Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

National Drug Code

Is NDC 53746-0178 recalled?

metFORMIN HCL ER USP 500 mg

This product was recalled — in other package sizes

No FDA recall names your exact package code, but 7 recalls cover the same product (53746-0178) in a different bottle or carton size. Worth checking with your pharmacist.

5 of these recalls are still ongoing.

This code is not in the current FDA NDC directory — usual for a product that has since been discontinued or repackaged. The details below come from the recall notices themselves.

Recalls of this product

Class II · Moderate risk

metFORMIN HCL ER USP 500 mg

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Terminated Nitrosamine impurity PD-Rx Pharmaceuticals, Inc. D-1307-2020
Class I · High risk

metFORMIN ER Tablets

Labeling: Label Mix up; product labeled did not indicated Extended Release

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 53746-178-01 D-1448-2014

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