FDA Announces Recall 580,000 Bottles of Prazosin Over Potential Carcinogenic Impurity

The FDA announced that Teva Pharmaceuticals USA will voluntarily remove over 580,000 bottles of prazosin following concerns of contamination with a cancer-causing chemical.

Prazosin is an antihypertensive used to treat hypertension through relaxation of blood vessels, allowing blood to pass more easily. The agent can be used alone but is often used alongside other treatments. Prazosin can be used to treat other conditions such as post-traumatic stress disorder or sleep disturbances under the care of a health care professional.

The FDA’s report classifies the risk as class 2 due to the presence of N-nitroso Prazosin impurity C, which is considered carcinogenic. The levels, according to the agency, are above the acceptable intake limit set by the Carcinogenic Potency Categorization Approach.

The voluntary recall includes the 2 mg dose of prazosin, which is offered in batches of 100 or 1000 capsules. Affected lot numbers include:

• NDC 0093-4068-01
  • Lot # 3010398A, 3010399A, 3010400A, 3010401A, 3010353A, Expiration (Exp) Date: 12/2025
  • Lot # 3010439A, 3010388A, Exp Date: 01/2026
  • Lot # 3010526A, 3010527A, Exp Date: 03/2026
  • Lot # 3010591A, 07/2026; Lot # 3010343A, Exp Date: 10/2025
  • Lot # 3010352A, Exp Date: 11/2025
  • Lot # 3010468A, 3010469A, 3010461A, Exp Date: 02/2026
  • Lot # 3010629A, Exp Date: 09/2026
  • Lot # 3010653A, Exp Date: 01/2027
  • Lot # 3010654A, 3010679A, 3010702A, Exp Date: 02/2027
  • Lot # 3010547A, Exp Date: 04/2026
• NDC 0093-4068-10
  • Lot # 3010402A Exp Date: 02/2028
  • Lot # 3010593A, Exp Date: 07/2026
  • Lot # 3010610A, Exp Date: 09/2026

Pharmacists should carefully examine their store of prazosin to ensure the affected lots are not mistakenly dispensed. Patients currently taking prazosin should not discontinue therapy without consulting their health care provider, as abrupt cessation may cause adverse effects such as rebound hypertension. Instead, patients are advised to contact their pharmacist or physician to confirm whether their medication is affected by the recall and to discuss alternative treatment options if necessary.

REFERENCES

1. U.S. Food and Drug Administration. Enforcement Report — Product 216512. October 7, 2025. Accessed November 3, 2025. https://www.accessdata.fda.gov/scripts/ires/?Product=216512

2. 580,000 bottles of a blood pressure drug recalled over cancer risk, FDA says. CBS News. October 31, 2025. Accessed November 3, 2025. https://www.cbsnews.com/news/blood-pressure-drug-recall-cancer-prazosin-hydrochloride-fda/

3. Prazosin (oral route). Mayo Clinic. Updated February 1, 2025. Accessed November 3, 2025. https://www.mayoclinic.org/drugs-supplements/prazosin-oral-route/description/drg-20065617

4. Associated Press. Drugmakers recall antihypertensive tainted with cancer-causing chemical. MedPage Today. October 31, 2025. Accessed November 3, 2025. https://www.medpagetoday.com/publichealthpolicy/fdageneral/118252