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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 9,101–9,120 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48/3/1 #12687901 w/ Silo

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

Rexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%), 1 FL OZ (30mL) bottle, SKU 00744201

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

Rhinall Nasal Decongestant Nasal Spray (phenylephrine HCl), 0.25%, 1 1/3 Fl Oz. (40 ml), Manufactured for: Scherer Laboratories, Inc., Atlanta, GA 30339.

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 I

Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 43236 5.

by Product Quest Manufacturing LLC

Reason
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Mushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8%, 8 oz. (226 g) tube, Distributed by Mushatts, LLC, P.O. Box 372476, Satellite Beach, FL 32937, UPC 8 58245 00203 3.

by Product Quest Manufacturing LLC

Reason
Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding specification and low out of specification assay results for salicylic acid.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%, octisalate 5%, octocrylene 10%, Net Wt. 0.15 oz. (4.25 g) stick, CeraVe LLC., New York, NY 10001, UPC 3 01872 49201 7.

by Product Quest Manufacturing LLC

Reason
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone 6%), 0.7 oz. (19.8 g) tube, Distributed by: Genomma Lab USA Inc., Houston, TX 77027, UPC 6 50067 00018 7.

by Product Quest Manufacturing LLC

Reason
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tube, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, UPC 3 11917 18281 0.

by Product Quest Manufacturing LLC

Reason
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
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, Fast Relief, Muscle Rub, (menthol 10% and methyl salicylate 15%) 4 OZ (113 g) tube, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd., Suite 101, Boca Raton, FL, 33431, UPC 8 40986 01341

by Product Quest Manufacturing LLC

Reason
Superpotent Drug: high out of specification assay results for the menthol ingredient.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Rite Aid Pharmacy, First Aid Antibiotic Ointment, (neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units, bacitracin zinc 400 units per gram), 2 OZ (56 g) tube, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 55441 1.

by Product Quest Manufacturing LLC

Reason
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

FREEZE IT (camphor 0.2% and menthol 3.5%) spray, 118.29 mL (4 fl. oz.) can, Distributed by: Expedite Products, Inc., Tampa, FL 33619 USA, UPC 8 56569 00203 6.

by Product Quest Manufacturing LLC

Reason
Superpotent Drug: high out of specification assay results for the camphor ingredient.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

dr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube, Distributed by: Cosmetic Dermatology, Inc., Miami, FL 33172, UPC 6 63963 00828 7.

by Product Quest Manufacturing LLC

Reason
Failed Stability Specifications: separation of product and failure for actives.
Recall initiated
August 3, 2018
Reported by FDA
October 24, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour + Menthol, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7001-01, UPC 3 11917 18536 1.

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

Walgreens, NO DRIP, Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Original, 12 Hour, Maximum Strength, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015,NDC 0363-7005-01, UPC 3 11917 18537 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

Walgreens, NO DRIP Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Extra Moisturizing, 12 Hour, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7004-01, UPC 3 11917 18534 7.

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

Walgreens, Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour, 0.75 FL OZ (22 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, UPC 3 11917 18622 1.

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

Best Choice, 12 Hour Sinus Relief, Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co,. 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 63684 7.

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

Best Choice, 12 Hour Extra Moisturizing, Nasal Spray (Oxymetazoline Hydrochloride 0.05%), Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave., Kansas City, KS 66106, UPC 0 70038 59328 7.

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

OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9; b) 45 cc (1.5 fl. oz.) UPC 3 01875 26003 3, c) Buddy Pack containing one 1.5 FL. OZ. (44 mL) and one 0.76 FL.OZ. (22 mL) bottle per carton, Distributed by: Valeant Consumer Products, A Division of Valeant Pharmaceuticals, North America LLC, Bridgewater, NJ 08807.

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

TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed By Topco Associates LLC, Elk Grove Village, IL 60007, UPC 0 36800 42146 2.

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 →

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.