Is Famotidine recalled?

22 FDA recalls mention Famotidine. The most recent are listed below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Famotidine.

Class I · High risk Ongoing Nov 6, 2025

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…

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

Fresenius Kabi USA, LLC NDC 63323-739-11 D-0182-2026

Class II · Moderate risk Ongoing Dec 29, 2023

Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA…

Reason Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.

Ascend Laboratories, LLC NDC 67877-626-90 D-0237-2024

Class II · Moderate risk Terminated May 1, 2023

Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ…

Reason Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton…

Glenmark Therapeutics, Inc. NDC 72657-113-20 D-0939-2023

Class II · Moderate risk Terminated Jan 20, 2021

Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown…

Reason Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.

Aurobindo Pharma USA Inc. NDC 65862-860-99 D-0290-2021

Class III · Low risk Terminated Jun 17, 2020

Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Distributed…

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

HF Acquisition Co. LLC NDC 63323-739-12 D-1392-2020

Class III · Low risk Terminated Oct 3, 2017

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

Reason Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during…

Dr. Reddy's Laboratories, Inc. NDC 55111-118-30 D-0009-2018

Class II · Moderate risk Terminated Jul 28, 2017

Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC…

Reason Failed Tablet/Capsule Specification: out of specification for tablet weight.

PD-Rx Pharmaceuticals, Inc. NDC 55289-765-30 D-1057-2017

Class II · Moderate risk Terminated Jul 24, 2017

Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC…

Reason Failed Tablet/Capsule Specification; out of specification for tablet weight

Teva Pharmaceuticals USA NDC 0172-5728-60 D-1056-2017

Class III · Low risk Terminated May 2, 2017

Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore…

Reason CGMP Deviations

Lupin Pharmaceuticals Inc. NDC 68180-150-01 D-1127-2017

Class II · Moderate risk Terminated Feb 22, 2017

Famotidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

Advanced Pharma Inc. D-0842-2017

Class II · Moderate risk Terminated Nov 10, 2015

Famotidine injection syringe a) 10 mg/1 mL b) 80 mg/8 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Reason Lack of Assurance of Sterility

Walgreens Infusion Services D-0546-2016

Class II · Moderate risk Terminated Jun 1, 2015

Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11); 10 blister packs per carton (NDC 68084-172-01)…

Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

American Health Packaging NDC 68084-172-11 D-1225-2015

Class II · Moderate risk Terminated May 28, 2015

TPN 3:1, 1750 mL Bags, Qty: 5, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes Famotidine…

Reason Lack of Assurance of Sterility: Sterility of product is not assured.

Lincare, Inc. D-1161-2015

Class II · Moderate risk Terminated May 28, 2015

TPN 3:1, 3000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes Famotidine…

Reason Lack of Assurance of Sterility: Sterility of product is not assured.

Lincare, Inc. D-1159-2015

Class II · Moderate risk Terminated May 28, 2015

TPN 3:1, 2000 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Sterile Water; Electrolytes K Acetate, Na…

Reason Lack of Assurance of Sterility: Sterility of product is not assured.

Lincare, Inc. D-1154-2015

Class II · Moderate risk Terminated May 28, 2015

TPN 3:1, 2250 mL Bags, Qty: 5, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, Intralipid 20%, Water for Inj…

Reason Lack of Assurance of Sterility: Sterility of product is not assured.

Lincare, Inc. D-1153-2015

Class II · Moderate risk Terminated May 12, 2015

Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a) freds Acid Controller, 25 Tablet Cartons…

Reason CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.

Allegiant Health D-1134-2015

Class II · Moderate risk Terminated Nov 14, 2014

Famotidine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…

Attix Pharmaceuticals D-672-2015

Class III · Low risk Terminated Jun 20, 2014

Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel…

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

Novel Laboratories, Inc. NDC 43386-500-11 D-1484-2014

Class II · Moderate risk Terminated Apr 24, 2014

Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter…

Reason Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as…

Baxter Healthcare Corp. NDC 0338-5197-41 D-0293-2015

Class II · Moderate risk Terminated Jul 2, 2013

FAMOTIDINE Tablet, 20 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 16714036104

Reason Labeling: Label Mixup; FAMOTIDINE Tablet, 20 mg may be potentially mislabeled as CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, NDC 00007337113…

Aidapak Services, LLC D-518-2014

Class III · Low risk Terminated Jun 28, 2012

Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC…

Reason Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.

Mylan Pharmaceuticals Inc. NDC 0378-3020-01 D-1703-2012

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