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

Is NDC 0603-5168-21 recalled?

Phenobarbital · 100 TABLET in 1 BOTTLE, PLASTIC (0603-5168-21)

Yes — this exact package was recalled

1 FDA recall names the code 0603-5168-21 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
Strength
PHENOBARBITAL 97.2 mg/1
Form
Tablet · Oral
Labeler
Par Health USA, LLC
Type
Human Prescription Drug · DEA CIV
Product code
0603-5168

Recalls naming this package

Class II · Moderate risk

PHENobarbital

Labeling: Label Mixup: PHENobarbital, Tablet, 97.2 mg may have potentially been mislabeled as the following drug: EFAVIRENZ, Capsule, 200 mg, NDC 00056047492, Pedigree: AD46312_31, EXP: 5/16/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-992-2014
Class II · Moderate risk

PHENobarbital

Labeling: Label Mixup: PHENobarbital, Tablet, 97.2 mg may have potentially been mislabeled as the following drug: PHENobarbital, Tablet, 64.8 mg, NDC 00603516721, Pedigree: AD73518_7, EXP: 5/31/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-991-2014

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