FAMOTIDINE

Generic: FAMOTIDINE

Aurobindo Pharma LimitedManufacturer
ORALRoute
FAMOTIDINEActive Substance
2025-07-09Original Approval

FAMOTIDINE is FDA application ANDA219091, sponsored by AUROBINDO PHARMA LTD. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class III2014-06-20
Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by

Failed Impurity/Degradation Specification; 12-month stability time point

Class III2017-05-02
Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Ba

CGMP Deviations

Class II2023-05-01
Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwa

Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an ex

Class I2025-11-06
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

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Class III2020-06-17
Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Dis

TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated

Class II2021-01-20
Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-High

Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lo

Class II2023-12-29
Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd.,

Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an uno

Class III2017-10-03
Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-3

Failed impurities/degradation specifications: Famotodine has an out of specification result for an i

Class II2014-04-24
Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic,

Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the

Class II2026-08-06
Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyr

CGMP Deviations

Top Reported Reactions

1
NAUSEA
4,958 reports
2
FATIGUE
4,746 reports
3
DIARRHOEA
4,647 reports
4
OFF LABEL USE
3,951 reports
5
DYSPNOEA
3,670 reports
6
DRUG INEFFECTIVE
3,605 reports
7
CHRONIC KIDNEY DISEASE
3,524 reports
8
HEADACHE
3,353 reports
9
VOMITING
3,043 reports
10
PAIN
2,987 reports