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

Is NDC 10631-0206-01 recalled?

Riomet · 118 mL in 1 BOTTLE (10631-206-01)

Yes — this exact package was recalled

1 FDA recall names the code 10631-0206-01 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/5mL
Form
Solution · Oral
Labeler
Sun Pharmaceutical Industries, Inc.
Type
Human Prescription Drug
Product code
10631-0206

Recalls naming this package

Class III · Low risk

Riomet (metformin hydrochloride oral solution)

Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.

Terminated Labeling / mix-up Sun Pharmaceutical Industries, Inc. NDC 10631-206-02 D-0818-2018

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