The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0376-2022·Announced 2022-01-26

Clobazam Oral Suspension Recalled for Failed Stability Specifications

VistaPharm is recalling Clobazam Oral Suspension 2.5 mg/mL due to failed stability specifications. The recall affects 18,456 bottles distributed nationwide.

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: This is an FDA Class II recall. The source text does not report any illnesses, injuries, or deaths. The hazard is a manufacturing/stability issue without documented patient harm reported, which aligns with a Moderate rating for a Class II pharmaceutical recall.

Plain-English summary

VistaPharm, Inc. is recalling Clobazam Oral Suspension 2.5 mg/mL in 120 mL bottles due to failed stability specifications. The recalled product is an Rx-only medication manufactured by VistaPharm, Inc. in Largo, Florida (NDC 66689-058-04).

A total of 18,456 bottles have been distributed nationwide within the United States, including Puerto Rico. The recall affects multiple lot numbers with varying expiration dates: Lots 678900, 682000, 682400 (Exp. 5/31/2022); 680600, 680800, 681000 (Exp. 5/30/2022); 683200, 685200 (Exp. 6/30/2022); 728900, 733100 (Exp. 12/31/2022); 738600 (Exp. 1/31/2023); 740600, 741600 (Exp. 2/28/2023); 749800, 750900, 752400 (Exp. 3/31/2023); and 775700 (Exp. 6/30/2023).

Patients and healthcare providers should stop using affected bottles and contact their pharmacy or healthcare provider for guidance on obtaining replacement medication or alternative treatments.

The recalled product

Product
Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04
Manufacturer
VistaPharm, Inc.
Category
Drug — Anticonvulsant
Hazard
Affected units
18,456

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 (18)

  • Lots #: 678900
  • 682000
  • 682400
  • Exp. 5/31/2022
  • 680600
  • 680800
  • 681000 Exp. 5/30/2022
  • 683200
  • 685200 Exp. 6/30/2022
  • 728900
  • 733100 Exp. Date 12/31/2022
  • 738600 Exp. 1/31/2023
  • 740600
  • 741600 Exp. 2/28/2023
  • 749800
  • 750900
  • 752400 Exp. 3/31/2023
  • 775700 Exp. 6/30/2023

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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