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Class II · ModerateActive recall

Ranitidine Syrup (Ranitidine Oral Solution

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

Does this affect you?
Check your lot numberUI1519001-A UI1519002-A UI1519003-A UI1519004-A
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

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

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 byMade in India foreign manufacturer
Distributed by / forAurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520
NDC65862-431-74
Show the full FDA record
Full product labelRanitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74
Recalling firmAuroMedics Pharma LLC
Distributionnationwide
Quantity19320 bottles
Recall initiated2019-11-06
Report date2019-12-04
Recall completed—
Recall numberD-0529-2020
ClassificationClass II
FDA statusOngoing
Origin on fileEast Windsor NJ United States

Related

Ranitidine 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.