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

Is NDC 65628-0080-10 recalled?

Lansoprazole · 1 KIT in 1 CONTAINER (65628-080-10) * 300 mL in 1 BOTTLE, PLASTIC * .9 g in 1 BOTTLE, PLASTIC

Yes — this exact package was recalled

1 FDA recall names the code 65628-0080-10 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
Lansoprazole
Form
Kit
Labeler
Azurity Pharmaceutcials, Inc.
Type
Bulk Ingredient
Product code
65628-0080

Recalls naming this package

Class II ยท Moderate risk

First Lansoprazole Pt 3mg/Ml

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Terminated Temperature excursion Cardinal Healthcare D-0181-2024

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