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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 2,221–2,240 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recall initiated
August 17, 2023
Reported by FDA
September 6, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0103-1

by Central Admixture Pharmacy Services, Inc.

Reason
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recall initiated
August 17, 2023
Reported by FDA
September 6, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.

by TMC Acquisitions LLC dba Tailor Made Compounding

Reason
Lack of Assurance of Sterility
Recall initiated
August 15, 2023
Reported by FDA
August 30, 2023
Distribution
Nationwide within the USA

View recall →

Drug Recall Terminated Historical recordClass II

Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.

by TMC Acquisitions LLC dba Tailor Made Compounding

Reason
Lack of Assurance of Sterility
Recall initiated
August 15, 2023
Reported by FDA
August 30, 2023
Distribution
Nationwide within the USA

View recall →

Drug Recall Ongoing Historical recordClass II

All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.

by Inmar Supply Chain Solutions, LLC

Reason
CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling.
Recall initiated
August 14, 2023
Reported by FDA
August 30, 2023
Distribution
Separate Distribution List (salvage buyers) provided by Inmar and will be uploaded. Final customer distribution unknown.

View recall →

Drug Recall Completed Historical recordClass III

Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.

by Baxter Healthcare Corporation

Reason
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Recall initiated
August 14, 2023
Reported by FDA
August 30, 2023
Distribution
Nationwide in the U.S.A.

View recall →

Drug Recall Completed Historical recordClass II

Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6064-0, Ref 6064.

by Ecometics, Inc.

Reason
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Recall initiated
August 9, 2023
Reported by FDA
August 30, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Completed Historical recordClass II

AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.

by Ecometics, Inc.

Reason
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Recall initiated
August 9, 2023
Reported by FDA
August 30, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Completed Historical recordClass II

activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution, Net 1 FL. OZ., Manufactured for: All USA Direct, LLC, Broadview, IL 60155.

by Ecometics, Inc.

Reason
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Recall initiated
August 9, 2023
Reported by FDA
August 30, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Completed Historical recordClass II

Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NET WT 1 OZ (28 g) tubes, Improved Formula, UPC 0 11169 10216 0, and b) NET WT 1 OZ (28.3g) tubes, Maximum Strength, UPC 0 11169 11250 3, Distributed by: Oakhurst Company, Levittown, NY 11756.

by Ecometics, Inc.

Reason
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Recall initiated
August 9, 2023
Reported by FDA
August 30, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Completed Historical recordClass II

ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 ml) bottles, UPC 7 18864 20102 9 and b) 16 FLUID OZ (472 ml) bottles, UPC 7 18864, 20110 4, Distributed by: The Larkspur Group, Inc., Norwalk, CT 06854.

by Ecometics, Inc.

Reason
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Recall initiated
August 9, 2023
Reported by FDA
August 30, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Completed Historical recordClass II

YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, packaged in a) 4 FL OZ (118 mL) bottles, UPC 0 11169 00004 6, and 8 FL OZ (236 mL) bottles, UPC 0 11169 00008 4, The Oakhurst Co., Dist., Levittown, NY 11756.

by Ecometics, Inc.

Reason
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Recall initiated
August 9, 2023
Reported by FDA
August 30, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Completed Historical recordClass II

Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ. (54.5 mL) bottles, UPC 0 11169 20012 5, Distributed by Oakhurst Company, Levittown, NY 11756.

by Ecometics, Inc.

Reason
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Recall initiated
August 9, 2023
Reported by FDA
August 30, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass III

Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01

by Glenmark Pharmaceuticals Inc., USA

Reason
Subpotent: Out of Specification for Assay Test at the 3-month time point.
Recall initiated
August 14, 2023
Reported by FDA
August 30, 2023
Distribution
nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass III

Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05.

by Imprimis NJOF, LLC

Reason
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Recall initiated
August 10, 2023
Reported by FDA
August 30, 2023
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775-054-01), b)2 fl. oz. tubes (NDC 30775-054-02), and c) 4 fl. oz. tubes (NDC 30775-054-04), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004

by Parker Laboratories, Inc.

Reason
CGMP Deviations
Recall initiated
August 2, 2023
Reported by FDA
August 30, 2023
Distribution
Nationwide within the United States, Singapore, Korea and Hong Kong

View recall →

Drug Recall Terminated Historical recordClass II

Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. tubes (NDC 30775-053-04), Parker Laboratories Inc., Fairfield, NJ, 07004

by Parker Laboratories, Inc.

Reason
CGMP Deviations
Recall initiated
August 2, 2023
Reported by FDA
August 30, 2023
Distribution
Nationwide within the United States, Singapore, Korea and Hong Kong

View recall →

Drug Recall Terminated Historical recordClass II

Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (NDC 30775-052-03) and b) 4 fl. oz. tube (NDC 30775-052-04) Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004

by Parker Laboratories, Inc.

Reason
CGMP Deviations
Recall initiated
August 2, 2023
Reported by FDA
August 30, 2023
Distribution
Nationwide within the United States, Singapore, Korea and Hong Kong

View recall →

Drug Recall Terminated Historical recordClass II

Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03), c) 4 fl. oz. tubes (NDC 30775-051-04), d) 12 fl oz pump bottles (NDC 30775-051-12), e) 32 fl. oz. pump bottles (NDC 30775-051-32), f) 1 U.S. gallon with pump (NDC 30775-051-50), g) Starter Kit (NDC 30775-051-95), Parker Laboratories, Inc. 286 Eldridge Road Fairfield, NJ 07004

by Parker Laboratories, Inc.

Reason
CGMP Deviations
Recall initiated
August 2, 2023
Reported by FDA
August 30, 2023
Distribution
Nationwide within the United States, Singapore, Korea and Hong Kong

View recall →

Drug Recall Terminated Historical recordClass II

Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottles (NDC 30775-040-02) and b)18 fl. oz./550 ml Pump Bottles (NDC 30775-040-18), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004

by Parker Laboratories, Inc.

Reason
CGMP Deviations
Recall initiated
August 2, 2023
Reported by FDA
August 30, 2023
Distribution
Nationwide within the United States, Singapore, Korea and Hong Kong

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.