The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0806-2023·Announced 2023-06-07

FDA Recalls Granisetron HCl Injectable Drug Due to Manufacturing Compliance Failure

Akorn, Inc. recalls all lots of Granisetron HCl Injection nationwide because the manufacturer ceased operations and cannot complete required stability studies, leaving the drug's shelf-life unverified.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall due to CGMP deviations and incomplete stability testing. The manufacturer ceased operations and cannot verify the drug's shelf-life and potency. No illnesses or adverse events reported, classifying this as a precautionary quality-control recall with theoretical rather than demonstrated hazard.

Plain-English summary

Akorn, Inc. has recalled all lots of Granisetron HCl Injection, USP, 1 mg/mL, for intravenous use nationwide in the USA and Puerto Rico. The recall applies to both 1 mL and 4 mL vial presentations under all National Drug Codes (NDCs).

The FDA classified this as a Class II recall due to Current Good Manufacturing Practice (CGMP) deviations. Akorn ceased operations and can no longer conduct the ongoing stability studies required to demonstrate that the drug remains safe and effective throughout its shelf life. Without completed stability testing, the safety and potency of the product cannot be verified over time.

No illnesses or injuries have been reported. Healthcare providers should immediately stop distributing this product and quarantine existing inventory. Patients currently using this medication should consult their healthcare provider about alternative treatments. Wholesalers, hospitals, and pharmacies should verify their stock and arrange return of unused product to their distributor.

The recalled product

Product
Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only, For Intravenous Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Injectable / Antiemetic
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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