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

Is NDC 16714-0612-04 recalled?

Sertraline Hydrochloride · 100 TABLET, FILM COATED in 1 BOTTLE (16714-612-04)

Yes — this exact package was recalled

1 FDA recall names the code 16714-0612-04 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
Sertraline Hydrochloride
Strength
SERTRALINE HYDROCHLORIDE 50 mg/1
Form
Tablet, Film Coated · Oral
Labeler
NorthStar Rx LLC
Type
Human Prescription Drug
Product code
16714-0612

Recalls naming this package

Class II ยท Moderate risk

SERTRALINE HCL Tablet

Labeling: Label Mixup; SERTRALINE HCL Tablet, 50 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 10 mg, NDC 00093081001, Pedigree: AD70585_4, EXP: 5/29/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003574, EXP: 6/24/2014; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, NDC 11523726503, Pedigree: AD46300_17, EXP: 5/15/2014; CHOLECALCIFEROL, Tablet,

Terminated Labeling / mix-up Aidapak Services, LLC D-523-2014

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