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Lower risk Drug recall · FDA · Published January 7, 2022

VistaPharm Clobazam Oral Suspension 2.5 mg/mL Recall: Failed Stability Specifications

VistaPharm recalls certain Clobazam Oral Suspension 2.5 mg/mL bottles due to failed stability specifications. These products may not remain safe or effective over time.

🇺🇸 FDA recall #D-0376-2022DrugVistaPharm ›
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Recalling firmVistaPharm, Inc.7265 Ulmerton Rd · Largo, FL 33771-4809
✎ GovInfoNow plain-language explainer

What happened, in plain English

VistaPharm is recalling specific batches of Clobazam Oral Suspension 2.5 mg/mL (120 mL) bottles that failed stability tests. This means the medication could become unsafe or ineffective if stored for longer than the expiration date. Read more at govinfonow.com/recall/35396-vistapharm-clobazam-oral-suspension-2-5-mg-ml-recall-failed.

Source Summary by GovInfoNow · govinfonow.com/recall/35396-vistapharm-clobazam-oral-suspension-2-5-mg-ml-recall-failed · Updated August 18, 2026 · FDA enforcement record: FDA #D-0376-2022

Cite this page

“VistaPharm Clobazam Oral Suspension 2.5 mg/mL Recall: Failed Stability Specifications.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35396-vistapharm-clobazam-oral-suspension-2-5-mg-ml-recall-failed. Based on FDA recall #D-0376-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0376-2022%22&limit=1).

Why it’s dangerous

The medication failed stability specifications, meaning it may not remain safe or effective over time. This could lead to the product becoming unstable or ineffective if stored beyond the expiration date.

Who’s affected

People prescribed Clobazam by a doctor who received these specific batch numbers of the 120 mL bottles. Those with the medication nearing or past expiration dates are most at risk.

How to tell if you have this one

Check the product label for the batch numbers listed: 678900, 682000, 682400 (expiring 5/31/2022), 680600, 680800, 681000 (expiring 5/30/2022), 683200, 685200 (expiring 6/30/2022), and others listed in the recall notice.

  • Brand
    VistaPharm
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the batch numbers listed in the recall notice to confirm if your product is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “Nationwide within the United States including Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.9 years after the firm started it.

1. Firm started the recall: Jan 7, 202212. FDA classified it Class II: Jan 18, 202223. Published in FDA’s Enforcement Report: Jan 26, 202234. FDA terminated the recall: Dec 13, 2024420222024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0376-2022 (January 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0376-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA