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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 1,781–1,800 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10

by Mckesson Medical-Surgical Inc. Corporate Office

Reason
cGMP Deviations: Products were stored outside the drug label specifications.
Recall initiated
February 7, 2024
Reported by FDA
March 20, 2024
Distribution
Product was distributed to three direct accounts in NM, AZ and UT.

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Drug Recall Terminated Historical recordClass II

Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20

by B. Braun Medical Inc

Reason
Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
Recall initiated
March 6, 2024
Reported by FDA
March 20, 2024
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-060-01.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recall initiated
March 4, 2024
Reported by FDA
March 20, 2024
Distribution
Nationwide

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Drug Recall Ongoing Historical recordClass II

Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-059-01.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recall initiated
March 4, 2024
Reported by FDA
March 20, 2024
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com

by Stason Pharmaceuticals, Inc.

Reason
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Recall initiated
February 9, 2024
Reported by FDA
March 13, 2024
Distribution
USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01

by Eugia US LLC

Reason
Failed Dissolution Specifications
Recall initiated
February 20, 2024
Reported by FDA
March 13, 2024
Distribution
OH, TN, LA, MS

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Drug Recall Ongoing Historical recordClass III

Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60

by Contract Pharmaceuticals Limited Canada

Reason
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Recall initiated
February 20, 2024
Reported by FDA
March 13, 2024
Distribution
Nationwide in the U.S. and Puerto Rico

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Drug Recall Ongoing Historical recordClass III

Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61

by Contract Pharmaceuticals Limited Canada

Reason
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Recall initiated
February 20, 2024
Reported by FDA
March 13, 2024
Distribution
Nationwide in the U.S. and Puerto Rico

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Drug Recall Ongoing Historical recordClass II

Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42

by Denver Solutions, LLC DBA Leiters Health

Reason
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Recall initiated
February 20, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42

by Denver Solutions, LLC DBA Leiters Health

Reason
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Recall initiated
February 20, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42

by Denver Solutions, LLC DBA Leiters Health

Reason
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Recall initiated
February 20, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 77471

by Seatex LLC

Reason
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Recall initiated
February 19, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide in the US and Puerto Rico

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Drug Recall Terminated Historical recordClass II

7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033

by Seatex LLC

Reason
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Recall initiated
February 19, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide in the US and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033

by Seatex LLC

Reason
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Recall initiated
February 19, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide in the US and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471

by Seatex LLC

Reason
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Recall initiated
February 19, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide in the US and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471.

by Seatex LLC

Reason
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Recall initiated
February 19, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide in the US and Puerto Rico

View recall →

Drug Recall Completed Historical recordClass II

Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Rx Only, Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, NDC 68682-991-30.

by Bausch Health Companies, Inc.

Reason
Subpotent Drug: Out of specification for assay
Recall initiated
February 2, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE Pharmaceuticals, Inc., Fairfield, NJ 07004, NDC 71406-124-35, UPC 371406124356

by Brassica Pharma Pvt Ltd

Reason
Lack of Assurance of Sterility
Recall initiated
January 30, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram tubes, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 76168-707-35, UPC 050428634141

by Brassica Pharma Pvt Ltd

Reason
Lack of Assurance of Sterility
Recall initiated
January 30, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-028-35, UPC 681131395304

by Brassica Pharma Pvt Ltd

Reason
Lack of Assurance of Sterility
Recall initiated
January 30, 2024
Reported by FDA
March 6, 2024
Distribution
Nationwide within the United States

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.