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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 9,121–9,140 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slippery Elm, 1.5 FL OZ (44 mL) bottle, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00660 4.

by Product Quest Manufacturing LLC

Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Thayers Natural Remedies, Saline Nasal Mist, Allergy & Sinus Relief, Slippery Elm, 3 FL OZ (89 mL) can, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00659 8.

by Product Quest Manufacturing LLC

Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

QC Quality Choice, Saline Nasal Relief, Moisturizing Nasal Spray, Sodium Chloride 0.65%, packaged as a) 1.5 FL OZ (45 mL) bottle UPC 6 35515 98845 3; b) 3 FL OZ (89 mL) bottle UPC 6 35515 95042 9, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995.

by Product Quest Manufacturing LLC

Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

QC Quality Choice, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14.1 g) tube, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, UPC 6 35515 99202 3.

by Product Quest Manufacturing LLC

Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL) bottle NDC 68016-388-00 UPC 8 40986 01483 3; b) 1.5 FL OZ (44 mL) bottle NDC 68016-466-00 UPC 8 40986 01482 6, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431.

by Product Quest Manufacturing LLC

Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Premier Value, Nasal Decongestant, Nasal Spray (oxymetazoline HCl 0.05%), Regular Strength, 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-316-03, UPC 8 40986 01516 8.

by Product Quest Manufacturing LLC

Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Premier Value, Nasal Decongestant, No Drip Nasal Spray (oxymetazoline HCl) Nasal Solution, 12 Hour Pump Mist, Maximum Strength, 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-308-03, UPC 8 40986 01519 9.

by Product Quest Manufacturing LLC

Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer Labs International, LLC. 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02742 68045 9 .

by Product Quest Manufacturing LLC

Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Meijer, Sterile Saline Nasal Mist (0.9% Sodium Chloride Solution), 4.25 OZ (120 g) can, Dist. By Meijer Distribution, Inc., 2929 Walker Ave. NW, Grand Rapids, MI 49544, UPC 7 13733 27615 3.

by Product Quest Manufacturing LLC

Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

meijer, Saline Nasal Spray, Nasal Moisturizing Spray, packaged as a) 1.5 FL OZ (44 mL) UPC 7 08820 74428 8; b) 3FL OZ (88 mL) UPC 7 08820 74430 1, Dist. By Meijer Distribution, Inc., Grand Rapids, MI 49544 .

by Product Quest Manufacturing LLC

Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Harmon Face Values, Saline Nasal Spray (sodium chloride), 0.65%, packaged as a) 1.5 FL OZ (44 mL) bottle UPC 7 27510 00501 0; b) 3 FL OZ (88 mL) bottle UPC 7 27510 00502 7, Distributed by Harmon Stores, Inc., Union, NJ 07083 USA.

by Product Quest Manufacturing LLC

Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium Chloride Solution), 4.25 FL OZ (126 mL) can, Distributed by: Midwood Brands, LLC, 10611 Monroe Rd., Matthews, NC 28105, UPC 0 32251 11617 9.

by Product Quest Manufacturing LLC

Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

DG health, No Drip, Nasal Pump Mist (oxymetazoline hydrochloride), 0.05%, 1 FL OZ (30 mL) bottle, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072, UPC 7 27510 00373 3 .

by Product Quest Manufacturing LLC

Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Discount Drug Mart, Food Fair, Saline Nasal Spray (sodium chloride) 0.65%, packaged as a) 3 FL OZ (89 mL) bottle UPC 0 93351 01833 6; b) 1.5 FL OZ (45 mL) bottle UPC 0 93351 01834 3, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256

by Product Quest Manufacturing LLC

Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CVS Health, Saline Nasal Gel with Soothing Aloe, packaged as a) Baby Net Wt. 0.5 OZ (14.2 g) tube UPC 0 50428 58392 0 Product #282476; and b) Net Wt. 0.5 OZ tube (14.2 g) UPC 0 50428 31746 4 Product #896071; Distributed by CVS Pharmacy, Inc,. One CVS Drive, Woonsocket, RI 02895.

by Product Quest Manufacturing LLC

Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CVS Health, Baby Nasal Spray/Drops, Non-Medicated, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 29380 5 Product #459367.

by Product Quest Manufacturing LLC

Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, 3.0%, 4.25 OZ (126 g) can, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 41854 3.

by Product Quest Manufacturing LLC

Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CVS Health, Saline Nasal Spray, Nasal Moisturizing Spray, Contains: Sodium Chloride 0.65%, Benzyl Alcohol & Benzalkonium Chloride as Preservatives, 1.5 FL OZ (44 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 40814 8 Product #891465.

by Product Quest Manufacturing LLC

Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9%, packaged in a) Net Wt. 1.52 OZ (43 g) can UPC 0 50428 37079 7 Product #896831; b) Net Wt. 4.25 OZ (120 g) can UPC 0 50428 36124 5; c) Children's Net Wt. 2 OZ (57 g) can UPC 0 50428 58685 3 Product #282472, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.

by Product Quest Manufacturing LLC

Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, SPF 50, Net Wt. 0.49 oz. (13.9g) stick, Distributed by: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 0 20908 05100 3.

by Product Quest Manufacturing LLC

Reason
Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
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.