FDA Recall: Over 480K bottles of Teva’s Prazosin Hydrochloride 

Teva Pharmaceuticals USA initiated a voluntary, nationwide recall of multiple lots of Prazosin Hydrochloride capsules after laboratory testing found levels of an N‑nitroso impurity (designated N‑nitroso Prazosin impurity C) above the FDA’s acceptable intake limit calculated using the Carcinogenic Potency Categorization Approach (CPCA). The agency classified the recall as Class II, indicating that use of the drug may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. 

Summary of recalled product and quantities

• Products recalled: Prazosin Hydrochloride Capsules USP, 1 mg, 2 mg, and 5 mg (prescription only), multiple NDCs and bottle sizes distributed by Teva Pharmaceuticals USA.
• Total recalled bottles (reported on FDA page):
  • 1 mg: 181,659 bottles.
  • 2 mg: 291,512 bottles.
  • 5 mg: 107,673 bottles.
• Aggregate recalled quantity: more than 480,000 bottles as reported in the FDA enforcement report.

Each recalled lot is identified on the FDA page with specific NDCs, lot numbers, and expiration dates; clinicians and pharmacists should consult the FDA list before taking action for a particular prescription or inventory item.

Scientific basis for the recall

The recall stems from detection of an N‑nitroso impurity above the CPCA acceptable intake limit. N‑nitroso compounds (NOCs) are a class of chemicals some of which are known or suspected to be carcinogenic in humans and animals. Regulators use CPCA or similar toxicological frameworks to estimate acceptable intake levels that correspond to de minimis lifetime cancer risk thresholds; when measured impurity concentrations exceed those limits, the product fails to meet current safety expectations for long‑term carcinogenic risk mitigation.

Clinical risk assessment and guidance

• Immediate patient safety: For short‑term users or patients receiving Prazosin for acute indications, the immediate risk of an acute adverse event from the impurity is low; the primary concern is a potential increased lifetime carcinogenic risk from chronic exposure if impurity levels remain above acceptable intake limits.
• Action for prescribers: Review patient medication regimens and consider alternatives when clinically appropriate, particularly for long‑term therapy. For patients already stable on therapy, weigh the risks of switching (including withdrawal, loss of control of symptoms) versus potential theoretical long‑term risk; make individualized decisions and document clinical rationale.
• Pharmacy and supply actions: Isolate and remove affected lots from distribution and patient dispensing; follow Teva or FDA instructions for return or disposition of recalled inventory as detailed in the enforcement report.

Regulatory classification and implications

A Class II recall signals that the product may cause temporary or medically reversible adverse health consequences; classification informs urgency and the recommended communication to clinical stakeholders and patients. The recall is listed in the FDA’s Enforcement Report with detailed lot‑level information allowing healthcare organizations to cross‑check their inventories and patient dispenses against specific NDCs and lot numbers.

Practical next steps for health systems

1. Inventory audit: Match stock to the FDA lot list and segregate suspected units.
2. Patient outreach: Prioritize long‑term users for clinician review; provide balanced counseling about the nature of the impurity and the rationale for any medication change.
3. Alternatives and transitions: Identify therapeutically equivalent alternatives and plan monitored transitions for patients who will switch therapy.
4. Reporting: Report any adverse events potentially related to the recalled products to the FDA MedWatch program per local protocols.

Limitations and data transparency

The FDA report summarizes the recall and reason (impurity above CPCA limit) and lists the specific lots and quantities recalled; it does not provide raw laboratory test data or a detailed toxicology dossier in the enforcement notice itself. Clinicians and organizations seeking deeper analytical detail should consult Teva communications, regulatory correspondence, or request batch analysis documentation through appropriate regulatory channels if needed.

Reference

1. U.S. Food and Drug Administration. Enforcement Report D-0104-2026 / D-0105-2026 / D-0106-2026 (Teva Prazosin Hydrochloride) — Event ID 97755. FDA; recall initiation date 10/7/2025. Available: https://www.accessdata.fda.gov/scripts/ires/?Event=97755