Prazosin Hydrochloride, Capsules, USP, 5 mg

Amerisource Health Services LLC has recalled Prazosin Hydrochloride, Capsules, USP, 5 mg, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on November 5, 2025 and was initiated on October 16, 2025. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Prazosin Hydrochloride, Capsules, USP, 5 mg, with approximately 3,410 cartons affected. The company behind the recall is Amerisource Health Services LLC, based in Columbus, OH. The FDA describes the product as: “Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 60687-572-33”

Why was Prazosin Hydrochloride, Capsules, USP, 5 mg recalled?

According to the FDA, the stated reason for the recall is: “Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit.” In plain terms, this recall relates to a chemical impurity.

This recall involves an unwanted chemical detected in the medicine — often a nitrosamine impurity, which regulators limit because long-term exposure above set levels may increase health risks. Regulators recall affected batches as a precaution. Health authorities generally advise talking to a doctor or pharmacist before stopping a prescribed medicine.

What should you do?

If you think you may have bought Prazosin Hydrochloride, Capsules, USP, 5 mg, compare it against the product description and identifying codes (Lot #: 1016996, 1018336, 1021220, Exp. Date 11/30/2025; 1022421, 1025017, Exp. Date 08/31/2026.) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Amerisource Health Services LLC or your local health authority.

About this recall

This recall was distributed in OH. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.