Appco Pharma Capsules Recalled for Nitrosamine Impurity

This alert was compiled from official government recall data published by the FDA using automated analysis. All facts are sourced directly from official records. Last verified April 14, 2026.

So here's something you need to know about if you take medication for high blood pressure or an enlarged prostate. Appco Pharma LLC is voluntarily recalling a specific batch of Prazosin Hydrochloride Capsules, USP, 1mg, sold across the U.S. This product recall in the United States affects American shoppers who use this medication, so it's important to check your medicine cabinet. Nobody wants to find out their medication is potentially unsafe.

Background on the Prazosin Recall

Prazosin Hydrochloride is a prescription drug used to treat high blood pressure and benign prostatic hyperplasia (BPH), also known as an enlarged prostate. It's typically prescribed by doctors and dispensed at pharmacies nationwide. The affected product is packaged in 100-count bottles and is intended for oral use. This recall only affects specific lot numbers; not all Prazosin Hydrochloride capsules are affected. Make sure to check your bottle for the specific identifiers mentioned below.

Appco Pharma LLC manufactures the capsules, and Biocon Pharma Inc. distributes them. If you live in a major metropolitan area or a small town, and you get your prescriptions filled at a local pharmacy or a big chain like CVS or Walgreens, this recall could affect you. The medication was distributed nationwide, meaning people from California to New York and everywhere in between might have a bottle with the affected lot number.

The Reason for the Recall

Appco Pharma LLC is recalling Prazosin Hydrochloride Capsules, USP, 1mg, due to a cGMP (current Good Manufacturing Practice) deviation. Specifically, the recall is due to the detection of a Nitrosamine Drug Substance-Related Impurity (NDSRI), N-nitroso-prazosin impurity C (NNP), above acceptable limits. These impurities can potentially increase the risk of cancer with long-term exposure based on laboratory tests, according to the FDA. That's why it's so important to check your medication.

This type of impurity is a concern because prolonged exposure above certain levels can have adverse health effects. The presence of N-nitroso-prazosin impurity C (NNP) doesn't mean the medication is immediately dangerous, but the FDA has set limits on these impurities to minimize potential risks. The agency confirmed that even though the risk to individual patients is low, they are initiating this recall for public safety.

Which Products Are Affected?

This product recall in the United States involves only Prazosin Hydrochloride Capsules, USP, 1mg, in 100-count bottles, with the following National Drug Code (NDC) and lot numbers:

• NDC 70377-066-11
• Lot 2404160C, Expiration Date: 2026/MAR
• Lot 2406253C, Expiration Date: 2026/MAY
• Lot 2407311C, Expiration Date: 2026/JUL
• Lot 2407312C, Expiration Date: 2026/JUL
• Lot 2408350C, Expiration Date: 2026/JUL
• Lot 2505172C, Expiration Date: 2027/MAY
• Lot 2506191C, Expiration Date: 2027/JUN

A total of 88,008 bottles are impacted in the United States due to this recall, according to the official recall notice. Check your prescription bottles carefully against these lot numbers, even if you purchased the medication at a major U.S. retailer.

The Severity of the Recall

The FDA has classified this as a Class II recall. This means that the use of or exposure to the recalled product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. While it’s not the most severe type of recall, it's still important to take it seriously and follow the recommended steps. Appco Pharma LLC has not announced any injuries or illnesses related to this issue.

Class II recalls are issued when a product may cause a temporary or reversible health problem, or where there is a remote chance of serious adverse health consequences. The FDA issues quite a few recalls each year across all product categories. For instance, this year alone, the agency has issued dozens of drug recalls. This recall is nationwide, affecting consumers across all U.S. states.

What You Should Do Right Now

1. Stop using the Prazosin Hydrochloride Capsules with the affected lot numbers immediately and contact your healthcare provider for advice on alternative treatment options.
2. Check the label on your bottle of Prazosin Hydrochloride Capsules, USP, 1mg, against the specific lot numbers listed above to see if yours is part of the recall.
3. Contact your pharmacy where you got your prescription filled to ask about the recalled Prazosin Hydrochloride Capsules and what alternatives are available.
4. Dispose of the recalled medication properly according to your local guidelines for disposing of prescription drugs, or return it to your pharmacy for disposal.

Frequently Asked Questions

Q: What happens if I've been taking the recalled Prazosin?

Contact your healthcare provider as soon as possible to discuss your situation and explore alternative treatment options. They can assess any potential risks and guide you on the best course of action.

Q: How do I know if my Prazosin is part of the recall?

Check the label on your bottle for the NDC number (70377-066-11) and the lot number. Compare the lot number to the list of recalled lot numbers provided above.

Q: Where was this Prazosin sold?

The recalled Prazosin Hydrochloride Capsules were sold across the U.S. through pharmacies that dispensed the medication based on prescriptions from doctors.

Q: What are nitrosamines?

Nitrosamines are organic compounds that can form during drug manufacturing and have been classified as possible human carcinogens based on laboratory tests.

Q: Is Appco Pharma LLC offering a refund?

The recall notice advises to contact your healthcare provider regarding the recalled medication but does not mention refunds directly. Contact your pharmacy for guidance on returning the product.

This recall was announced by the U.S. Food and Drug Administration (FDA). For the official notice and complete details, visit www.fda.gov.