Recalls / Active ingredient / Amlodipine Besylate

Amlodipine Besylate

38 FDA drug recalls involving the active ingredient “Amlodipine Besylate”.

Date	Class	Product	Firm
2025-07-21	Class II	Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Lab	Ascend Laboratories, LLC
2025-07-02	Class II	Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin	Lupin Pharmaceuticals Inc.
2023-06-27	Class III	Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals,	Lupin Pharmaceuticals Inc.
2022-02-15	Class II	Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleo	Macleods Pharma Usa Inc
2021-03-15	Class II	Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only NDC 33342-192-07 Manufactured for:	Cardinal Health Inc.
2020-02-05	Class II	Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed	Pfizer Inc.
2020-02-05	Class II	Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed	Pfizer Inc.
2019-04-01	Class III	Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceutic	Lupin Pharmaceuticals Inc.
2018-12-31	Class II	Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Phar	Aurobindo Pharma USA Inc.
2018-12-31	Class II	Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Phar	Aurobindo Pharma USA Inc.
2018-12-31	Class II	Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharm	Aurobindo Pharma USA Inc.
2018-12-31	Class II	Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Phar	Aurobindo Pharma USA Inc.
2018-12-31	Class II	Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc	Aurobindo Pharma USA Inc.
2018-12-04	Class II	Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: M	Mylan Laboratories Limited, (Nashik FDF)
2018-12-04	Class II	Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: My	Mylan Laboratories Limited, (Nashik FDF)
2018-12-04	Class II	Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: M	Mylan Laboratories Limited, (Nashik FDF)
2018-12-04	Class II	Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: M	Mylan Laboratories Limited, (Nashik FDF)
2018-11-30	Class III	Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo P	Aurobindo Pharma USA Inc.
2018-11-20	Class II	Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for:	Mylan Pharmaceuticals Inc.
2018-11-20	Class II	Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for:	Mylan Pharmaceuticals Inc.
2018-11-20	Class II	Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for	Mylan Pharmaceuticals Inc.
2018-10-03	Class III	Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, In	InvaGen Pharmaceuticals, Inc.
2017-05-05	Class III	AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd.,	Ascend Laboratories LLC
2016-02-19	Class III	Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, I	Lupin Limited
2016-02-19	Class III	Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, In	Lupin Limited
2015-08-13	Class III	Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-	Dr. Reddy's Laboratories, Inc.
2015-08-13	Class III	Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-	Dr. Reddy's Laboratories, Inc.
2015-08-13	Class III	Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by	Dr. Reddy's Laboratories, Inc.
2015-08-13	Class III	Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598	Dr. Reddy's Laboratories, Inc.
2015-08-13	Class III	Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx Only. Manufactured by	Dr. Reddy's Laboratories, Inc.
2015-08-13	Class III	Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count Bottles, Rx Only. Manufactured by	Dr. Reddy's Laboratories, Inc.
2015-08-13	Class III	Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count Bottles, Rx Only. Manufactured by	Dr. Reddy's Laboratories, Inc.
2015-05-06	Class III	Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-3	Dr. Reddy's Laboratories, Inc.
2015-05-06	Class III	Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr.	Dr. Reddy's Laboratories, Inc.
2015-05-06	Class III	Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-	Dr. Reddy's Laboratories, Inc.
2015-05-06	Class III	Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30	Dr. Reddy's Laboratories, Inc.
2014-10-01	Class III	Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd	Zydus Pharmaceuticals USA Inc
2012-04-09	Class II	Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules, Rx only, Mfd. By: Dr.	Dr. Reddy's Laboratories, Inc.