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

Is NDC 0378-0616-01 recalled?

Thioridazine Hydrochloride · 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0616-01)

Yes — this exact package was recalled

1 FDA recall names the code 0378-0616-01 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
thioridazine hydrochloride
Strength
THIORIDAZINE HYDROCHLORIDE 50 mg/1
Form
Tablet, Film Coated · Oral
Labeler
Mylan Pharmaceuticals Inc.
Type
Human Prescription Drug
Product code
0378-0616

Recalls naming this package

Class II · Moderate risk

Thioridazine HCL

Labeling: Label Mixup: THIORIDAZINE HCL, Tablet, 50 mg may have potentially been mislabeled as the following drug: guanFACINE HCl, Tablet, 1 mg, NDC 00591044401, Pedigree: AD73525_13, EXP: 4/30/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-892-2014

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