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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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Drug Recall Terminated Historical recordClass II

Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30

by PD-Rx Pharmaceuticals, Inc.

Reason: CGMP deviations.
Recall initiated: April 6, 2023
Reported by FDA: May 10, 2023
Distribution: Nationwide in the US.

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Drug Recall Ongoing Historical recordClass III

Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories UT, Inc., Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504 USA

by Bryant Ranch Prepack, Inc.

Reason: Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
Recall initiated: April 20, 2023
Reported by FDA: May 10, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1

by Sun Pharmaceutical Industries Ltd.

Reason: Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Recall initiated: April 19, 2023
Reported by FDA: May 3, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44

by SCA Pharmaceuticals

Reason: Subpotent Drug: Out of specification results for low potency was obtained.
Recall initiated: April 10, 2023
Reported by FDA: May 3, 2023
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-487-52

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 Ongoing Historical recordClass II

Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.

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 Ongoing Historical recordClass II

Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.

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 Ongoing Historical recordClass II

Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.

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 Ongoing Historical recordClass II

Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-109-52

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 Ongoing Historical recordClass II

BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-511-52

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 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

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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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Data last updated: November 2, 2026 ET

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.