FDA Announces Recall of Prazosin Hydrochloride Capsules

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

The FDA is recalling 58,896 bottles of Prazosin Hydrochloride Capsules due to detected impurities exceeding acceptable limits, affecting products distributed nationwide in the United States.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 14, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Drugs) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Appco Pharma LLC is voluntarily recalling Prazosin Hydrochloride Capsules, USP, 2mg due to a cGMP deviation involving the detection of Nitrosamine Drug Substance-Related Impurities, specifically N-nitroso-prazosin impurity C (NNP), above acceptable limits.

Which Products Are Affected

The affected products are Prazosin Hydrochloride Capsules, USP, 2mg, in 100-count bottles. NDC codes include 70377-066, 70377-067, and 70377-068. A total of 58,896 bottles are involved, with affected lots: 2404153UC (exp. 2026/MAR), 2404154UC (exp. 2026/MAR), 2502055UC (exp. 2027/JAN), 2505173UC (exp. 2027/MAY), and 2505175UC (exp. 2027/MAY). These products were distributed nationwide in the U.S.A.

What You Should Do

Consumers who have the affected products should check the lot numbers and contact the recalling firm, Appco Pharma LLC, at 262 Old New Brunswick Rd Ste N, Piscataway, NJ 08854-3888, for instructions on returns or refunds. The recall was initiated via E-Mail.

Why This Matters

This recall highlights potential safety concerns with prescription drugs due to impurities, which could affect patient health, and involves a significant number of bottles distributed across the United States.

Source

Recalled by the FDA under recall number D-0420-2026. For more information, refer to the FDA website.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
The FDA is recalling 58,896 bottles of Prazosin Hydrochloride Capsules due to detected impurities exceeding acceptable limits, affecting products distributed nationwide in the United States.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.