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Class II · ModerateRecall completed

Clonazepam Orally Disintegrating Tablets

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

Does this affect you?
Check your lot numberLot #: MHC1430A, Exp. Date 09/2023
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

Failed Tablet/Capsule Specification; oversized tablet found in a bottle

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
NDC57664-783-68
Show the full FDA record
Full product labelClonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, NDC 57664-783-68, packaged in bottles.
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
Distributionnationwide within the United States
Quantity4608 bottles
Recall initiated2022-06-03
Report date2022-06-29
Recall completed2023-08-18
Recall numberD-1155-2022
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.