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Lower risk Drug recall · FDA · Published April 14, 2022

Monarch PCM Phenobarbital Elixir Recall: Alcohol Content Exceeds USP Standards

Monarch PCM recalls phenobarbital elixir bottles that exceed USP alcohol content limits. This medication is prescription-only and may not meet safety standards for use.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0878-2022DrugMonarch PCM ›
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Contact the company

Recalling firmMonarch PCM, LLC7333 Jack Newell Blvd N Ste 100 · Fort Worth, TX 76118-7151
✎ GovInfoNow plain-language explainer

Monarch PCM is recalling phenobarbital elixir bottles that exceed USP alcohol content limits. This could mean the product is unsafe for medical use as it doesn't meet the required safety standards. Read more at govinfonow.com/recall/34836-monarch-pcm-phenobarbital-elixir-recall-alcohol-content-exceeds-usp-standards.

Source Summary by GovInfoNow · govinfonow.com/recall/34836-monarch-pcm-phenobarbital-elixir-recall-alcohol-content-exceeds-usp-standards · Updated August 18, 2026 · FDA enforcement record: FDA #D-0878-2022

Cite this page

“Monarch PCM Phenobarbital Elixir Recall: Alcohol Content Exceeds USP Standards.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34836-monarch-pcm-phenobarbital-elixir-recall-alcohol-content-exceeds-usp-standards. Based on FDA recall #D-0878-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0878-2022%22&limit=1).

The FDA announced on April 14, 2022, that Monarch PCM, LLC is recalling Phenobarbital Elixir because the product exceeds USP specifications for alcohol content. The recall affects 15,730 bottles distributed in Tennessee.

How to tell if you have it

  • Brand: Monarch PCM
  • Product: Phenobarbital Elixir, USP 20 mg/5 mL
  • Size: 1 Pint (473 mL) bottles
  • NDC: 69367-172-16
  • Lot codes: 20FP1569 (Exp. 08/2022), 21FP1674 (Exp. 02/2023), 21FP1831 (Exp. 08/2023)
  • Distribution: Tennessee only

The hazard

The recall is due to the product not meeting USP or OTC Monograph standards because it exceeds the specification for alcohol content.

Context

GovInfoNow's records show Monarch PCM, LLC has three other recalls on record since September 1, 2021. Other recent recalls of similar products include Gasco Isopropyl Alcohol 70% Recall (May 29, 2026), VistaPharm Activated Charcoal Drink Recall (May 15, 2026), and another VistaPharm Activated Charcoal Drink Recall (May 15, 2026).

How to tell if you have this one

Check for phenobarbital elixir bottles labeled 20 mg/5 mL, 1 pint (473 mL), Rx Only. Look for lot numbers 20FP1569 (exp. 08/2022), 21FP1674 (exp. 02/2023), or 21FP1831 (exp. 08/2023).

  • Brand
    Monarch PCM
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the lot number and expiration date on the bottle label to confirm if it's in the recall list.

Where it went and when

Where it was distributed

Distributed in Tennessee.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “TN only” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Tennessee.

Recall timeline

FDA terminated this recall 14 months after the firm started it.

1. Firm started the recall: Apr 14, 202212. FDA classified it Class III: May 17, 202223. Published in FDA’s Enforcement Report: May 25, 202234. FDA terminated the recall: Jun 2, 2023420222023
  1. Firm started the recall
  2. FDA classified it Class III
  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.

Similar recalls

VistaPharm Activated Charcoal Drink Recall: Does Not Meet OTC Monograph Standards
VistaPharmGasco Isopropyl Alcohol 70% Recall: Subpotent Drug Risk
GascoAmerican Health Packaging Recalls Metoclopramide Tablets Due to Foreign Drug Presence
American Health PackagingTeva Recalls Metoclopramide Tablets Due to Foreign Contaminants
Teva Pharmaceuticals USA, IncPreferred Pharma Recalls Lidocaine Ointment Due to Content Issues
Preferred Pharmaceuticals, Inc.

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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-0878-2022 (April 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0878-2022 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