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

Is NDC 69315-0904 recalled?

Lorazepam

This product was recalled — in other package sizes

No FDA recall names your exact package code, but 2 recalls cover the same product (69315-0904) in a different bottle or carton size. Worth checking with your pharmacist.

1 of these recalls is still ongoing.

Active ingredient
Lorazepam
Strength
LORAZEPAM .5 mg/1
Form
Tablet · Oral
Labeler
Leading Pharma, LLC
Type
Human Prescription Drug · DEA CIV
Product code
69315-0904

Recalls of this product

Class II · Moderate risk

Lorazepam Tablets

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Ongoing Impurity / degradation The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories D-0226-2025
Class II · Moderate risk

Lorazepam Tablets

Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam

Terminated Labeling / mix-up Leading Pharma, LLC NDC 69315-904-05 D-0085-2018

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