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

Is NDC 68645-0523-54 recalled?

Sertraline Hydrochloride · 30 TABLET in 1 BOTTLE (68645-523-54)

Yes — this exact package was recalled

1 FDA recall names the code 68645-0523-54 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.

1 of these recalls is still ongoing.

Active ingredient
Sertraline Hydrochloride
Strength
SERTRALINE HYDROCHLORIDE 100 mg/1
Form
Tablet · Oral
Labeler
Legacy Pharmaceutical Packaging, LLC
Type
Human Prescription Drug
Product code
68645-0523

Recalls naming this package

Class II ยท Moderate risk

Sertraline Tablets

CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.

Ongoing cGMP deviation Legacy Pharmaceutical Packaging LLC NDC 68645-523-54 D-0205-2024

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