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Class II · ModerateActive recall

Acetaminophen, Ibuprofen

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

Does this affect you?
Check your lot numberLot # 17241302, exp. date Jul-26 Amazon & Walmart 17241140, exp. date Jul-26 Amazon & Walmart 17241141, exp. date Jul-26 Amazon & Walmart
Where it was soldU.S. Nationwide
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

CGMP Deviations

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 byGLENMARK THERAPEUTICS INC., USA
Brand nameACETAMINOPHEN, IBUPROFEN
Generic nameACETAMINOPHEN, IBUPROFEN
Active ingredient(s)ACETAMINOPHEN, IBUPROFEN
Distributed by / forGlenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India
NDC72657-157-74
Show the full FDA record
Full product labelAcetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India
Recalling firmGlenmark Pharmaceuticals Inc., USA
DistributionU.S. Nationwide
QuantityN/A
Recall initiated2025-03-13
Report date2025-04-16
Recall completed
Recall numberD-0347-2025
ClassificationClass II
FDA statusOngoing
Origin on fileMahwah NJ United States

Related

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.