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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 11,021–11,040 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

FLUOCINONIDE 0.05% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Recall initiated
February 10, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

FLUORORACIL 0.05% CREAM, FLUORORACIL 5% CREAM, FLUOROURACIL 4.9% IN CERAVE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Recall initiated
February 10, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

ERYTHROMYCIN 2% IN CERAVE CREAM, ERYTHROMYCIN 3% / RETINOIC ACID 0.05%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Recall initiated
February 10, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

CLOBETASOL 0.05% IN OLEA BASE, CLOBETASOL 0.05% IN OROBASE, CLOBETASOL 0.05% OINTMENT, CLOBETASOL 0.05%/ SODIUM, SULFACETAMIDE 10% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Recall initiated
February 10, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

CLINDAMYCIN 1%, AZELAIC ACID 10% CREAM, CLINDAMYCIN 1.2%/ TRETINOIN 0.05% GEL, CLINDAMYCIN 1.2%/ TRETINOIN 0.1% GEL CLINDAMYCIN 2.5%, BENZOYL PEROXIDE 5%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Recall initiated
February 10, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

BLEACHING CREAM 0.1% CREAM, BLEACHING CREAM HQ4%, BLEACHING CREAM-NO HQ, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Recall initiated
February 10, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

BL 20%/4% CREAM, BLT 20%/6%/4% CREAM, BLT 20%/6%/6%, BLT 20% 8% 4% CREAM, BLT 20% 8% 4% OINTMENT, BLT 20% 8% 6% CREAM, BLT 20%/ 8% /8% OINTMENT, BLT 20%/ 8% /8% CREAM, BLT 20%/ 7%/ 7% CREAM, BLT 20%/ 10%/ 4% CREAM, BLT 20%/ 10%/ 10% CREAM, BLT 20%/ 20%/ 10% OINTMENT,BLT 7%/ 10%/ 7% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Recall initiated
February 10, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

BENZOYL PEROXIDE 5% CLINDAMYCIN 1.2%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Recall initiated
February 10, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

ADAPALENE 0.1%, BENZOYL PEROXIDE 2.5% GEL, ADAPELENE 0.3%, BENZOYL PEROXIDE 2,5% GEL, AZELAIC ACID 15% CREAM, AZELAIC ACID 20% IN OI FREE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Recall initiated
February 10, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

BICARBONATE 10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Recall initiated
February 10, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

MINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.025, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Recall initiated
February 10, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

5-FLUOROURACIL IN VANICREAM, FLUOROURACIL in all strengths including 0.05%, 5% CREAM, FLUOROURACIL 4.9% IN CERAVE CREAM, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Recall initiated
February 10, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%, Rx only, Synergy Rx, 4901 Morena Blvd #504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Recall initiated
February 10, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

KETOCONAZOLE 2%/HYDROCORTISONE 1.5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676.

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Recall initiated
February 10, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

HCG and HCG with resveratrol Human Chorionic Gonadotropin in different strengths: HCG 300 UNITS/RESVERATROL 50MG S.L. Tablet, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Recall initiated
February 10, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

CANTHARADIN 0.7% SOLUTION and CANTHARIDAN / PODOPHYLLUM SOLUTION, CANTHARIDIN/PODOPHYLLUM RESIN MIXTURE, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Recall initiated
February 10, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676

by Synergy Rx

Reason
Lack of Assurance of Sterility: There are also CGMP Deviations.
Recall initiated
February 10, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TOOTHPASTE, SLS Free Formula, SOOTHING MINT, 3.4 FL OZ (100 mL), Colgate Oral Pharmaceuticals, Inc., New York, NY 10022 --- NDC 0126-0016-61, UPC 3834110622

by Colgate Palmolive Co

Reason
Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Recall initiated
February 13, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21

by Amerisource Health Services

Reason
Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Recall initiated
February 3, 2017
Reported by FDA
March 22, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL applicator bottles (NDC 0472-0987-92), Rx Only, Manufactured by: G&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080; Distributed by: Actavis Mid Atlantic LLC, 1877 Kawai Road, Lincolnton, NC 28092.

by G & W Laboratories, Inc.

Reason
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Recall initiated
February 28, 2017
Reported by FDA
March 22, 2017
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.