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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 2,961–2,980 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-305-10.

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
February 22, 2023
Reported by FDA
March 8, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-302-10.

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
February 22, 2023
Reported by FDA
March 8, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-315-25.

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
February 22, 2023
Reported by FDA
March 8, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-319-25.

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
February 22, 2023
Reported by FDA
March 8, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-316-25.

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
February 22, 2023
Reported by FDA
March 8, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15.

by Nephron Sterile Compounding Center LLC

Reason
Lack of Assurance of Sterility
Recall initiated
February 22, 2023
Reported by FDA
March 8, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, 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. 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
February 1, 2023
Reported by FDA
March 8, 2023
Distribution
Product was distributed nationwide in the United States and Puerto Rico, and to Australia, China, Canada, Columbia, Mexico, Brazil, Malaysia, Chile, Dominic Republic, Singapore, Thailand, Ireland, Germany, South Korea, Argentina, Pakistan, Oman, India

View recall →

Drug Recall Terminated Historical recordClass III

Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, 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. 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
February 1, 2023
Reported by FDA
March 8, 2023
Distribution
Product was distributed nationwide in the United States and Puerto Rico, and to Australia, China, Canada, Columbia, Mexico, Brazil, Malaysia, Chile, Dominic Republic, Singapore, Thailand, Ireland, Germany, South Korea, Argentina, Pakistan, Oman, India

View recall →

Drug Recall Terminated Historical recordClass III

Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. 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. 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
February 1, 2023
Reported by FDA
March 8, 2023
Distribution
Product was distributed nationwide in the United States and Puerto Rico, and to Australia, China, Canada, Columbia, Mexico, Brazil, Malaysia, Chile, Dominic Republic, Singapore, Thailand, Ireland, Germany, South Korea, Argentina, Pakistan, Oman, India

View recall →

Drug Recall Terminated Historical recordClass I

PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1.

by Volt Candy Wholesale Club

Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Recall initiated
February 13, 2023
Reported by FDA
March 8, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-232-01, UPC 3 16729 23201 2;

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Bottle NDC 16729-467-15, UPC 3 16729 46715 5; Carton NDC 16729-467-85, UPC 3 16729 46785 8.

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b) 90-count bottle NDC 16729-119-15 UPC 3 16729 11915 3; c) 1,000-count bottle NDC 16729-119-17 UPC 3 16729 11917 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-491-12 UPC 3 16729 49112 9

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-289-12 UPC 3 16729 28912 2

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500 Tablets NDC 16729-047-16 UPC 3 16729 04716 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,000 Tablets NDC 16729-046-17 UPC 3 16729 04617 6, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

by ACCORD HEALTHCARE, INC.

Reason
CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated
February 7, 2023
Reported by FDA
March 8, 2023
Distribution
United States including Puerto Rico and Canada

View recall →

Drug Recall Terminated Historical recordClass III

Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.

by Sciegen Pharmaceuticals Inc

Reason
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Recall initiated
February 17, 2023
Reported by FDA
March 8, 2023
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058, NDC 47781-654-90.

by Alvogen, Inc

Reason
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Recall initiated
February 6, 2023
Reported by FDA
March 8, 2023
Distribution
Nationwide and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass III

BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp., 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. 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
February 1, 2023
Reported by FDA
March 8, 2023
Distribution
Product was distributed nationwide in the United States and Puerto Rico, and to Australia, China, Canada, Columbia, Mexico, Brazil, Malaysia, Chile, Dominic Republic, Singapore, Thailand, Ireland, Germany, South Korea, Argentina, Pakistan, Oman, India

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.