Skip to content

Blood Pressure Medication Recalls

Recalls of ARBs, ACE inhibitors, beta blockers and other hypertension drugs - the class behind the large valsartan and losartan nitrosamine recalls.

548 recalls in this category, newest first.

Class III · Low risk Terminated Apr 17, 2014

Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count…

Reason Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.

Wockhardt Usa Inc. NDC 64679-735-02 D-0304-2015

Class II · Moderate risk Terminated Apr 14, 2014

LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactured by Arrow Pharm (Malta) Ltd., Bizebbugia, Malta…

Reason Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning

Golden State Medical Supply Inc. NDC 60429-317-30 D-1357-2014

Class II · Moderate risk Terminated Apr 10, 2014

Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited…

Reason Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.

Wockhardt Usa Inc. D-1355-2014

Class II · Moderate risk Terminated Apr 1, 2014

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai…

Reason Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.

Wockhardt Usa Inc. NDC 64679-735-09 D-1300-2014

Class II · Moderate risk Terminated Dec 13, 2013

Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tablets Rx Only Mfd. By: Dr. Reddy's Laboratories…

Reason Failed Dissolution Specification; 12-Month stability interval.

Dr. Reddy's Laboratories, Inc. NDC 55111-467-01 D-1080-2014

Class II · Moderate risk Terminated Nov 1, 2013

Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, Distributed by: GREENSTONE LLC, Pespack, NJ,07977…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Extended Release tablets (90mg). The expiration date on…

Greenstone Llc NDC 59762-6692-8 D-737-2014

Class II · Moderate risk Terminated Oct 11, 2013

Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC…

Reason Subpotent; Hydrochlorothiazide at the 9 month time point.

Sandoz Inc NDC 0185-0341-01 D-393-2014

Class II · Moderate risk Terminated Sep 17, 2013

Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b)…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-452-20 D-1468-2016

Class II · Moderate risk Terminated Sep 17, 2013

Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b)…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-451-20 D-1467-2016

Class II · Moderate risk Terminated Sep 17, 2013

Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-450-20 D-1466-2016

Class II · Moderate risk Terminated Sep 13, 2013

Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-5210-77 D-66403-012

Class II · Moderate risk Terminated Sep 13, 2013

Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-6900-01 D-66403-010

Class II · Moderate risk Terminated Sep 13, 2013

Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC#…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-6898-01 D-66403-009

Class II · Moderate risk Terminated Sep 13, 2013

Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-6899-01 D-66403-008

Class II · Moderate risk Terminated Sep 13, 2013

Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles (NDC 0378-6897-01) and b) 500-count…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-6897-01 D-66403-007

Class II · Moderate risk Terminated Sep 13, 2013

Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b) 500-count…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-6896-01 D-66403-006

Class II · Moderate risk Terminated Sep 13, 2013

Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC 0378-5209-77) and b) 500-count bottles (NDC…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-5209-77 D-66403-005

Class II · Moderate risk Terminated Sep 13, 2013

Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-6895-01 D-66403-002

Class II · Moderate risk Terminated Sep 13, 2013

Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC…

Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Mylan Pharmaceuticals Inc. NDC 0378-5208-77 D-66403-001

Class II · Moderate risk Terminated Aug 8, 2013

Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only…

Reason Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL…

Novartis Pharmaceuticals Corp. NDC 0078-9524-89 D-340-2014

Class II · Moderate risk Terminated Aug 8, 2013

Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx…

Reason Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL…

Novartis Pharmaceuticals Corp. NDC 0078-9521-89 D-339-2014

Class II · Moderate risk Terminated Aug 8, 2013

Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale…

Reason Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL…

Novartis Pharmaceuticals Corp. NDC 0078-9491-07 D-334-2014

Class II · Moderate risk Terminated Aug 8, 2013

Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale…

Reason Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL…

Novartis Pharmaceuticals Corp. NDC 0078-9489-07 D-333-2014

Class II · Moderate risk Terminated Aug 8, 2013

Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For…

Reason Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL…

Novartis Pharmaceuticals Corp. NDC 0078-9560-89 D-332-2014

Class II · Moderate risk Terminated Aug 8, 2013

Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For…

Reason Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL…

Novartis Pharmaceuticals Corp. NDC 0078-9559-89 D-331-2014