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

Is NDC 0078-0510-05 recalled?

Tegretol XR · 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0510-05)

Yes — this exact package was recalled

1 FDA recall names the code 0078-0510-05 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
carbamazepine
Strength
CARBAMAZEPINE 100 mg/1
Form
Tablet, Extended Release · Oral
Labeler
Novartis Pharmaceuticals Corporation
Type
Human Prescription Drug
Product code
0078-0510

Recalls naming this package

Class II ยท Moderate risk

carBAMazepine ER

Labeling: Label Mixup: carBAMazepine ER, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: ISOSORBIDE DINITRATE ER, Tablet, 40 mg, NDC 57664060088, Pedigree: AD23082_4, EXP: 5/3/2014; SIROLIMUS, Tablet, 1 mg, NDC 00008104105, Pedigree: W003329, EXP: 6/18/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-820-2014

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