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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 7,681–7,700 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63788-120-04.

by Pharma-Natural Inc.

Reason
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recall initiated
June 21, 2019
Reported by FDA
July 31, 2019
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment, Pkg Size 3 g Tube, Generic for: Maxitrol, For External Use Only, Rx only, Mfg: Paddock Laboratories, LLC, Preferred Pharmaceuticals, Inc., The Physicians Solutions, Anaheim, CA, NDC 68788-9373-03.

by Preferred Pharmaceuticals, Inc

Reason
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Recall initiated
July 18, 2019
Reported by FDA
July 31, 2019
Distribution
CA, FL

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Drug Recall Terminated Historical recordClass III

Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01.

by Lupin Pharmaceuticals Inc.

Reason
Labeling: Missing label; Product complaints reported missing bottle label.
Recall initiated
July 11, 2019
Reported by FDA
July 24, 2019
Distribution
Nationwide in the U.S. and PR.

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Drug Recall Terminated Historical recordClass I

Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand]

by Fresenius Kabi USA, LLC

Reason
Presence of Particulate Matter; glass particulates
Recall initiated
June 28, 2019
Reported by FDA
July 24, 2019
Distribution
Nationwide USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-23, Barcode (01)00304092776233.

by Pfizer Inc.

Reason
Lack of Assurance of Sterility: Bags have the potential to leak.
Recall initiated
July 9, 2019
Reported by FDA
July 24, 2019
Distribution
United States, PR, and Guam

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Drug Recall Terminated Historical recordClass II

Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-02, Barcode (01)00304092776028.

by Pfizer Inc.

Reason
Lack of Assurance of Sterility: Bags have the potential to leak.
Recall initiated
July 9, 2019
Reported by FDA
July 24, 2019
Distribution
United States, PR, and Guam

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Drug Recall Terminated Historical recordClass II

Serum Tears 20% Eye Drops PF Solution, packaged in a) 15 EA, b)15 mL vials, c) 12 EA, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343- 6252

by First Pharma Associates LLC dba Riverpoint Pharmacy

Reason
Lack of Assurance of Sterility.
Recall initiated
June 26, 2019
Reported by FDA
July 17, 2019
Distribution
ID, WA only

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Drug Recall Terminated Historical recordClass II

Glutathione 100 mg/mL Inhalation Solution (PF), 45 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252

by First Pharma Associates LLC dba Riverpoint Pharmacy

Reason
Lack of Assurance of Sterility.
Recall initiated
June 26, 2019
Reported by FDA
July 17, 2019
Distribution
ID, WA only

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Drug Recall Terminated Historical recordClass II

Chorionic Gonadotropin 2,000U/mL PF Injection, 8 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252

by First Pharma Associates LLC dba Riverpoint Pharmacy

Reason
Lack of Assurance of Sterility.
Recall initiated
June 26, 2019
Reported by FDA
July 17, 2019
Distribution
ID, WA only

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Drug Recall Terminated Historical recordClass II

PAP/PHEN/PGE1 18 mg/0.6mg/5.88mcg/mL Injection, 5 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252

by First Pharma Associates LLC dba Riverpoint Pharmacy

Reason
Lack of Assurance of Sterility.
Recall initiated
June 26, 2019
Reported by FDA
July 17, 2019
Distribution
ID, WA only

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Drug Recall Terminated Historical recordClass II

PAP/PHEN/PGE1 30 mg/0.83mg/10mcg/mL Injection, 5 mL, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252

by First Pharma Associates LLC dba Riverpoint Pharmacy

Reason
Lack of Assurance of Sterility.
Recall initiated
June 26, 2019
Reported by FDA
July 17, 2019
Distribution
ID, WA only

View recall →

Drug Recall Terminated Historical recordClass II

PAP/PHEN/PGE1 30 mg/2mg/20mcg/mL Injection, 10mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252

by First Pharma Associates LLC dba Riverpoint Pharmacy

Reason
Lack of Assurance of Sterility.
Recall initiated
June 26, 2019
Reported by FDA
July 17, 2019
Distribution
ID, WA only

View recall →

Drug Recall Terminated Historical recordClass II

PAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection, 5mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252

by First Pharma Associates LLC dba Riverpoint Pharmacy

Reason
Lack of Assurance of Sterility.
Recall initiated
June 26, 2019
Reported by FDA
July 17, 2019
Distribution
ID, WA only

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Drug Recall Terminated Historical recordClass II

Methylcobalamin 10 mg/mL Injection, 5.4 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.

by First Pharma Associates LLC dba Riverpoint Pharmacy

Reason
Lack of Assurance of Sterility.
Recall initiated
June 26, 2019
Reported by FDA
July 17, 2019
Distribution
ID, WA only

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin 1 mg/mL Injection, 8 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252

by First Pharma Associates LLC dba Riverpoint Pharmacy

Reason
Lack of Assurance of Sterility.
Recall initiated
June 26, 2019
Reported by FDA
July 17, 2019
Distribution
ID, WA only

View recall →

Drug Recall Terminated Historical recordClass II

Hydroxocobalamin 10 mg/mL Injection (ALT) Solution, 30 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252

by First Pharma Associates LLC dba Riverpoint Pharmacy

Reason
Lack of Assurance of Sterility.
Recall initiated
June 26, 2019
Reported by FDA
July 17, 2019
Distribution
ID, WA only

View recall →

Drug Recall Terminated Historical recordClass II

Prostaglandin 20 mcg/mL/Procaine 0.1% Injection, packaged in a) 2.5mL and b)10 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205 (509) 343-6252

by First Pharma Associates LLC dba Riverpoint Pharmacy

Reason
Lack of Assurance of Sterility.
Recall initiated
June 26, 2019
Reported by FDA
July 17, 2019
Distribution
ID, WA only

View recall →

Drug Recall Terminated Historical recordClass II

Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection, 5 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252

by First Pharma Associates LLC dba Riverpoint Pharmacy

Reason
Lack of Assurance of Sterility.
Recall initiated
June 26, 2019
Reported by FDA
July 17, 2019
Distribution
ID, WA only

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/mL Injection, 3mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.

by First Pharma Associates LLC dba Riverpoint Pharmacy

Reason
Lack of Assurance of Sterility.
Recall initiated
June 26, 2019
Reported by FDA
July 17, 2019
Distribution
ID, WA only

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate 100 mg/mLOil Injection Injection, 12 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.

by First Pharma Associates LLC dba Riverpoint Pharmacy

Reason
Lack of Assurance of Sterility.
Recall initiated
June 26, 2019
Reported by FDA
July 17, 2019
Distribution
ID, WA only

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.