Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 69367-0172-16 recalled?

Phenobarbital Elixir

Yes — this exact package was recalled

1 FDA recall names the code 69367-0172-16 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

This code is not in the current FDA NDC directory — usual for a product that has since been discontinued or repackaged. The details below come from the recall notices themselves.

Recalls naming this package

Class III ยท Low risk

Phenobarbital Elixir

Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content

Terminated Unapproved drug Monarch PCM, LLC NDC 69367-172-16 D-0878-2022

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler