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Class III · Lower riskRecall completed

Metformin Hydrochloride

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #JKU4639A, Exp 10/2022
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Moisture Limits: Out of specification for water content

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySun Pharmaceutical Industries Ltd., Halol-Baroda HIghway, Halol-389 350 Gujarat, India foreign manufacturer
Brand nameMETFORMIN HYDROCHLORIDE
Generic nameMETFORMIN HYDROCHLORIDE
Active ingredient(s)METFORMIN HYDROCHLORIDE
Distributed by / forSun Pharmaceutical Industries, Inc., Cranbury, NJ 08512;
NDC62756-142-02
Show the full FDA record
Full product labelMetformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda HIghway, Halol-389 350 Gujarat, India, NDC 62756-142-02.
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionNationwide in the USA
Quantity2520 bottles
Recall initiated2021-03-25
Report date2021-04-14
Recall completed2022-04-14
Recall numberD-0325-2021
ClassificationClass III
FDA statusTerminated
Origin on filePrinceton NJ United States

Related

Metformin recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.