CLASS II Drug recall · Reported 26 Jan 2022 · FDA Enforcement Report

Clobazam Oral Suspension 5 mg/mL recalled by VistaPharm

VistaPharm is recalling Clobazam Oral Suspension 5 mg/mL, distributed nationwide in the US. The recall was initiated on 7 Jan 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots #: 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

Quantity recalled18,456 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0376-2022
FDA event ID: 89395
Recalling firm: VistaPharm, Largo, FL
Classification: Class II
Status: Terminated
Recall initiated: 7 Jan 2022
FDA classified: 18 Jan 2022
Reported: 26 Jan 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Seizure Medication

Timeline

7 Jan 2022	Recall initiated by company
18 Jan 2022	Classified by FDA	+11 days
26 Jan 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Stability Specifications

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04

Where it was distributed

Nationwide within the United States including Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Is Clobazam Oral Suspension 5 mg/mL recalled?

Yes. VistaPharm recalled Clobazam Oral Suspension 5 mg/mL on 7 Jan 2022. The recall is Class II and its status is Terminated. Recall number D-0376-2022.

Why was it recalled?

Failed Stability Specifications

Which lots are affected?

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

Where was it sold?

Nationwide within the United States including Puerto Rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from VistaPharm

All 36

Reported	Class	Recall	Company	Reason	Where
6 Dec 2023Drug	CLASS III	Aminocaproic Acid Oral Solution/mL recalled by VistaPharm	VistaPharm	Packaging Defects	Nationwide
15 Nov 2023Drug	CLASS III	Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL recalledMycophenolate Mofetil	VistaPharm	Other	Nationwide
25 Oct 2023Drug	CLASS I	Sucralfate Oral Suspension per PET bottle) recalled by VistaPharmSucralfate	VistaPharm	Sterility	Nationwide
20 Sep 2023Drug	CLASS II	Sucralfate Oral Suspension per, For Oral Administration Only bottle) recalledSucralfate	VistaPharm	Potency & Assay	Nationwide
2 Nov 2022Drug	CLASS II	Pyridostigmine Bromide Oral Solution, USP 60 mg/ Delivers recalledPyridostigmine Bromide	VistaPharm	Potency & Assay	Nationwide

Other Clobazam recalls

All 7

Reported	Class	Recall	Company	Reason	Where
22 Jan 2025Drug	CLASS II	Clobazam Tablets, 10 mg recalled by Amerisource Health ServicesClobazam	Amerisource Health Services	Packaging Defects	Nationwide
15 Jan 2025Drug	CLASS II	Clobazam Tablets, 10 mg recalled by Amerisource Health ServicesClobazam	Amerisource Health Services	Packaging Defects	Nationwide
28 Feb 2024Drug	CLASS II	Clobazam Tablets 10mg recalled by Micro LabsClobazam	Micro Labs	Potency & Assay	Nationwide
22 Mar 2023Drug	CLASS II	Clobazam Tablets, 20 mg, CIV recalled by Breckenridge Pharmaceutical	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
22 Mar 2023Drug	CLASS II	Clobazam Tablets, 10 mg, CIV recalled by Breckenridge Pharmaceutical	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide