Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

National Drug Code

Is NDC 65162-0521-10 recalled?

Promethazine Hydrochloride · 100 TABLET in 1 BOTTLE (65162-521-10)

Yes — this exact package was recalled

1 FDA recall names the code 65162-0521-10 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
Promethazine Hydrochloride
Strength
PROMETHAZINE HYDROCHLORIDE 25 mg/1
Form
Tablet · Oral
Labeler
Amneal Pharmaceuticals LLC
Type
Human Prescription Drug
Product code
65162-0521

Recalls naming this package

Class II · Moderate risk

Promethazine HCL

Labeling:Label Mixup; PROMETHAZINE HCL, Tablet, 25 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002574, EXP: 6/3/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-707-2014

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