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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 4,481–4,500 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1427-10

by Edge Pharma, LLC

Reason
Lack of Assurance of Sterility.
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single Use Syringe For Otic Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0848-01

by Edge Pharma, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446 NDC 05446-1003-01

by Edge Pharma, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-0733-01

by Edge Pharma, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, (802) 992-1178, NDC 05446-1268-01

by Edge Pharma, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0850-10

by Edge Pharma, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-0637-03

by Edge Pharma, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 6, 2021
Reported by FDA
February 2, 2022
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, 07054, NDC 67877-590-01.

by Ascend Laboratories, LLC

Reason
Failed Dissolution Specifications.
Recall initiated
January 12, 2022
Reported by FDA
February 2, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01

by VIONA PHARMACEUTICALS INC

Reason
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Recall initiated
December 27, 2021
Reported by FDA
February 2, 2022
Distribution
Product was distributed to 17 wholesalers who further distributed the product to 85 locations.

View recall →

Drug Recall Terminated Historical recordClass II

Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets per Unit Dose Packet, packaged as a) 200-count Tablets (100 x 2) Unit Dose packets per carton, UPC 3 47682 22847 7, Reorder #22847; b) 500-count Tablets (250 x 2) Unit Dose packets per carton, UPC 3 47682 22813 2, Reorder #22813; c) 100-count Tablets (50 x 2) Unit Dose packets per carton, UPC 3 47682 22833 0, Reorder #22833; d) 24-count Tablets (12 x 2) Unit Dose packets per carton, UPC 3 47682 22864 4, Reorder #22864; Manufactured for Medique Products, Fort Myers, FL 33967.

by Medique Products

Reason
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Recall initiated
December 6, 2021
Reported by FDA
January 26, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04

by VistaPharm, Inc.

Reason
Failed Stability Specifications
Recall initiated
January 7, 2022
Reported by FDA
January 26, 2022
Distribution
Nationwide within the United States including Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malaysia for: Mylan Specialty L.P., Morgantown, WV, 26505.

by MYLAN PHARMACEUTICALS INC

Reason
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Recall initiated
January 5, 2022
Reported by FDA
January 26, 2022
Distribution
Nationwide in the USA and Thailand.

View recall →

Drug Recall Terminated Historical recordClass II

Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404

by Medique Products

Reason
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Recall initiated
December 6, 2021
Reported by FDA
January 26, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured for: Acme United Corporation 55 Walls Dr, Fairfield, CT 06824, UPC 0 73577 90316 6

by Medique Products

Reason
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Recall initiated
December 6, 2021
Reported by FDA
January 26, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36-count blister pack packed into cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, Made in India, NDC 0363-164-3

by Dr. Reddy's Laboratories, Inc.

Reason
Subpotent drug
Recall initiated
January 10, 2022
Reported by FDA
January 26, 2022
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50

by Mayne Pharma Inc

Reason
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Recall initiated
January 14, 2022
Reported by FDA
January 26, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by Cardinal Health, Dublin, Ohio 43077, Made in India.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications
Recall initiated
January 4, 2022
Reported by FDA
January 26, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI, 02895, Made in India.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications
Recall initiated
January 4, 2022
Reported by FDA
January 26, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications
Recall initiated
January 4, 2022
Reported by FDA
January 26, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 49035-273-20, b) 30 Extended Release Tablets per box, NDC 49035-273-30, Distributed by: Walmart Inc., Bentonville, AR 72716, Product of India.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications
Recall initiated
January 4, 2022
Reported by FDA
January 26, 2022
Distribution
Nationwide in the USA

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.