The FDA announced that Teva Pharmaceuticals USA will voluntarily remove more than 580,000 bottles of Prazosin due to concerns about contamination with cancer-causing chemicals.
Prazosin is an antihypertensive medication used to treat high blood pressure by relaxing blood vessels so blood can pass through them more easily. This medication may be used alone, but is often used in combination with other treatments. Prazosin may be used to treat other conditions, such as post-traumatic stress disorder or sleep disorders, under the care of a health care professional.
The FDA report classifies the hazard as Class 2 due to the presence of impurity C, N-nitrosoprazosin, which is considered carcinogenic. According to the agency, this level exceeds the acceptable intake limit established under the carcinogenic potency classification approach.
The voluntary recall involves the 2mg dose of Prazosin, which is available in units of 100 or 1000 capsules. The affected lot numbers are:
- NDC 0093-4068-01
- Lot numbers 3010398A, 3010399A, 3010400A, 3010401A, 3010353A, expiration (expiration) date: December 2025
- Lot numbers 3010439A, 3010388A, expiration date: January 2026
- Lot numbers 3010526A, 3010527A, expiration date: March 2026
- Lot No. 3010591A, July 2026; Lot #3010343A, Expiration Date: October 2025
- Lot #3010352A, Expiration Date: November 2025
- Lot numbers 3010468A, 3010469A, 3010461A, expiration date: February 2026
- Lot #3010629A, Expiration Date: September 2026
- Lot #3010653A, Expiration Date: January 2027
- Lot numbers 3010654A, 3010679A, 3010702A, expiration date: February 2027
- Lot #3010547A, Expiration Date: April 2026
- NDC 0093-4068-10
- Lot # 3010402A Expiration Date: February 2028
- Lot #3010593A, Expiration Date: July 2026
- Lot #3010610A, Expiration Date: September 2026
Pharmacists should carefully inspect prazosin stocks to ensure that affected lots are not inadvertently dispensed. Patients currently taking prazosin should not stop treatment without consulting their healthcare provider. This is because sudden discontinuation may cause side effects such as rebound hypertension. Instead, patients are encouraged to contact their pharmacist or doctor to determine if their medications are affected by the recall and to discuss alternative treatment options, if needed.
