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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 3,401–3,420 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass I

Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6839-73

by Plastikon Healthcare LLC

Reason
Microbial Contamination of Non-Sterile Products.
Recall initiated
June 7, 2022
Reported by FDA
September 14, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73

by Plastikon Healthcare LLC

Reason
Microbial Contamination of Non-Sterile Products.
Recall initiated
June 7, 2022
Reported by FDA
September 14, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6840-72.

by Plastikon Healthcare LLC

Reason
Microbial Contamination of Non-Sterile Products.
Recall initiated
June 7, 2022
Reported by FDA
September 14, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6846-73.

by Plastikon Healthcare LLC

Reason
Microbial Contamination of Non-Sterile Products
Recall initiated
June 7, 2022
Reported by FDA
September 14, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36.

by Padagis US LLC

Reason
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Recall initiated
August 17, 2022
Reported by FDA
September 7, 2022
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ. (1 PT) 355 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965765.

by Tsm Brands LLC

Reason
Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Recall initiated
July 19, 2022
Reported by FDA
September 7, 2022
Distribution
Distributed in VA, USA

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Drug Recall Ongoing Historical recordClass II

Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.

by Tsm Brands LLC

Reason
Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Recall initiated
July 19, 2022
Reported by FDA
September 7, 2022
Distribution
Distributed in VA, USA

View recall →

Drug Recall Terminated Historical recordClass II

Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01

by Teva Pharmaceuticals USA Inc

Reason
CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
Recall initiated
August 23, 2022
Reported by FDA
September 7, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4.

by LNK International, Inc.

Reason
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Recall initiated
August 4, 2022
Reported by FDA
September 7, 2022
Distribution
Product was distributed to one retailer who may have further distributed the product to other distribution sites nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass III

Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24

by Akorn, Inc

Reason
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Recall initiated
August 8, 2022
Reported by FDA
September 7, 2022
Distribution
Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 473 mL UPC 0 35000 67111 0. Dist. by: Colgate-Palmolive Co. New York, NY 10022 U.S.A.

by Family Dollar Stores, Llc.

Reason
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Recall initiated
August 10, 2022
Reported by FDA
September 7, 2022
Distribution
Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT

View recall →

Drug Recall Ongoing Historical recordClass II

Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT PASTE. Net Wt. 4.2 OZ. (119 g) UPC 0 35000 45836 0. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.

by Family Dollar Stores, Llc.

Reason
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Recall initiated
August 10, 2022
Reported by FDA
September 7, 2022
Distribution
Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT

View recall →

Drug Recall Ongoing Historical recordClass II

Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT PASTE, Net Wt. 4.2 OZ. UPC 0 35000 97872 1. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.

by Family Dollar Stores, Llc.

Reason
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Recall initiated
August 10, 2022
Reported by FDA
September 7, 2022
Distribution
Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT

View recall →

Drug Recall Ongoing Historical recordClass II

Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH, Net Wt. 3.2 OZ. (90 g) UPC 0 35000 97159 3. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.

by Family Dollar Stores, Llc.

Reason
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Recall initiated
August 10, 2022
Reported by FDA
September 7, 2022
Distribution
Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT

View recall →

Drug Recall Ongoing Historical recordClass II

Colgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Peroxide, High Impact White, Net Wt. 3.0 OZ. (85 g) UPC 0 35000 97008 4. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.

by Family Dollar Stores, Llc.

Reason
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Recall initiated
August 10, 2022
Reported by FDA
September 7, 2022
Distribution
Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT

View recall →

Drug Recall Ongoing Historical recordClass II

Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevention, 5% Hydrogen Peroxide, Net Wt. 2.1 OZ. (59 g) UPC 0 35000 99658 9. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.

by Family Dollar Stores, Llc.

Reason
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Recall initiated
August 10, 2022
Reported by FDA
September 7, 2022
Distribution
Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT

View recall →

Drug Recall Ongoing Historical recordClass II

MUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

MUCINEX FASTMAX CAPLETS COLD FLU 4CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

REFENESEN MUCUS RELIEF TABLET 30 CT SKU 917531 MUCINEX DM MAX STRENGTH 7CT SKU 900854 RIC MUCUS RLF DM MAX STNGTH CHRY 6FL OZ SKU 999559 VICKS JARABE COUGH CONGESTION 8FLOZ SKU 998933 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

MYLICON INFANT GAS DROPS 0.5 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

by Family Dollar Stores, Llc.

Reason
CGMP Deviations: product held outside appropriate storage temperature conditions.
Recall initiated
June 23, 2022
Reported by FDA
August 31, 2022
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.