The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0811-2023·Announced 2023-06-07

Akorn Hydromorphone Hydrochloride Injection Recalled Due to CGMP Deviations

Akorn, Inc. is recalling all lots of Hydromorphone Hydrochloride Injection due to CGMP deviations. The firm went out of business and could not complete required stability testing.

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: FDA Class II drug recall with CGMP deviations and incomplete stability studies. No adverse events or injuries are reported. Per the rubric, theoretical hazards without reported illness or injury score at most 3 (High).

Plain-English summary

Akorn, Inc. is recalling all lots of Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL). The product is supplied in 1 mL ampules, 5 mL ampules, and 50 mL vials. This is a prescription injectable opioid pain medication.

The recall was initiated due to CGMP (Current Good Manufacturing Practice) deviations. The manufacturer went out of business and could no longer continue the required stability studies for the product.

The recalled product was distributed nationwide in the USA and Puerto Rico. All lots are included in this recall.

The recalled product

Product
Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Prescription Injectable Opioid
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 →

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