The Recall Desk
HighFDA (Drugs)·D-0105-2026·Announced 2025-11-05

[pending] PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)

Pending LLM rewrite. Source: FDA_DRUG D-0105-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.

The recalled product

Product
PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
Brand
PRAZOSIN HYDROCHLORIDE
Manufacturer
Teva Pharmaceuticals USA, Inc
Category
Drug — Drugs

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • a) NDC 0093-4068-01: Lot # 3010398A
  • 3010399A
  • 3010400A
  • 3010401A
  • 3010353A
  • 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

UPCs (3)

  • 0300934068016
  • 0300934069013
  • 0300934067019

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · PRAZOSIN HYDROCHLORIDE

Same category