Famotidine is an over-the-counter medicine (Histamine-2 Receptor Antagonist). The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
Class I recall (most serious) — December 3, 2025: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. Only the lots listed are affected. Check the lots
- Type
- Over the counter (OTC)
- Brand names
- acid controller, Zantac 360, equaline heartburn prevention, foster and thrive acid reducer
- Drug class
- Histamine-2 Receptor Antagonist
- Taken
- Oral
- Label
- Kenvue Brands LLC, revised February 6, 2026 · full label on DailyMed
Purpose
Acid reducer
What it is used for
relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
Active ingredient
Famotidine 10 mg
Do not use
if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers
Ask a doctor before use if you have
had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating, or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain kidney disease
Ask a doctor or pharmacist before use if you are
taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Stop use and ask a doctor if
your heartburn continues or worsens you need to take this product for more than 14 days
Warnings
Allergy alert Do not use if you are allergic to famotidine or other acid reducers Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating, or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain kidney disease Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Pregnancy or breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Famotidine in the news
We have not covered this medicine yet. Latest news
Recalls
-
Class II Ongoing
Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-5197-41.
- Lots / codes
- Lot # NC188586, Exp Date: 02/28/2027; Lot # NC188913, Exp Date: 3/9/2027.
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- Quantity
- N/A
- Recall started
- August 6, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0809-2026
-
Class I Ongoing
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
Reason: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Lots, distribution and details
- Lots / codes
- Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
- Distribution
- Nationwide within the United States as well as AK, HI, and PR.
- Quantity
- 2,199,850 vials
- Recall started
- November 6, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0182-2026
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Famotidine
We will email you if the FDA reports a recall, if its shortage status changes, or when we publish news about it — at most one email a day. No account needed.
Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 54f4086f-e443-4e7e-8c7e-94e152e1c256.