FDA: PEPCID RPD Famotidine Tablets Not Withdrawn for Safety

The Food and Drug Administration has determined that PEPCID RPD (famotidine) orally disintegrating tablets, 20 milligrams and 40 milligrams, were not withdrawn from sale for reasons of safety or effectiveness. The agency published the determination as a notice in the Federal Register on October 27, 2026, at 91 FR 67587. The notice states that the determination will allow FDA to approve abbreviated new drug applications (ANDAs) for famotidine orally disintegrating tablets, 20 mg and 40 mg, if all other legal and regulatory requirements are met.

At a glance

• The action is an FDA notice, document number 2026-21897, published October 27, 2026.
• The Federal Register citation is 91 FR 67587, and the notice runs one page, starting and ending on page 67587.
• The product at issue is PEPCID RPD (famotidine) orally disintegrating tablets in 20 mg and 40 mg strengths.
• The docket is FDA-2026-P-7178, described by FDA as a request that the agency determine whether the reference listed drug was voluntarily withdrawn from sale for safety or efficacy reasons.
• FDA states in the abstract that the determination will allow it to approve ANDAs for famotidine orally disintegrating tablets, 20 mg and 40 mg, if all other legal and regulatory requirements are met.

What did FDA decide about PEPCID RPD?

FDA decided that PEPCID RPD (famotidine) orally disintegrating tablets, 20 mg and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. The agency’s abstract states that the product was not withdrawn for those reasons. The notice frames the decision as a determination, an agency action published in the Federal Register, rather than a court ruling or a product recall.

The practical effect FDA describes is procedural. The determination allows FDA to approve ANDAs for famotidine orally disintegrating tablets at those two strengths. That allowance is conditional: FDA’s own wording ties it to all other legal and regulatory requirements being met.

An ANDA is an abbreviated new drug application, the FDA pathway through which a generic drug applicant relies on an already approved brand product instead of submitting full new safety and efficacy studies. The docket title describes PEPCID RPD as the reference listed drug, meaning the brand product that a generic applicant points to as the basis for its application.

What is established vs. what is alleged

There is no allegation in this record. The document is an FDA notice of determination, and it states the agency’s conclusion as the agency’s own action. Nothing in the supplied text describes a dispute, a complaint, a lawsuit, or an allegation by any party.

Established by the notice:

• FDA made a determination about PEPCID RPD (famotidine) orally disintegrating tablets, 20 mg and 40 mg.
• The determination is that the product was not withdrawn from sale for reasons of safety or effectiveness.
• The determination was published October 27, 2026, at 91 FR 67587.
• FDA’s stated consequence is that ANDAs for the same drug and strengths may be approved if all other requirements are met.

Not established, because the record does not address them: the clinical basis for the original discontinuation, the date the brand product stopped being marketed, and whether any particular ANDA has been filed or approved.

Where the matter stands procedurally

This is an agency notice, not litigation. There is no MDL, which is a multidistrict litigation, a procedure that consolidates related federal cases before one judge for pretrial proceedings, and no bellwether trial, which is a test trial chosen from a group of similar cases, connected to this document. The supplied record shows no federal case consolidation and no court proceeding at all.

The procedural home for the determination is the FDA docket. The document lists Docket No. FDA-2026-P-7178. The dockets entry carries the title “Requests that the FDA determine whether the Reference Listed Drug (RLD) PEPCID RPD™ (famotidine) ORALLY DISINTEGRATING TABLETS, 20 mg and 40 mg; New Drug Application (NDA) 020752 of MERCK RESEARCH LABORATORIES DIV MERCK CO INC. has been voluntarily withdrawn from sale for safety or efficacy reasons.”

That docket entry lists one supporting document, titled “Attachment 1 - Pepcid RPD NDA 20752 Discontinued 2002 Annual Ed.,” with document identifier FDA-2026-P-7178-0003. The docket lists zero comments. The comment window on the docket document FDA-2026-P-7178-0004 opened October 27, 2026, the publication date, and shows no closing date in the record supplied.

FDA’s abstract does not name a court and does not describe any appeal. The determination stands as a published agency action as of the information in the Federal Register entry.

Key dates

• October 27, 2026: FDA published the determination as document 2026-21897 at 91 FR 67587 in the Federal Register, and the docket comment window opened the same day.
• 2002: The docket attachment title refers to a “Discontinued 2002” annual edition for Pepcid RPD NDA 20752, which is the only reference in the record to a discontinuation year.
• November 4, 2026: The Federal Register’s page view counter for the document showed 161 views as last updated on that date.
• NDA 020752: The new drug application number FDA identifies in the docket title as belonging to MERCK RESEARCH LABORATORIES DIV MERCK CO INC., with no approval or discontinuation date given in the supplied text.

What this does not establish

The record does not state why PEPCID RPD left the market beyond what the docket title says about a request concerning voluntary withdrawal. It does not give a date on which the product was withdrawn. The “2002” reference appears only inside an attachment title, and the supplied text does not otherwise explain it.

The record does not say whether any ANDA for famotidine orally disintegrating tablets has been submitted, and it does not say that any has been approved. FDA’s abstract describes only what the determination will allow if all other legal and regulatory requirements are met.

The notice does not address the safety profile of famotidine, does not describe any adverse event, and does not recall any product. It does not create any claim, compensation, or eligibility process. Nothing in the supplied text says anything about pending litigation over famotidine, and readers looking at product recalls, litigation trackers, or FDA enforcement policy on other drug matters will find separate records on this site, such as the metoclopramide tablet recall coverage and the depo-Provera meningioma litigation overview, which are unrelated to this determination.

Frequently asked questions

What did FDA determine about PEPCID RPD (famotidine) orally disintegrating tablets?

The Food and Drug Administration determined that PEPCID RPD (famotidine) orally disintegrating tablets, 20 milligrams and 40 milligrams, were not withdrawn from sale for reasons of safety or effectiveness. FDA published that determination as a notice in the Federal Register on October 27, 2026, at 91 FR 67587. The notice states that the determination will allow FDA to approve abbreviated new drug applications for the same drug and strengths if all other legal and regulatory requirements are met.

What does the determination change for generic famotidine orally disintegrating tablets?

The Food and Drug Administration states that the determination will allow it to approve abbreviated new drug applications for famotidine orally disintegrating tablets, 20 mg and 40 mg. That allowance is expressly conditional on all other legal and regulatory requirements being met. The notice does not state that any application has been filed or approved.

Is this FDA determination a lawsuit or a settlement?

No. Document 2026-21897 is an FDA notice published in the Federal Register on October 27, 2026, at 91 FR 67587, announcing an agency determination. The record shows no court, no multidistrict litigation, no trial date, and no settlement. The associated docket is FDA-2026-P-7178.

What does the docket for FDA-2026-P-7178 contain?

The Federal Register entry for document 2026-21897 lists Docket No. FDA-2026-P-7178, whose title describes a request that FDA determine whether PEPCID RPD (famotidine) orally disintegrating tablets, 20 mg and 40 mg, New Drug Application 020752 of Merck Research Laboratories Div Merck Co Inc., was voluntarily withdrawn from sale for safety or efficacy reasons. The docket lists one supporting document, an attachment titled “Attachment 1 - Pepcid RPD NDA 20752 Discontinued 2002 Annual Ed.,” and zero comments.

Does this notice recall PEPCID RPD or say the drug is unsafe?

Neither. The notice states that PEPCID RPD (famotidine) orally disintegrating tablets, 20 mg and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. A recall is a separate agency action, and the supplied text contains no recall language. The document also does not describe any adverse event or safety finding about famotidine.

Sources

1. Federal Register (Food and Drug Administration): “Determination That PEPCID RPD (Famotidine) Orally Disintegrating Tablets, 20 Milligrams and 40 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness” (link, accessed 2026-11-05)
2. Federal Register: “All Documents” (documents API index) (link, accessed 2026-11-05)