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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 9,301–9,320 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL, packaged in a) 5 mL and b) 10 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

by Ranier's Compounding Laboratory

Reason
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Recall initiated
July 25, 2018
Reported by FDA
August 22, 2018
Distribution
Product was distributed within the state of Pennsylvania.

View recall →

Drug Recall Terminated Historical recordClass II

Avastin 1.25 mg/0.05 mL prefilled syringe, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

by Ranier's Compounding Laboratory

Reason
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Recall initiated
July 25, 2018
Reported by FDA
August 22, 2018
Distribution
Product was distributed within the state of Pennsylvania.

View recall →

Drug Recall Terminated Historical recordClass II

DMSO 6.25% Opth Sol, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

by Ranier's Compounding Laboratory

Reason
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Recall initiated
July 25, 2018
Reported by FDA
August 22, 2018
Distribution
Product was distributed within the state of Pennsylvania.

View recall →

Drug Recall Terminated Historical recordClass II

Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.

by Ranier's Compounding Laboratory

Reason
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Recall initiated
July 25, 2018
Reported by FDA
August 22, 2018
Distribution
Product was distributed within the state of Pennsylvania.

View recall →

Drug Recall Terminated Historical recordClass III

Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
Recall initiated
August 2, 2018
Reported by FDA
August 22, 2018
Distribution
U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass II

alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g 3 oz tube. Manufactured by: The Haine Celestial Group, Inc. Lake Success, NY, UPC 7 24742 00438 5

by The Hain Celestial Group, Inc. - Worldwide HQ

Reason
Microbial Contamination of a Non-Sterile Product
Recall initiated
July 25, 2018
Reported by FDA
August 22, 2018
Distribution
Product was distributed to one distributor in California who may have distributed the product further within the US.

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Drug Recall Terminated Historical recordClass II

Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03

by Lupin Pharmaceuticals Inc.

Reason
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Recall initiated
August 13, 2018
Reported by FDA
August 22, 2018
Distribution
Product was distributed to distributors, mail order pharmacy and supermarkets throughout the United States.

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Drug Recall Terminated Historical recordClass III

Acne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Distributed by: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320, NDC 71537-001-02

by Huijing (Shanghai) Bio-tech Co., Ltd.

Reason
Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.
Recall initiated
August 3, 2018
Reported by FDA
August 22, 2018
Distribution
Product was distributed to one distributor in VA

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Drug Recall Terminated Historical recordClass I

Blissful Remedies Gold Series Ultra Enhanced Indo, 50 capsule, packaged in While Foil Pouch, Dist. by World Organix LLC, Las Vegas Nevada UPC# 6 02401 88900 2

by World Organix, LLC

Reason
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Recall initiated
June 26, 2018
Reported by FDA
August 15, 2018
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

Magnesium Sulfate 200 mg/mL, 100ml. Rx. Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC 6910-3218-07) and b) 8 Fl OZ (NDC 6910-3218-08) bottles, 77656 Flora Rd, Palm Desert, CA 92211.

by Longbow First Aid Products Manufactory

Reason
CGMP Deviations
Recall initiated
July 17, 2018
Reported by FDA
August 15, 2018
Distribution
NY and CA.

View recall →

Drug Recall Terminated Historical recordClass II

Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (118 ml) NDC 7110500002, and b) 0.67 fl (20 ml) NDC 71150000) bottles, Manufactured for: Redicare LLC, Congers, NY

by Longbow First Aid Products Manufactory

Reason
CGMP Deviations
Recall initiated
July 17, 2018
Reported by FDA
August 15, 2018
Distribution
NY and CA.

View recall →

Drug Recall Terminated Historical recordClass II

Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,

by NuCare Pharmaceuticals Inc

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 30, 2018
Reported by FDA
August 15, 2018
Distribution
Distributed to three customers in Fl and CA

View recall →

Drug Recall Terminated Historical recordClass I

Blissful Remedies Kratom+CBD CBD infused Maeng Da, capsules 50-count packaged in While Foil Pouch. Dist. by World Organix LLC, Las Vegas Nevada UPC# 7 11583 27057 4

by World Organix, LLC

Reason
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Recall initiated
June 26, 2018
Reported by FDA
August 15, 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.