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

Is NDC 59212-0425-10 recalled?

Donnatal · 100 TABLET in 1 BOTTLE, PLASTIC (59212-425-10)

Yes — this exact package was recalled

1 FDA recall names the code 59212-0425-10 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.

Active ingredient
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Strength
PHENOBARBITAL 16.2 mg/1; HYOSCYAMINE SULFATE .1037 mg/1…
Form
Tablet · Oral
Labeler
Advanz Pharma (US) Corp.
Type
Human Prescription Drug · DEA CIV
Product code
59212-0425

Recalls naming this package

Class III · Low risk

Donnatal

Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.

Terminated Labeling / mix-up Rx PAK NDC 59212-425-10 D-0053-2016

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.