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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 8,021–8,040 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

HCG 23 Day, 2876 Units/4.6 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

HCG 20 Day Injection, 2625 Units/4 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

HCG 11,000 Units, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

HCG 1,000 U/mL Injection, 30 mL, Vial Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Gentamicin 250 mg/1000 mL Irrigation, 1000 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Gentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol Cypionate 10 mg/mL, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

DMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41 mL syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dexamethasone 24 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy, 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin 125 mg/3mL Inhalation, 3 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Amphotericin B 0.15% Eye Drops, 2 mL Droppers, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Atropine 0.01% Eye Drops, 1 mL and 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.

by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
April 2, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8.

by Iso-Tex Diagnostics, Inc

Reason
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Recall initiated
April 15, 2019
Reported by FDA
April 24, 2019
Distribution
TN

View recall →

Drug Recall Terminated Historical recordClass II

Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA

by Dr. Reddy's Laboratories, Inc.

Reason
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Recall initiated
April 11, 2019
Reported by FDA
April 24, 2019
Distribution
Product was distributed to major distributors and retailers who may have further distribute the product throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass III

Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15, packaged in a light green folding carton containing a 50 mL silver jar with a silver cap, Clinique Laboratories, Dist. New York, NY 10022

by Estee Lauder Inc

Reason
Defective container: Ineffective seal between the cap and jar of the affected product.
Recall initiated
March 15, 2019
Reported by FDA
April 24, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's Whole Heallth Products, 400 Hillsboro Technology Drive, Deerfield BEach, FL 33441 SKU#182 UPC 00854582001036

by MSM Nutraceuticals, LLC

Reason
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Recall initiated
March 12, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Naphazolene Chloride, Net Wt. 15ml, 0.15 fl oz., Manufactured by: MSM Nutraceuticals, LLC , UPC 8 54582 00118 0

by MSM Nutraceuticals, LLC

Reason
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Recall initiated
March 12, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Polyethylene Glycon, Net Wt. 15ml, 0.51 fl oz., Manufactured by: MSM Nutraceuticals, LLC, UPC 8 54582 00119 7.

by MSM Nutraceuticals, LLC

Reason
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Recall initiated
March 12, 2019
Reported by FDA
April 24, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceuticals, LLC 2103 West Parkside Lane, Ste.107, Phoenix, AZ 85027, UPC 8 54582 00120 3.

by MSM Nutraceuticals, LLC

Reason
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Recall initiated
March 12, 2019
Reported by FDA
April 24, 2019
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.