Three dosage levels are impacted after a chemical byproduct was found to exceed acceptable limits.
National data suggest that in 2023, more than 660,000 Americans died due to high blood pressure as a primary or contributing cause. It’s also reported 48% of Americans currently have, or are treating, high blood pressure.
Those patients should know of a new recall on blood pressure medication by a New Jersey-based pharmaceutical company. On March 27, a recall was initiated on a total of 175,061 bottles of one-milligram, two-milligram, and five-milligram dosages of Prazosin Hydrochloride Capsules manufactured by Appco Pharma LLC in Piscataway, NJ, for Biocon Pharma, Inc. in Iselin, NJ.
A U.S. Food and Drug Administration (FDA) report released on April 1 reveals that on March 31, the FDA determined this to be a Class II recall, which they define as “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.”
The agency cites the reason for the recall to be “cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.”
Nitrosamine levels have come under tighter regulation in recent years as the chemical byproduct occurring in some blood pressure medications. Nitrosamines have been found to be what one 2024 paper from the U.S. Department of Health and Human Services described as “probable or possible human carcinogens” that “in certain drug products has made clear the need for a risk assessment strategy.” Carcinogens are defined by the Cleveland Clinic as “substances that may increase your risk of cancer.”
Speak immediately with your doctor or pharmacist before stopping your prazosin hydrochloride medication, if it bears these identifying recalled details:
Prazosin Hydrochloride Capsules, 1mg (NDC 70377-066-11)
- Lot codes and expiration dates:
- 2404160C, exp. March 2026
- 2406253C, exp. May 2026
- 2407311C, exp. July 2026
- 2407312C, exp. July 2026
- 2408350C, exp. July 2026
- 2505172C, exp. May 2027
- 2506191C, exp. June 2027
Prazosin Hydrochloride Capsules, 2mg (NDC 70377-067-11)
- Lot codes and expiration dates:
- 2404153UC, exp. March 2026
- 2404154UC, exp. March 2026
- 2502055UC, exp. January 2027
- 2505173UC, exp. May 2027
- 2505175UC, exp. May 2027
Prazosin Hydrochloride Capsules, 5mg (NDC 70377-068-11)
- Lot codes and expiration dates:
- 2406255UC, exp. May 2026
- 2406256UC, exp. July 2026
- 2407313UC, exp. July 2026
- 2408351UC, exp. July 2026
- 2408352UC, exp. July 2026
- 2509311UC, exp. September 2027
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