Zantac (Ranitidine)



Ranitidine tablets 150mg 300mg



Author: Dr. Elena Martinez, MD, FACG
Board-Certified Gastroenterologist
Last reviewed: November 18, 2025

Current Status of Zantac (Ranitidine) – Important Recall Information

April 1, 2020 – FDA requested immediate market withdrawal of all ranitidine products (Zantac and generics) due to the presence of N-nitrosodimethylamine (NDMA), a probable human carcinogen that may increase over time in the product. Most countries followed with similar withdrawals.

What Was Zantac (Ranitidine) Used For?

Before withdrawal, ranitidine was indicated for:

  • Treatment and prevention of duodenal and gastric ulcers
  • Gastroesophageal reflux disease (GERD) and erosive esophagitis
  • Zollinger-Ellison syndrome and pathological hypersecretory conditions
  • Maintenance therapy after ulcer healing
  • Heartburn, acid indigestion, and sour stomach (OTC use)

Comparison Table: Ranitidine vs Current H2-Antagonists & PPIs

DrugClassOnsetDurationNDMA IssueCurrent Availability (2025)
Ranitidine (Zantac)H2-antagonist30–60 min8–12 hYes – recalledWithdrawn in most countries
Famotidine (Pepcid)H2-antagonist1 h10–12 hNoWidely available
Cimetidine (Tagamet)H2-antagonist1 h6–8 hNoAvailable
Nizatidine (Axid)H2-antagonist30 min10–12 hVoluntary recall 2020Limited
Omeprazole (Prilosec)PPI1–2 h24 hNoWidely available

Historical Dosing Regimens (Before Withdrawal)

IndicationAdult DoseDuration
Duodenal ulcer (treatment)150 mg twice daily or 300 mg at bedtime4–8 weeks
GERD / Erosive esophagitis150 mg twice dailyUp to 12 weeks
Maintenance150 mg at bedtimeLong-term
Zollinger-Ellison150 mg three times daily (up to 6 g/day)As needed
OTC heartburn75–150 mg as needed (max 300 mg/day)≤14 days

Why Was Zantac Recalled? (NDMA Contamination)

In September 2019, independent testing found unacceptable levels of NDMA in ranitidine products. NDMA levels increased with time and temperature. FDA studies confirmed the impurity formed from the ranitidine molecule itself under certain storage conditions. The agency concluded the risk outweighed the benefit and requested complete market withdrawal in April 2020.

Current Alternatives (2025 Recommendations)

  • First-line: Famotidine (Pepcid) 20–40 mg daily
  • Second-line: Omeprazole, esomeprazole, or pantoprazole (PPIs)
  • For occasional heartburn: Calcium carbonate, magnesium hydroxide, or famotidine OTC

Official Sources

Patient Reviews (Historical – Pre-Recall)

Maria L., 47
“Zantac 150 mg at bedtime kept my reflux under control for 15 years. Switched to famotidine after the recall – works just as well.”
David R., 62
“Used Zantac 300 mg twice daily for a bleeding ulcer in 2012. Healed completely in 6 weeks. Now on pantoprazole.”
Emma T., 34
“OTC Zantac was my go-to for spicy food nights. Now using Pepcid Complete – similar relief.”

Frequently Asked Questions (FAQ)

No longer available in the USA, EU, UK, Canada, Australia, Japan, and most regulated markets due to NDMA concerns.

Yes. Multiple studies show comparable acid suppression and healing rates for ulcers and GERD.

FDA recommends disposal of any remaining ranitidine products. NDMA levels may have increased during storage.

Conclusion

Ranitidine (Zantac) was an effective and well-tolerated H2-receptor antagonist for over 35 years. Due to unacceptable NDMA contamination risk, it has been permanently withdrawn from most markets. Safe and effective alternatives (famotidine, PPIs) are widely available and preferred in current clinical practice.