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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 1,021–1,040 of 18,047 drug recalls

Drug Recall Ongoing Historical recordClass II

RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01

by Cardinal Health Inc.

Reason
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Recall initiated
July 30, 2025
Reported by FDA
August 13, 2025
Distribution
Nationwide Within the U.S.

View recall →

Drug Recall Ongoing Historical recordClass II

Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55

by Cardinal Health Inc.

Reason
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Recall initiated
July 30, 2025
Reported by FDA
August 13, 2025
Distribution
Nationwide Within the U.S.

View recall →

Drug Recall Ongoing Historical recordClass II

Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.

by Cardinal Health Inc.

Reason
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Recall initiated
July 30, 2025
Reported by FDA
August 13, 2025
Distribution
Nationwide Within the U.S.

View recall →

Drug Recall Ongoing Historical recordClass II

Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,

by Direct Rx

Reason
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Recall initiated
March 7, 2025
Reported by FDA
August 13, 2025
Distribution
Nationwide

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Drug Recall Ongoing Historical recordClass II

Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30

by Direct Rx

Reason
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Recall initiated
March 7, 2025
Reported by FDA
August 13, 2025
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31

by Alembic Pharmaceuticals Limited

Reason
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Recall initiated
July 25, 2025
Reported by FDA
August 13, 2025
Distribution
Nationwide in the USA.

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Drug Recall Ongoing Historical recordClass II

Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

by AEQUITA PHARMACY

Reason
Lack of Processing Controls.
Recall initiated
July 18, 2025
Reported by FDA
August 13, 2025
Distribution
MA

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Drug Recall Ongoing Historical recordClass II

Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

by AEQUITA PHARMACY

Reason
Lack of Processing Controls.
Recall initiated
July 18, 2025
Reported by FDA
August 13, 2025
Distribution
MA

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Drug Recall Ongoing Historical recordClass II

Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

by AEQUITA PHARMACY

Reason
Lack of Processing Controls.
Recall initiated
July 18, 2025
Reported by FDA
August 13, 2025
Distribution
MA

View recall →

Drug Recall Ongoing Historical recordClass II

Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

by AEQUITA PHARMACY

Reason
Lack of Processing Controls.
Recall initiated
July 18, 2025
Reported by FDA
August 13, 2025
Distribution
MA

View recall →

Drug Recall Ongoing Historical recordClass II

Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

by AEQUITA PHARMACY

Reason
Lack of Processing Controls.
Recall initiated
July 18, 2025
Reported by FDA
August 13, 2025
Distribution
MA

View recall →

Drug Recall Ongoing Historical recordClass II

Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

by AEQUITA PHARMACY

Reason
Lack of Processing Controls.
Recall initiated
July 18, 2025
Reported by FDA
August 13, 2025
Distribution
MA

View recall →

Drug Recall Ongoing Historical recordClass II

Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

by AEQUITA PHARMACY

Reason
Lack of Processing Controls.
Recall initiated
July 18, 2025
Reported by FDA
August 13, 2025
Distribution
MA

View recall →

Drug Recall Ongoing Historical recordClass II

Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

by AEQUITA PHARMACY

Reason
Lack of Processing Controls.
Recall initiated
July 18, 2025
Reported by FDA
August 13, 2025
Distribution
MA

View recall →

Drug Recall Ongoing Historical recordClass II

Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

by AEQUITA PHARMACY

Reason
Lack of Processing Controls.
Recall initiated
July 18, 2025
Reported by FDA
August 13, 2025
Distribution
MA

View recall →

Drug Recall Ongoing Historical recordClass II

Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

by AEQUITA PHARMACY

Reason
Lack of Processing Controls.
Recall initiated
July 18, 2025
Reported by FDA
August 13, 2025
Distribution
MA

View recall →

Drug Recall Ongoing Historical recordClass II

Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

by AEQUITA PHARMACY

Reason
Lack of Processing Controls.
Recall initiated
July 18, 2025
Reported by FDA
August 13, 2025
Distribution
MA

View recall →

Drug Recall Ongoing Historical recordClass II

Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

by AEQUITA PHARMACY

Reason
Lack of Processing Controls.
Recall initiated
July 18, 2025
Reported by FDA
August 13, 2025
Distribution
MA

View recall →

Drug Recall Ongoing Historical recordClass II

Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

by AEQUITA PHARMACY

Reason
Lack of Processing Controls.
Recall initiated
July 18, 2025
Reported by FDA
August 13, 2025
Distribution
MA

View recall →

Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.

by Breckenridge Pharmaceutical, Inc.

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Recall initiated
July 15, 2025
Reported by FDA
August 13, 2025
Distribution
U.S Nationwide

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.

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