Medications & Supplements/Prescription Drugs

Phenobarbital Elixir Recalled for Excessive Alcohol Content

Agency Publication Date: May 17, 2022

Summary

Monarch PCM, LLC is recalling 15,730 bottles of Phenobarbital Elixir (20 mg/5 mL) because the product contains alcohol levels that exceed required USP specifications. This prescription medication, sold under the Westminster Pharmaceuticals brand, is used to treat seizures and for sedation but was found to have incorrect alcohol concentrations during testing. No injuries or adverse events have been reported to date, but consumers should consult their healthcare provider regarding any concerns.

Risk

The higher-than-specified alcohol content may cause unexpected side effects or drug interactions, particularly in patients sensitive to alcohol or those taking other central nervous system depressants. Excessive alcohol in a sedative medication can increase the risk of drowsiness, respiratory depression, or altered mental status.

What You Should Do

This recall affects 1-pint (473 mL) bottles of Phenobarbital Elixir, USP 20 mg/5 mL, distributed by Westminster Pharmaceuticals, LLC (NDC 69367-172-16).
Check your bottle for lot numbers 20FP1569 (Exp. 08/2022), 21FP1674 (Exp. 02/2023), and 21FP1831 (Exp. 08/2023).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Phenobarbital Elixir, USP 20 mg/5 mL (1 Pint/473 mL)by Westminster Pharmaceuticals, LLC

Variants: 20 mg/5 mL, 1 Pint (473 mL) bottle

Lot Numbers:

20FP1569 (Exp 08/2022)

21FP1674 (Exp 02/2023)

21FP1831 (Exp 08/2023)

NDC:

69367-172-16

Recall #: D-0878-2022. Quantity affected: 15,730 bottles.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90062

Status: Resolved

Manufacturer: Monarch PCM, LLC

Sold By: Westminster Pharmaceuticals, LLC

Manufactured In: United States

Units Affected: 15,730 bottles

Distributed To: Tennessee

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects 1-pint (473 mL) bottles of Phenobarbital Elixir, USP 20 mg/5 mL, distributed by Westminster Pharmaceuticals, LLC (NDC 69367-172-16).

Check your bottle for lot numbers 20FP1569 (Exp. 08/2022), 21FP1674 (Exp. 02/2023), and 21FP1831 (Exp. 08/2023).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for additional information.