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Class II · ModerateRecall completed

Isosorbide Dinitrate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLots: a) JA9535 Exp. 05/2021.
Where it was soldNationwide within the United States
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

Cross Contamination with Other Products

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 bySandoz Inc.
Brand nameISOSORBIDE DINITRATE
Generic nameISOSORBIDE DINITRATE
Active ingredient(s)ISOSORBIDE DINITRATE
Distributed by / forSandoz Inc. Princeton, NJ 08540;
NDC0781-1695-01
Show the full FDA record
Full product labelIsosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01
Recalling firmSandoz Inc
DistributionNationwide within the United States
Quantity18,832 bottles
Recall initiated2018-11-02
Report date2018-11-21
Recall completed2020-10-02
Recall numberD-0258-2019
ClassificationClass II
FDA statusTerminated
Origin on filePrinceton NJ United States

Related

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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.