Was PEPCID Really Taken Off the Market?
Contrary to some public confusion, PEPCID (active ingredient: famotidine) has not been taken off the market [1.8.3]. The U.S. Food and Drug Administration (FDA) has evaluated famotidine and has not found it to contain the impurities that led to the recall of other medications [1.8.1]. In 2022, the FDA officially determined that certain PEPCID products were not withdrawn from sale for reasons of safety or effectiveness, reaffirming their status [1.3.1, 1.3.2]. While some specific lots or formulations of generic famotidine have faced minor recalls for issues like mislabeling or temperature control, these were not related to the widespread safety concerns that affected other drugs [1.4.1, 1.4.2].
The Root of the Confusion: The Zantac (Ranitidine) Recall
The widespread belief that PEPCID may have been recalled stems from the major market withdrawal of a different acid-reducing medication, Zantac (active ingredient: ranitidine). On April 1, 2020, the FDA requested that all manufacturers immediately withdraw all prescription and over-the-counter (OTC) ranitidine products from the market [1.9.2].
This drastic measure was the result of an ongoing investigation that discovered an impurity known as N-nitrosodimethylamine (NDMA) in ranitidine medications [1.9.1]. NDMA is classified as a probable human carcinogen, meaning it could potentially cause cancer after long-term exposure [1.9.4]. The investigation found that NDMA levels in ranitidine products could increase over time, especially when stored at temperatures higher than room temperature, leading to unacceptable levels of consumer exposure [1.9.2].
Understanding PEPCID (Famotidine) and Its Safety
PEPCID is a brand name for the drug famotidine. Like the old Zantac, it belongs to a class of drugs called histamine H2-receptor antagonists, or H2 blockers [1.6.2]. These drugs work by blocking histamine signals in the stomach, which reduces the production of stomach acid [1.5.1]. They are commonly used to treat and prevent heartburn, acid indigestion, and more serious conditions like gastroesophageal reflux disease (GERD) and stomach ulcers [1.7.2].
Crucially, the FDA's testing did not find NDMA in famotidine (PEPCID), cimetidine (Tagamet), or various proton pump inhibitors (PPIs) like esomeprazole (Nexium) and omeprazole (Prilosec) [1.9.1, 1.8.1]. This distinction is why PEPCID remained on shelves and became a recommended alternative for former ranitidine users [1.5.3]. Following the Zantac recall, demand for PEPCID and its generic versions increased significantly [1.3.5].
Comparison: PEPCID (Famotidine) vs. Old Zantac (Ranitidine)
| Feature | PEPCID (Famotidine) | Old Zantac (Ranitidine) |
|---|---|---|
| Market Status | Available over-the-counter and by prescription [1.8.3] | Withdrawn from the U.S. market in April 2020 [1.9.2] |
| Active Ingredient | Famotidine [1.7.3] | Ranitidine [1.5.1] |
| Drug Class | H2 Blocker [1.7.2] | H2 Blocker [1.5.1] |
| NDMA Contamination | FDA testing has not found NDMA [1.8.1] | Recalled due to unacceptable levels of NDMA impurity [1.9.1] |
| Safety Profile | Considered a safe alternative to ranitidine by the FDA [1.5.5] | Deemed to have potential health risks due to NDMA [1.9.1] |
It is worth noting that the manufacturer of Zantac has since released a new product called Zantac 360, which no longer uses ranitidine. The active ingredient in Zantac 360 is famotidine, the same active ingredient found in PEPCID [1.6.5, 1.7.3].
Conclusion
The answer to the question, 'Was PEPCID taken off the market?' is a clear no. PEPCID and its active ingredient, famotidine, remain safe and effective options for managing heartburn and acid reflux, according to the FDA [1.8.3]. The market confusion originated from the necessary and widespread recall of a different drug, Zantac (ranitidine), due to safety concerns over the probable carcinogen NDMA [1.9.2]. Consumers can confidently use famotidine products as directed, knowing they were not part of this major safety withdrawal. As always, consult a healthcare professional for guidance on which medication is right for you.
For more information on drug safety, you can visit the FDA's Drug Safety and Availability page.
