Recall details are shown for all drugs with the same active ingredient as the chosen drug. Please read the Product Description carefully and consult the distribution map to determine if the recall effects you.
Product Description: Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11.
Product Quantity: 25,776 containers
Identifiers: Lot #'s M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016.
Recall Reason: Failed Impurity/Degradation Specification; 12-month stability time point
Initiation Date: 06/20/2014 • Recall Number: D-1484-2014
Report Date: 09/03/2014 • Reporting Firm: Novel Laboratories, Inc.
Product Description: Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA, NDC 68180-150-01
Product Quantity: 12,888 bottles
Identifiers: Lot #: G606950, Exp 07/18
Recall Reason: CGMP Deviations
Initiation Date: 05/02/2017 • Recall Number: D-1127-2017
Report Date: 09/13/2017 • Reporting Firm: Lupin Pharmaceuticals Inc.
Product Description: Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.
Product Quantity: 19,968 bottles
Identifiers: FA2022001B, Exp 03/2025
Recall 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 indicating strength as 10 mg.
Initiation Date: 05/01/2023 • Recall Number: D-0939-2023
Report Date: 07/26/2023 • Reporting Firm: Glenmark Therapeutics, Inc.
Product Description: Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Distributed by HF Acquisition Co, LLC, Mukilteo, WA 98275, NDC 63323-739-12
Product Quantity: N/A
Identifiers: Lot #: 6122639, Exp. Date 08/2021
Recall Reason: TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Initiation Date: 06/17/2020 • Recall Number: D-1392-2020
Report Date: 07/29/2020 • Reporting Firm: HF Acquisition Co. LLC
Product Description: Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India, NDC 65862-860-99
Product Quantity: 1296 bottles
Identifiers: Lot #: P2000467, Exp 7/2022
Recall Reason: Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Initiation Date: 01/20/2021 • Recall Number: D-0290-2021
Report Date: 03/10/2021 • Reporting Firm: Aurobindo Pharma USA Inc.
Product Description: Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-626-90
Product Quantity: 3,288 bottles
Identifiers: 23140190, Exp. Date 12/31/2024
Recall Reason: Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Initiation Date: 12/29/2023 • Recall Number: D-0237-2024
Report Date: 01/24/2024 • Reporting Firm: Ascend Laboratories, LLC
Product Description: Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, b) Equate Famotidine, NDC 49035-118-30, Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, Made in India
Product Quantity: 569376 bottles
Identifiers: Lot #: a) 79C408882B, 79C408884C, 79C408886B, Exp 10/17; 79C501523B, Exp 01/18; 79C501524B, Exp 01/18; 79C502318B, Exp 3/18; b) 79C408885B, 79C408886A, Exp 10/17; 79C500967, 79C501523C, 79C501525A, 79C501525B, 79C501525C, 79C501526B, Exp 01/18; 79C502317A, Exp 3/18; 79C504087B, 79C504088A, Exp 5/18; 79C505926A, Exp 7/18.
Recall Reason: Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.
Initiation Date: 10/03/2017 • Recall Number: D-0009-2018
Report Date: 10/18/2017 • Reporting Firm: Dr. Reddy's Laboratories, Inc.
Product Description: Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41.
Product Quantity: 19,152 Containers
Identifiers: Lot #: NC082768, Exp 12/23/2014
Recall Reason: Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.
Initiation Date: 04/24/2014 • Recall Number: D-0293-2015
Report Date: 12/17/2014 • Reporting Firm: Baxter Healthcare Corp.
Product Description: Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-5728-60
Product Quantity: 28,188 bottles
Identifiers: Lot # 3429066, exp 06/2018
Recall Reason: Failed Tablet/Capsule Specification; out of specification for tablet weight
Initiation Date: 07/24/2017 • Recall Number: D-1056-2017
Report Date: 08/09/2017 • Reporting Firm: Teva Pharmaceuticals USA