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

Is NDC 72189-0064-90 recalled?

Metformin Hydrochloride Extended Release · 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-064-90)

Yes — this exact package was recalled

1 FDA recall names the code 72189-0064-90 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
metformin hydrochloride
Strength
METFORMIN HYDROCHLORIDE 500 mg/1
Form
Tablet, Extended Release · Oral
Labeler
direct rx
Type
Human Prescription Drug
Product code
72189-0064

Recalls naming this package

Class II ยท Moderate risk

Metformin HCL E/R 500 mg

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Terminated Nitrosamine impurity Direct Rx NDC 72189-064-90 D-0058-2021

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