Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Amlodipine recalled?

Yes — there is an active recall. 32 ongoing FDA recalls mention Amlodipine (95 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Amlodipine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Amlodipine recalls on record

none so far in 2026; 95 on record, newest first
Class II · Moderate risk

Amlodipine Besylate Tablets

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

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-5210-77 D-66403-012
Class II · Moderate risk

Amlodipine Besylate and Benazepril HCl Capsules

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

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-6900-01 D-66403-010
Class II · Moderate risk

Amlodipine Besylate and Benazepril HCl Capsules

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

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-6898-01 D-66403-009
Class II · Moderate risk

Amlodipine Besylate and Benazepril HCl Capsules

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

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-6899-01 D-66403-008
Class II · Moderate risk

Amlodipine Besylate and Benazepril HCl Capsules

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

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-6897-01 D-66403-007
Class II · Moderate risk

Amlodipine Besylate and Benazepril HCl Capsules

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

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-6896-01 D-66403-006
Class II · Moderate risk

Amlodipine Besylate Tablets

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

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-5209-77 D-66403-005
Class II · Moderate risk

Amlodipine Besylate and Benazepril HCl Capsules

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

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-6895-01 D-66403-002
Class II · Moderate risk

Amlodipine Besylate Tablets

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

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-5208-77 D-66403-001
Class II · Moderate risk

Exforge (amlodipine and valsartan, Tablets)

Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.

Terminated Chemical / undeclared Novartis Pharmaceuticals Corp. NDC 0078-9491-07 D-334-2014
Class II · Moderate risk

Exforge (amlodipine and valsartan Tablets)

Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.

Terminated Chemical / undeclared Novartis Pharmaceuticals Corp. NDC 0078-9489-07 D-333-2014
Class II · Moderate risk

Exforge HCT

Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.

Terminated Chemical / undeclared Novartis Pharmaceuticals Corp. NDC 0078-9560-89 D-332-2014
Class II · Moderate risk

Exforge HCT

Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.

Terminated Chemical / undeclared Novartis Pharmaceuticals Corp. NDC 0078-9559-89 D-331-2014
Class II · Moderate risk

Exforge HCT

Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.

Terminated Chemical / undeclared Novartis Pharmaceuticals Corp. NDC 0078-9563-89 D-330-2014
Class II · Moderate risk

Exforge (amlodipine and valsartan Tablets)

Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.

Terminated Chemical / undeclared Novartis Pharmaceuticals Corp. NDC 0078-9490-07 D-329-2014
Class II · Moderate risk

Exforge (amlodipine and valsartan Tablets)

Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.

Terminated Chemical / undeclared Novartis Pharmaceuticals Corp. NDC 0078-9488-07 D-328-2014
Class II · Moderate risk

amLODIPine BESYLATE

Labeling: Label Mixup: amLODIPine BESYLATE, Tablet, 5 mg may have potentially been mislabeled as the following drug: CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: W002839, EXP: 6/7/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-843-2014
Class II · Moderate risk

amLODIPine BESYLATE

Labeling:Label Mixup; amLODIPine BESYLATE, Tablet, 10 mg may be potentially mislabeled as FINASTERIDE, Tablet, 5 mg, NDC 16714052201, Pedigree: AD62846_1, EXP: 2/28/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-726-2014
Class II · Moderate risk

Walmart Amlodipine Besylate Tablets

Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine 10 mg label, 5 mg is listed in the USP description. Tablet strength is 10 mg.

Terminated Labeling / mix-up Legacy Pharmaceutical Packaging LLC NDC 68645-445-70 D-319-2013