The Recall Desk
HighFDA (Drugs)·D-0101-2026·Announced 2025-11-05

[pending] PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)

Pending LLM rewrite. Source: FDA_DRUG D-0101-2026.

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

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

The recalled product

Product
PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
Brand
PRAZOSIN HYDROCHLORIDE
Manufacturer
Amerisource Health Services LLC

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 (3)

  • Lot #: 1023526
  • 1023555
  • Expiry: 07/31/2026

Distribution

Distributed nationwide across the United States.

Same brand · PRAZOSIN HYDROCHLORIDE