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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 881–900 of 17,898 drug recalls

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

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Drug Recall Ongoing Historical recordClass II

Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25

by Hikma Pharmaceuticals USA Inc.

Reason
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Recall initiated
July 22, 2025
Reported by FDA
August 6, 2025
Distribution
Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.

by Nostrum Laboratories, Inc.

Reason
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Recall initiated
July 11, 2025
Reported by FDA
August 6, 2025
Distribution
nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04

by Strides Pharma, Inc.

Reason
Failed Dissolution Specifications.
Recall initiated
July 9, 2025
Reported by FDA
August 6, 2025
Distribution
Product was distributed nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04

by Pfizer Inc.

Reason
CGMP Deviations; particulates identified during visual inspection
Recall initiated
July 10, 2025
Reported by FDA
August 6, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-701-02

by Pfizer Inc.

Reason
CGMP Deviations; particulates identified during visual inspection
Recall initiated
July 10, 2025
Reported by FDA
August 6, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.

by FDC Limited

Reason
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Recall initiated
July 5, 2025
Reported by FDA
August 6, 2025
Distribution
U.S Nationwide.

View recall →

Drug Recall Completed Historical recordClass II

Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.

by Lupin Pharmaceuticals Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Recall initiated
July 2, 2025
Reported by FDA
August 6, 2025
Distribution
Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton)

by Cipla USA, Inc.

Reason
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Recall initiated
June 30, 2025
Reported by FDA
July 30, 2025
Distribution
Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
CGMP Deviations; potential temperature excursions due to transit delays
Recall initiated
April 21, 2025
Reported by FDA
July 30, 2025
Distribution
Within the U.S - OH, VA, FL.

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.