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Class III · Lower riskRecall completed

Amitriptyline Hydrochloride

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

Does this affect you?
Check your lot numberLot #: a) GR3831, GS9690, Exp. 08/2019; b) GR3832, Exp. 08/2019.
Where it was soldProduct was distributed throughout 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 Product: Imipramine

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., Princeton, NJ 08540
Brand nameAMITRIPTYLINE HYDROCHLORIDE
Generic nameAMITRIPTYLINE HYDROCHLORIDE
Active ingredient(s)AMITRIPTYLINE HYDROCHLORIDE
Distributed by / forSandoz Incorporated
NDC0781-1487-01
Show the full FDA record
Full product labelAmitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540
Recalling firmSandoz Incorporated
DistributionProduct was distributed throughout the United States
Quantity38,234 bottles
Recall initiated2017-06-16
Report date2017-07-12
Recall completed2019-01-14
Recall numberD-0943-2017
ClassificationClass III
FDA statusTerminated
Origin on fileBroomfield CO United States

Related

Recent 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.