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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 9,081–9,100 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875519155

by Valeant Pharmaceuticals North America LLC

Reason
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Recall initiated
August 24, 2018
Reported by FDA
October 31, 2018
Distribution
Product was distributed throughout the United States

View recall →

Drug Recall Terminated Historical recordClass II

Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875521011

by Valeant Pharmaceuticals North America LLC

Reason
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Recall initiated
August 24, 2018
Reported by FDA
October 31, 2018
Distribution
Product was distributed throughout the United States

View recall →

Drug Recall Terminated Historical recordClass II

Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875518028

by Valeant Pharmaceuticals North America LLC

Reason
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Recall initiated
August 24, 2018
Reported by FDA
October 31, 2018
Distribution
Product was distributed throughout the United States

View recall →

Drug Recall Terminated Historical recordClass II

HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA 19154, NDC 54838-502-80.

by Lannett Company, Inc.

Reason
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Recall initiated
October 11, 2018
Reported by FDA
October 31, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CVS Health, Original Strength, Triple Antibiotic Ointment Spray (bacitracin zinc 400 units, neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units per gram), 2 OZ (57 g) can, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Product#957603, UPC 0 50428 29525 0.

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

Well at Walgreens, ULTRA FINE Sinus Relief Mist (Oxymetazoline HCl 0.05%) bottle, Sinus Reliever, Nasal Decongestant, 12 Hour Pump Mist, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7000-01, UPC 3 11917 18535 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

Best Choice, SALINE Nasal Spray (Sodium Chloride 0.65% Phenylcarbinol & Benzalkonium Chloride as Preservatives), 1.5 FL OZ (44 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 58487 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 →

Drug Recall Terminated Historical recordClass II

Best Choice, 12 Hour No-Drip 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 59895 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

Rite Aid Pharmacy, nasal relief NO DRIP PUMP SPRAY nasal spray, (oxymetazoline hydrochloride 0.05%), 12 Hour, 1 FL OZ (30 mL) bottle, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 31412 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

Premier Value, Sterile Saline Nasal Mist, Saline Nasal Moisturizer (0.9% Sodium Chloride) Solution, 4.25 FL OZ (126 mL) can, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 8 40986 02998 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

Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray (Oxymetazoline HCl 0.05%), 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-304-03, UPC 8 40986 01518 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 →

Drug Recall Terminated Historical recordClass II

Harmon Face Values, Saline Nasal Gel with Soothing Aloe, 0.5 oz. (14.1 g) tube, Distributed by: Harmon Stores, Inc., Union, NJ 07083 USA, UPC 7 27510 00474 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

CVS Health, Saline Nasal Spray, 1.5 FL OZ bottle, Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, Product #277790.

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

CareOne, Saline Nasal Gel With Soothing Aloe, Net Wt. 0.5 OZ (14.1 g) tube, Distributed by Foodhold U.S.A., LLC., Landover, MD 20785, 1-877-846-9949, UPC 3 41520 00175 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

Rhinall (phenylephrine hydrochloride) Nasal Decongestant Nose Drops, 0.25%, 1 FL OZ (30 mL) bottle, Distributed by: Scherer Labs International, LLC., 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02747 52531 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 III

Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.

by Amerigen Pharmaceuticals Inc.

Reason
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Recall initiated
October 5, 2018
Reported by FDA
October 24, 2018
Distribution
Product was distributed U.S. nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96

by Teva Pharmaceuticals USA

Reason
Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
Recall initiated
September 20, 2018
Reported by FDA
October 24, 2018
Distribution
Product was distributed throughout the United States to various distributors who may have further distributed the product.

View recall →

Drug Recall Terminated Historical recordClass II

Family Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562.

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

Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By: Efficient Laboratories, Inc., Miami, FL 33166.

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, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48 pk. (12687901)

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.