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Class III · Lower riskRecall completed

Clonazepam Orally Disintegrating Tablets

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

Does this affect you?
Check your lot numberLot #: AA84106, Exp 9/2021
Where it was soldNationwide 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

Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine

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

Distributed by / forSUN PHARMACEUTICAL INDUSTRIES INC
NDC57664-783-86
Show the full FDA record
Full product labelClonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionNationwide USA
Quantity3516 bottles
Recall initiated2020-07-06
Report date2020-08-05
Recall completed2023-06-08
Recall numberD-1445-2020
ClassificationClass III
FDA statusTerminated
Origin on filePrinceton NJ United States

Related

Clonazepam 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.