Monarch PCM Phenobarbital Elixir Recall: Alcohol Content Exceeds USP Standards

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Recalling firmMonarch PCM, LLC7333 Jack Newell Blvd N Ste 100, N/A · Fort Worth, TX 76118-7151

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✎ GovInfoNow plain-language explainer

What happened, in plain English

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.

Why it’s dangerous

The product exceeds the USP (United States Pharmacopeia) alcohol content limits. This could affect the medication's safety and effectiveness when used as intended by healthcare providers.

Who’s affected

Prescription patients using phenobarbital elixir from Monarch PCM. Those with specific lot numbers and expiration dates listed in the recall notice are most at risk.

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

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

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The product does not meet USP alcohol content standards, which could affect safety and effectiveness. Consult your healthcare provider for guidance.

What should I do if I have this product?

Check the lot number and expiration date. If it matches the recalled lots, contact your healthcare provider for advice.

How can I get a replacement?

The recall notice does not specify a replacement process. Contact your healthcare provider for assistance.

Take action

Contact Monarch PCM

We’ve drafted a message you can send Monarch PCM to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0878-2022 — Monarch PCM Monarch PCM

Hello,

I own a Monarch PCM that is covered by recall D-0878-2022 from Monarch PCM.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Monarch PCM, LLC recalls Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals,

Lower-risk recall