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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 5,441–5,460 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Lite'n Foamy Healthcare Personnel Handwash (Chloroxylenol, 1.0%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26283 0 NDC: 64009-335-82

by Spartan Chemical Co Inc

Reason
CGMP Deviations
Recall initiated
March 29, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide USA and Puerto Rico; Mexico

View recall →

Drug Recall Terminated Historical recordClass II

Lite'n Foamy Eucalyptus Mint Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53525 26287 8 NDC: 64009-332-72

by Spartan Chemical Co Inc

Reason
CGMP Deviations
Recall initiated
March 29, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide USA and Puerto Rico; Mexico

View recall →

Drug Recall Terminated Historical recordClass II

Lite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26116 1 NDC: 64009-333-95

by Spartan Chemical Co Inc

Reason
CGMP Deviations
Recall initiated
March 29, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide USA and Puerto Rico; Mexico

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Drug Recall Terminated Historical recordClass II

Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA.UPC 7 53727 26257 1 NDC: 64009-336-85

by Spartan Chemical Co Inc

Reason
CGMP Deviations
Recall initiated
March 29, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide USA and Puerto Rico; Mexico

View recall →

Drug Recall Terminated Historical recordClass II

foamyiQ Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 42.27 oz/1250 ml per foam pump cartridge, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26454 4 NDC: 64009-202-06

by Spartan Chemical Co Inc

Reason
CGMP Deviations
Recall initiated
March 29, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide USA and Puerto Rico; Mexico

View recall →

Drug Recall Terminated Historical recordClass I

Lite'n Foamy Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26288 5 SKU# 333806 NDC: 64009-331-82

by Spartan Chemical Co Inc

Reason
Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans
Recall initiated
March 29, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide USA and Puerto Rico; Mexico

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Drug Recall Terminated Historical recordClass II

Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactured by: Mikart, LLC, Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 10631-206-02.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Microbial Contamination of Non-Sterile Product
Recall initiated
March 31, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-282-30.

by Jubilant Cadista Pharmaceuticals, Inc.

Reason
Failed Dissolution Specifications
Recall initiated
April 1, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (when mixed) bottles (NDC 68180-402-02); and c) 100 mL (when mixed) bottles (NDC 68180-402-03); Rx only, Manufactured for: Lupin Pharmaceutical, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Mandideep 462 046, India.

by Lupin Pharmaceuticals Inc.

Reason
Superpotent Drug
Recall initiated
March 26, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC 52565-008-14.

by Teligent Pharma, Inc.

Reason
Failed Stability Specifications: product did not meet viscosity results.
Recall initiated
March 29, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC: 69306-004-21, Relabeled by: Enovachem Pharmaceuticals 379 Van Ness Ave. Suite 1403-1406, Torrance, CA 90501, Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Source NDC: 59746-001-03, DocRx, Mobile, AL 36608

by Asclemed USA Inc. dba Enovachem Pharmaceuticals

Reason
Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.
Recall initiated
March 19, 2021
Reported by FDA
April 21, 2021
Distribution
Distributed to three physicians in the following states: CA, LA (Enovachem). DocRx distributed recalled product to one Distributor located in AL.

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Drug Recall Terminated Historical recordClass III

Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Daman (U.T.), India, NDC 33342-114-10

by Macleods Pharma Usa Inc

Reason
Failed Impurities/Degradation Specifications
Recall initiated
March 22, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5

by X-Gen Pharmaceuticals Inc.

Reason
Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
Recall initiated
March 19, 2021
Reported by FDA
April 14, 2021
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080

by Cosette Pharmaceuticals, Inc.

Reason
CGMP Deviaitons
Recall initiated
March 25, 2021
Reported by FDA
April 14, 2021
Distribution
Nationwide in the US

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Drug Recall Terminated Historical recordClass I

Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30

by Alembic Pharmaceuticals Limited

Reason
Labeling: Label-mixup
Recall initiated
March 17, 2021
Reported by FDA
April 14, 2021
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass III

Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda HIghway, Halol-389 350 Gujarat, India, NDC 62756-142-02.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Moisture Limits: Out of specification for water content
Recall initiated
March 25, 2021
Reported by FDA
April 14, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-3928-1, UPC 3 60505 39281 0

by Apotex Corp.

Reason
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Recall initiated
March 31, 2021
Reported by FDA
April 14, 2021
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass III

LCL-2-0191, 5 gallon carboys, Rx only, Manufactured for: LaCore Labs, LLC, by: Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411

by Washington Homeopathic Products, Inc.

Reason
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Recall initiated
March 18, 2021
Reported by FDA
April 14, 2021
Distribution
Product was distributed to MD, CO & TX only

View recall →

Drug Recall Terminated Historical recordClass III

Sp-4, 100 mL solution bottles, Rx only, Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411

by Washington Homeopathic Products, Inc.

Reason
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Recall initiated
March 18, 2021
Reported by FDA
April 14, 2021
Distribution
Product was distributed to MD, CO & TX only

View recall →

Drug Recall Terminated Historical recordClass III

Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for: Natural Ophthalmics Inc. PO Box 1510 Dillon, CO 80435, NDC 58770-190-42

by Washington Homeopathic Products, Inc.

Reason
An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.
Recall initiated
March 18, 2021
Reported by FDA
April 14, 2021
Distribution
Product was distributed to MD, CO & TX only

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.