Nearly 581,000 bottles of a blood pressure medication have been pulled from distribution after laboratory analysis detected potentially carcinogenic substances exceeding federal safety thresholds.
Teva Pharmaceuticals initiated a voluntary withdrawal of prazosin hydrochloride capsules on October 7. Federal regulators classified the recall as Class II risk on October 24, a designation indicating that product use “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The withdrawal affects three dosage formulations of the medication distributed across the United States. Physicians primarily prescribe the drug for hypertension and prostate enlargement, though some practitioners recommend it off-label for post-traumatic stress disorder symptom management.
Laboratory testing identified elevated concentrations of N-nitroso prazosin impurity in the recalled capsules, according to federal regulatory documentation.
The recall encompasses:
1 mg capsules: 181,659 bottles (NDC 0093-4067-01 and 0093-4067-10) with lot numbers 3010544A and 3010545A, expiring in October 2025.
2 mg capsules: 291,512 bottles (NDC 0093-4068-01 and 0093-4068-10) across multiple lot numbers with expiration dates ranging from October 2025 through July 2026.
5 mg capsules: 107,673 bottles (NDC 0093-4069-01, 0093-4069-52, and 0093-4069-05) across multiple lot numbers with expiration dates extending into 2026.
Patients currently taking the recalled medication should contact their healthcare providers immediately, as abruptly stopping blood pressure treatment can create dangerous cardiovascular complications.
Teva Pharmaceuticals has sent notification letters to customers and the recall process continues. Patients with questions about whether their prescriptions are affected should consult pharmacists or physicians to verify their medication’s status and explore alternative treatments.
The 581,000 bottle recall magnitude affecting three dosage strengths demonstrates widespread contamination throughout Teva’s prazosin production, with the scale suggesting systematic manufacturing problems rather than isolated batch contamination that quality control should have detected.
The October 7 voluntary recall announcement followed by October 24 FDA Class II classification indicates nearly three weeks elapsed between company acknowledgment and federal risk categorization, with the delay potentially leaving patients consuming contaminated medication while bureaucratic classification processes completed.
The Class II designation characterizing health consequences as “temporary or medically reversible” or having “remote” probability of serious harm attempts to minimize alarm, though the cancer-causing chemical presence creates legitimate long-term concerns that “reversible” language doesn’t fully capture.
The three dosage strengths of 1mg, 2mg, and 5mg covering the medication’s typical prescribing range means virtually all prazosin patients potentially received contaminated product, with the comprehensive dosage impact suggesting the impurity originated in raw materials or early manufacturing stages affecting all subsequent production.
The nationwide distribution creating coast-to-coast patient exposure, with the geographic breadth meaning Seattle-area pharmacies likely dispensed contaminated bottles alongside stores in every other state, requiring local healthcare providers to contact patients and manage medication transitions.
Prazosin’s dual use for hypertension and prostate conditions means the recall affects distinct patient populations, with older men taking the drug for benign prostatic hyperplasia potentially facing different risk-benefit calculations than younger hypertension patients given their varying life expectancies and cancer risk profiles.
The off-label PTSD prescription practice means some veterans and trauma survivors take prazosin for nightmares and sleep disturbances, with the recall potentially disrupting treatments for vulnerable populations already managing significant mental health challenges beyond the medication’s primary cardiovascular indications.
The N-nitroso prazosin impurity representing a nitrosamine compound class known for carcinogenic properties, with these chemicals forming during manufacturing through reactions between amines and nitrosating agents under specific temperature and pH conditions that proper process controls should prevent.
The FDA’s detection of “elevated levels” above acceptable limits indicates that some nitrosamine presence may be tolerable, with regulatory agencies establishing threshold concentrations below which cancer risks are considered negligible, though the specific concentration levels in recalled prazosin remain undisclosed.
The lot numbers spanning multiple production batches with expiration dates from October 2025 through 2026 suggests contamination persisted for extended manufacturing periods, with the timeline indicating quality control failures missed the impurity across months of production rather than catching problems quickly.
The 1mg dosage with 181,659 recalled bottles representing the smallest quantity suggests either lower prescribing frequency for that strength or more recent production start, with the distribution across strengths potentially providing clues about when contamination began.
The 2mg dosage accounting for 291,512 bottles or roughly half the total recall volume indicates this strength represents either the most commonly prescribed formulation or longest production run, with the concentration potentially reflecting standard prescribing practices favoring intermediate dosing.
The 5mg capsules totaling 107,673 bottles representing the smallest recalled quantity despite being the highest strength suggests either less frequent prescribing of maximum doses or more recent production introduction, with the pattern potentially reflecting physician prescribing preferences.
The NDC (National Drug Code) numbers enabling precise product identification allowing pharmacists to verify whether specific bottles match recalled lot numbers, with the standardized coding system preventing confusion about which products require return versus continued dispensing.
The patient guidance emphasizing “consult healthcare provider as soon as possible” while warning against abruptly stopping medication creates tension between contamination concerns and cardiovascular risks from untreated hypertension, with the dual warnings potentially leaving patients uncertain about the safest course.
The sudden discontinuation dangers from blood pressure medications including rebound hypertension where blood pressure spikes dangerously after stopping treatment, with the phenomenon potentially causing strokes, heart attacks, or other acute cardiovascular events more immediately threatening than long-term cancer risks from contaminated medication.
The company notification letters to customers representing direct-to-pharmacy communications enabling retail pharmacies to identify affected inventory and contact patients, though the notification process depends on pharmacies maintaining accurate patient contact information and patients responding to outreach attempts.
The ongoing recall status indicating Teva continues managing product returns and patient notifications, with the extended timeline reflecting pharmaceutical recalls’ complexity requiring coordination across manufacturers, distributors, pharmacies, and prescribers to ensure complete contaminated product removal.
Seattle-area implications including local pharmacies dispensing recalled prazosin to Puget Sound region patients requiring healthcare providers across King, Snohomish, Pierce, and surrounding counties to identify affected individuals and transition them to alternative hypertension or prostate treatments.
The alternative treatment options including other alpha-blockers like doxazosin or terazosin for prostate conditions and various antihypertensive drug classes for blood pressure, with the availability of substitutes enabling relatively smooth transitions though individual responses to different medications vary.
The recall’s addition to growing list of pharmaceutical contamination incidents where nitrosamine impurities have triggered withdrawals of ranitidine, valsartan, and other medications in recent years, with the pattern suggesting widespread manufacturing quality control problems requiring industry-wide reforms beyond individual company recalls.
