin is a prescription medication used to treat high blood pressure and urinary symptoms associated with benign prostatic hyperplasia. The cGMP deviations indicate that the manufacturing process did not meet established pharmaceutical quality standards.

The affected product was distributed nationwide. Patients currently taking Doxazosin from the recalled lot should contact their healthcare provider or pharmacist for guidance regarding continued use or alternatives.

The recalled product

Product: Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7149-1
Manufacturer: Preferred Pharmaceuticals, Inc.
Category: Drug — Prescription Tablet
Hazard: manufacturing-deviation
Affected units: 4

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)

Lot: L1522V
Exp 4/30/2025.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by Preferred Pharmaceuticals, 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 17 products in this recall →

Same manufacturer · Preferred Pharmaceuticals, Inc.

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