Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Phenobarbital Elixir Recalled by Monarch PCM, LLC Due to Does Not Meet USP or OTC Monograph: Product...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Monarch PCM, LLC directly.
Affected Products
Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16
Quantity: 15,730 bottles
Why Was This Recalled?
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Where Was This Sold?
This product was distributed to 1 state: TN
About Monarch PCM, LLC
Monarch PCM, LLC has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report