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

Is NDC 0378-3635-01 recalled?

Cetirizine Hydrochloride · 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3635-01)

Yes — this exact package was recalled

1 FDA recall names the code 0378-3635-01 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
cetirizine hydrochloride
Strength
CETIRIZINE HYDROCHLORIDE 5 mg/1
Form
Tablet, Film Coated · Oral
Labeler
Mylan Pharmaceuticals Inc.
Type
Human OTC Drug
Product code
0378-3635

Recalls naming this package

Class II · Moderate risk

Cetirizine HCL

Labeling: Label Mixup: CETIRIZINE HCL, Tablet, 5 mg may have potentially been mislabeled as the following drug: LITHIUM CARBONATE ER, Tablet, 300 mg, NDC 00054002125, Pedigree: AD39564_1, EXP: 5/13/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-906-2014

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