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Class II · ModerateRecall completed

Methylphenidate Hydrochloride

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

Does this affect you?
Check your lot numberLot AC74459, Exp 07/31/2024
Where it was soldNationwide
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

Presence of Foreign Substance: Metal embedded in a tablet.

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 byOhm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512
Brand nameMETHYLPHENIDATE HYDROCHLORIDE
Generic nameMETHYLPHENIDATE HYDROCHLORIDE
Active ingredient(s)METHYLPHENIDATE HYDROCHLORIDE
Distributed by / forSun Pharmaceutical Industries Inc., Cranbury, NJ 08512
NDC57664-230-88
Show the full FDA record
Full product labelMethylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 57664-230-88.
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionNationwide
Quantity7313 bottles
Recall initiated2023-07-13
Report date2023-08-02
Recall completed2024-02-12
Recall numberD-0940-2023
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.