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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 2,781–2,800 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass II

Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-946-52

by Northwind Pharmaceuticals LLC

Reason
CGMP Deviations
Recall initiated
March 16, 2023
Reported by FDA
May 3, 2023
Distribution
Nationwide with the United States

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Drug Recall Terminated Historical recordClass III

Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark.

by DuPont Nutrition USA, Inc

Reason
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Recall initiated
April 13, 2023
Reported by FDA
May 3, 2023
Distribution
Nationwide in the USA, Malta, Canada, China, Peru, Mexico, Australia, Saudi Arabia, Spain, Dominican Republic, Puerto Rico, Singapore, Bangkok, Ireland, India, and Columbia.

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Drug Recall Terminated Historical recordClass III

Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark.

by DuPont Nutrition USA, Inc

Reason
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Recall initiated
April 13, 2023
Reported by FDA
May 3, 2023
Distribution
Nationwide in the USA, Malta, Canada, China, Peru, Mexico, Australia, Saudi Arabia, Spain, Dominican Republic, Puerto Rico, Singapore, Bangkok, Ireland, India, and Columbia.

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Drug Recall Terminated Historical recordClass III

Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark.

by DuPont Nutrition USA, Inc

Reason
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Recall initiated
April 13, 2023
Reported by FDA
May 3, 2023
Distribution
Nationwide in the USA, Malta, Canada, China, Peru, Mexico, Australia, Saudi Arabia, Spain, Dominican Republic, Puerto Rico, Singapore, Bangkok, Ireland, India, and Columbia.

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Drug Recall Terminated Historical recordClass III

Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark.

by DuPont Nutrition USA, Inc

Reason
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Recall initiated
April 13, 2023
Reported by FDA
May 3, 2023
Distribution
Nationwide in the USA, Malta, Canada, China, Peru, Mexico, Australia, Saudi Arabia, Spain, Dominican Republic, Puerto Rico, Singapore, Bangkok, Ireland, India, and Columbia.

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Drug Recall Completed Historical recordClass II

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04.

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Recall initiated
March 15, 2023
Reported by FDA
May 3, 2023
Distribution
Nationwide in the USA

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Drug Recall Completed Historical recordClass II

Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Container bag, Product Code L5B4826, NDC 0941-0409-07; and b) 6000 mL per Ambu-Flex II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Recall initiated
March 15, 2023
Reported by FDA
May 3, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx

by Wellness BioSciences

Reason
Marketed Without an Approved NDA/ANDA
Recall initiated
April 1, 2022
Reported by FDA
May 3, 2023
Distribution
Nationwide within the United States

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Drug Recall Completed Historical recordClass II

Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral Springs, FL, 33065, NDC 67850-150-10 (carton), NDC 67850-150-00 (vial).

by Methapharm Inc

Reason
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Recall initiated
April 7, 2023
Reported by FDA
May 3, 2023
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05

by Ascend Laboratories, LLC

Reason
Out of specification (OOS) for Spectroscopic Identification test by IR.
Recall initiated
March 17, 2023
Reported by FDA
April 26, 2023
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 39402

by Pharmacy Plus, Inc. dba Vital Care Compounder

Reason
Lack of assurance of sterility.
Recall initiated
April 13, 2023
Reported by FDA
April 26, 2023
Distribution
MS only

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Drug Recall Ongoing Historical recordClass II

Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, CVS Product # 999532, UPC 0 50428 36475 8.

by Pharma Nobis LLC

Reason
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Recall initiated
April 6, 2023
Reported by FDA
April 26, 2023
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-504-01; NDC Unit Dose: 60687-504-11, barcode (01) 003 60687 504 11 7.

by Amerisource Health Services LLC

Reason
Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Recall initiated
March 16, 2023
Reported by FDA
April 26, 2023
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for: Focus Health Group, 5802 Kingston Pike, Knoxville, TN 37919. Incorrect NDC (kit): 24357-011-13

by Focus Health Group Inc

Reason
Labeling; Incorrect NDC number on outer carton of product.
Recall initiated
March 16, 2023
Reported by FDA
April 19, 2023
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc., Boulder, CO 80301. NDC: 70255-010-02

by Pfizer Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
Recall initiated
March 8, 2023
Reported by FDA
April 19, 2023
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in individually labeled poly envelopes (primary packaging). Repackaged by Pine Pharmaceuticals, Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150, Office Use Only, Not for Resale. Secondary packaging consists of a coated cardboard box, with order-specific label indicating lot number housed within order/container. NDC # 69194-0458-1

by Pine Pharmaceuticals, LLC

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Recall initiated
March 27, 2023
Reported by FDA
April 19, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10

by Hetero USA Inc

Reason
CGMP Deviations: Discoloration
Recall initiated
March 14, 2023
Reported by FDA
April 19, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packaged in 10 x 4 mL Single-dose Fliptop Vials per carton (NDC 47335-615-44); Rx only, Manufactured by: Gland Pharma Limited, Hyderabad-502307 India; Distributed by: Sun Phamaceutical Industries, Inc., Cranbury, NJ 08512.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Recall initiated
March 29, 2023
Reported by FDA
April 19, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx Only, Sterile, Manufactured by: Intas Pharmaceuticals Limited Pharmaz Ahnedabad 382 213, INDIA, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-533-08.

by ACCORD HEALTHCARE, INC.

Reason
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Recall initiated
March 29, 2023
Reported by FDA
April 12, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass II

Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9

by Preferred Pharmaceuticals, Inc.

Reason
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall initiated
March 23, 2023
Reported by FDA
April 12, 2023
Distribution
USA 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.