The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0809-2023·Announced 2023-06-07

HydrALAZINE Injection Recalled Due to Manufacturing Deviations and Unverified Stability

Akorn, Inc. recalled all lots of HydrALAZINE HCl Injection nationwide because the manufacturer ceased operations and could no longer conduct required stability studies.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is a risk-of-harm injectable product with no reported illnesses or injuries. The hazard is theoretical—inability to verify product stability—rather than a confirmed defect. Per the rubric, theoretical hazards without reported illness do not exceed Score 3, but the injectable drug category and manufacturing practice deviations place it at High rather than Moderate.

Plain-English summary

Akorn, Inc. recalled all lots of HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL single-dose vials due to current good manufacturing practice (CGMP) deviations. The manufacturer went out of business and could no longer continue the stability studies required to verify the product's safety and effectiveness.

The affected product was distributed nationwide in the USA and Puerto Rico. This is a prescription injectable medication administered intravenously or intramuscularly for blood pressure management.

Patients who have received this medication should consult their healthcare provider to discuss their specific situation and explore alternative treatment options. Healthcare providers should review patient records to identify individuals who may have received affected doses and discuss appropriate follow-up care.

The recalled product

Product
HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Injectable / Injection
Hazard

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 (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. 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 86 products in this recall →

Related recalls

Same manufacturer · Akorn, Inc.

See all →

Same hazard · cgmp deviation

See all →

Similar recalls