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

Not under an active recall. Benazepril was recalled 13 times in the past — all now closed. Most recent: Jul 2, 2025.

Most common reason: cGMP deviation (6 of these recalls)

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

Benazepril recalls on record

none so far in 2026; 13 on record, newest first
Class III · Low risk

Benazepril HCl Tablets

Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle

Terminated Particulate / foreign matter Amneal Pharmaceuticals, Inc. NDC 65162-754-10 D-0134-2020
Class II · Moderate risk

Benazepril HCl active pharmaceutical ingredient packaged in…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-537-2015
Class II · Moderate risk

Benazepril active pharmaceutical ingredient packaged in varying…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-536-2015
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 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

BENAZEPRIL HCL Tablet

Labeling:Label Mixup; BENAZEPRIL HCL Tablet, 40 mg may be potentially mislabeled as NEFAZODONE HCL, Tablet, 200 mg, NDC 00093102506, Pedigree: AD46414_44, EXP: 5/16/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003931, EXP: 6/28/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD42592_1, EXP: 5/14/2014; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/25

Terminated Labeling / mix-up Aidapak Services, LLC D-713-2014
Class II · Moderate risk

BENAZEPRIL HCL Tablet

Labeling:Label Mixup; BENAZEPRIL HCL Tablet, 5 mg may be potentially mislabeled as ZINC SULFATE, Capsule, 220 mg, NDC 60258013101, Pedigree: AD52993_34, EXP: 5/20/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-712-2014