The Recall Desk
HighFDA (Drugs)·D-0103-2026·Announced 2025-11-05

Unit dose prazosin 5 mg cartons recalled over nitrosamine impurity

Amerisource Health Services is recalling 3,410 unit dose cartons of Prazosin Hydrochloride Capsules 5 mg over N-nitroso Prazosin impurity C above the acceptable intake limit.

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: Scored 3 under the risk-of-harm criterion: a named nitrosamine impurity above its acceptable intake limit is a defined safety threshold breach, with no injuries reported.

Plain-English summary

Prazosin Hydrochloride Capsules, USP, 5 mg, in 20-capsule (5x4) unit dose cartons distributed by American Health Packaging of Columbus, Ohio, are being recalled for failed impurities and degradation specifications.

The recall follows the presence of N-nitroso Prazosin impurity C above the acceptable intake limit set by the Carcinogenic Potency Categorization Approach.

The recall covers 3,410 cartons from lots 1016996, 1018336 and 1021220 (which expired 30 November 2025) and 1022421 and 1025017 (expiring 31 August 2026), carrying carton NDC 60687-572-32 and unit dose NDC 60687-572-33. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.

This is a unit dose presentation used in institutional settings. Facilities and pharmacies holding an affected lot should quarantine it and follow the firm's instructions; patients should speak to their pharmacy or prescriber rather than stopping treatment on their own.

The recalled product

Product
PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
Brand
PRAZOSIN HYDROCHLORIDE
Manufacturer
Amerisource Health Services LLC
Category
Drug — Antihypertensive
Hazard
Affected units
3,410

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 (7)

  • Lot #: 1016996
  • 1018336
  • 1021220
  • Exp. Date 11/30/2025
  • 1022421
  • 1025017
  • Exp. Date 08/31/2026.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Amerisource Health Services LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same brand · PRAZOSIN HYDROCHLORIDE

Same manufacturer · Amerisource Health Services LLC

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Same hazard · nitrosamine

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