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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 2,161–2,180 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-014-13.

by AMMAN PHARMACEUTICAL INDUSTRIES

Reason
Lack of Assurance of Sterility
Recall initiated
September 1, 2023
Reported by FDA
September 27, 2023
Distribution
Product was distributed to two (2) direct accounts in RI and CO.

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-095-19.

by AMMAN PHARMACEUTICAL INDUSTRIES

Reason
Lack of Assurance of Sterility
Recall initiated
September 1, 2023
Reported by FDA
September 27, 2023
Distribution
Product was distributed to two (2) direct accounts in RI and CO.

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-058-15.

by AMMAN PHARMACEUTICAL INDUSTRIES

Reason
Lack of Assurance of Sterility
Recall initiated
September 1, 2023
Reported by FDA
September 27, 2023
Distribution
Product was distributed to two (2) direct accounts in RI and CO.

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-094-19.

by AMMAN PHARMACEUTICAL INDUSTRIES

Reason
Lack of Assurance of Sterility
Recall initiated
September 1, 2023
Reported by FDA
September 27, 2023
Distribution
Product was distributed to two (2) direct accounts in RI and CO.

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-013-15.

by AMMAN PHARMACEUTICAL INDUSTRIES

Reason
Lack of Assurance of Sterility
Recall initiated
September 1, 2023
Reported by FDA
September 27, 2023
Distribution
Product was distributed to two (2) direct accounts in RI and CO.

View recall →

Drug Recall Ongoing Historical recordClass II

MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, Made in Jordan, NDC: 0904-6488-38.

by AMMAN PHARMACEUTICAL INDUSTRIES

Reason
Lack of Assurance of Sterility
Recall initiated
September 1, 2023
Reported by FDA
September 27, 2023
Distribution
Product was distributed to two (2) direct accounts in RI and CO.

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-098-15.

by AMMAN PHARMACEUTICAL INDUSTRIES

Reason
Lack of Assurance of Sterility
Recall initiated
September 1, 2023
Reported by FDA
September 27, 2023
Distribution
Product was distributed to two (2) direct accounts in RI and CO.

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-165-13.

by AMMAN PHARMACEUTICAL INDUSTRIES

Reason
Lack of Assurance of Sterility
Recall initiated
September 1, 2023
Reported by FDA
September 27, 2023
Distribution
Product was distributed to two (2) direct accounts in RI and CO.

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-417-19.

by AMMAN PHARMACEUTICAL INDUSTRIES

Reason
Lack of Assurance of Sterility
Recall initiated
September 1, 2023
Reported by FDA
September 27, 2023
Distribution
Product was distributed to two (2) direct accounts in RI and CO.

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-096-19.

by AMMAN PHARMACEUTICAL INDUSTRIES

Reason
Lack of Assurance of Sterility
Recall initiated
September 1, 2023
Reported by FDA
September 27, 2023
Distribution
Product was distributed to two (2) direct accounts in RI and CO.

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes, Dryness Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC:17312-178-15.

by AMMAN PHARMACEUTICAL INDUSTRIES

Reason
Lack of Assurance of Sterility
Recall initiated
September 1, 2023
Reported by FDA
September 27, 2023
Distribution
Product was distributed to two (2) direct accounts in RI and CO.

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-002-11.

by AMMAN PHARMACEUTICAL INDUSTRIES

Reason
Lack of Assurance of Sterility
Recall initiated
September 1, 2023
Reported by FDA
September 27, 2023
Distribution
Product was distributed to two (2) direct accounts in RI and CO.

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-097-19.

by AMMAN PHARMACEUTICAL INDUSTRIES

Reason
Lack of Assurance of Sterility
Recall initiated
September 1, 2023
Reported by FDA
September 27, 2023
Distribution
Product was distributed to two (2) direct accounts in RI and CO.

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-032-15.

by AMMAN PHARMACEUTICAL INDUSTRIES

Reason
Lack of Assurance of Sterility
Recall initiated
September 1, 2023
Reported by FDA
September 27, 2023
Distribution
Product was distributed to two (2) direct accounts in RI and CO.

View recall →

Drug Recall Ongoing Historical recordClass II

TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-027-15.

by AMMAN PHARMACEUTICAL INDUSTRIES

Reason
Lack of Assurance of Sterility
Recall initiated
September 1, 2023
Reported by FDA
September 27, 2023
Distribution
Product was distributed to two (2) direct accounts in RI and CO.

View recall →

Drug Recall Terminated Historical recordClass I

WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5

by Hua Da Trading, Inc. dba Wefun Inc.

Reason
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Recall initiated
August 25, 2023
Reported by FDA
September 20, 2023
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-305-16

by VistaPharm LLC

Reason
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Recall initiated
August 30, 2023
Reported by FDA
September 20, 2023
Distribution
Distributed nationwide to 68 consignees in the U.S.

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Drug Recall Terminated Historical recordClass II

Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in India for and Distributed by: BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511.

by BE PHARMACEUTICALS AG

Reason
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Recall initiated
September 5, 2023
Reported by FDA
September 20, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01

by Marlex Pharmaceuticals, Inc.

Reason
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Recall initiated
August 25, 2023
Reported by FDA
September 13, 2023
Distribution
Nationwide in the US.

View recall →

Drug Recall Terminated Historical recordClass I

Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01

by Marlex Pharmaceuticals, Inc.

Reason
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Recall initiated
August 25, 2023
Reported by FDA
September 13, 2023
Distribution
Nationwide in the US.

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.