Teva and American Health Packaging Recall Prazosin Capsules for Elevated Nitrosamine Levels

Key Clinical Summary

• Product recall: Multiple strengths (1 mg, 2 mg, and 5 mg) of Prazosin Hydrochloride Capsules, USP recalled by Teva Pharmaceuticals and American Health Packaging.
• Reason for recall: Elevated levels of N-nitroso Prazosin impurity C, a nitrosamine above acceptable carcinogenic limits.
• Scope: Nationwide Class II recall; more than 580 000 bottles and 7000 cartons impacted across multiple lots and distributors.

The US Food and Drug Administration (FDA) has announced a Class II recall involving multiple strengths of Prazosin Hydrochloride Capsules, USP (1 mg, 2 mg, and 5 mg). The affected products were distributed by Teva Pharmaceuticals USA, Inc., and by American Health Packaging (AHP) under their respective NDCs. In total, hundreds of lots were recalled, spanning more than 580 000 bottles from Teva and an additional 7000 cartons from AHP. All recalled capsules were distributed nationwide in the United States between 2025 and 2026.

The recalls, initiated voluntarily in October 2025, were classified as Class II by the FDA on October 24, 2025. Laboratory testing identified the presence of N-nitroso Prazosin impurity C—a nitrosamine compound—at levels exceeding the Carcinogenic Potency Categorization Approach (CPCA) acceptable daily intake. Nitrosamines are classified as probable human carcinogens based on animal data, and long-term exposure above acceptable limits may increase cancer risk. Although no related adverse events have been reported, the recalls were initiated out of precaution and in alignment with FDA guidance on nitrosamine impurity control.

Teva Pharmaceuticals, headquartered in Parsippany, NJ, initiated its recall on October 7, 2025, encompassing Prazosin HCl 1 mg (NDC 0093-4067), 2 mg (NDC 0093-4068), and 5 mg (NDC 0093-4069). The company notified consignees by letter, and the recall remains ongoing. Separately, American Health Packaging (an Amerisource Bergen subsidiary) recalled 1 mg, 2 mg, and 5 mg unit-dose products on October 16, 2025, distributed under NDCs 68084-996, 68084-997, and 60687-572, respectively. Both recalls are nationwide, with no press release issued and no termination date currently posted by the FDA.

Prazosin Hydrochloride is an alpha-1 adrenergic receptor antagonist indicated for the treatment of hypertension, either as monotherapy or in combination with other antihypertensive agents. It is also used off-label in managing post-traumatic stress disorder (PTSD)-related nightmares. Clinicians should verify lot numbers in inventory, discontinue dispensing affected lots, and counsel patients on alternative supply if necessary.

Reference

FDA. Enforcement Report. November 5, 2025. Accessed November 5, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm