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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 9,201–9,220 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass I

Thyroveev, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-025-02

by Hellolife

Reason
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Recall initiated
August 23, 2018
Reported by FDA
September 19, 2018
Distribution
Nationwide USA, Algeria Australia Belgium Brazil Bulgaria Canada Colombia Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Estonia French Polynesia Greece Guadeloupe Guam Hong Kong Hungary India Ireland Israel Italy Latvia Lithuania Martinique Mexico Monaco Netherlands New Zealand Norway Peru Poland Portugal Romania Russia Russian Federation Saudi Arabia Senegal Serbia Slovakia Slovakia (Slovak Republic) Slovenia Swaziland Sweden Swit

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Drug Recall Terminated Historical recordClass I

Neuroveen, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-015-02

by Hellolife

Reason
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Recall initiated
August 23, 2018
Reported by FDA
September 19, 2018
Distribution
Nationwide USA, Algeria Australia Belgium Brazil Bulgaria Canada Colombia Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Estonia French Polynesia Greece Guadeloupe Guam Hong Kong Hungary India Ireland Israel Italy Latvia Lithuania Martinique Mexico Monaco Netherlands New Zealand Norway Peru Poland Portugal Romania Russia Russian Federation Saudi Arabia Senegal Serbia Slovakia Slovakia (Slovak Republic) Slovenia Swaziland Sweden Swit

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Drug Recall Terminated Historical recordClass I

Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-034-02

by Hellolife

Reason
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Recall initiated
August 23, 2018
Reported by FDA
September 19, 2018
Distribution
Nationwide USA, Algeria Australia Belgium Brazil Bulgaria Canada Colombia Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Estonia French Polynesia Greece Guadeloupe Guam Hong Kong Hungary India Ireland Israel Italy Latvia Lithuania Martinique Mexico Monaco Netherlands New Zealand Norway Peru Poland Portugal Romania Russia Russian Federation Saudi Arabia Senegal Serbia Slovakia Slovakia (Slovak Republic) Slovenia Swaziland Sweden Swit

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Drug Recall Terminated Historical recordClass I

Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205, 877.550.5059, barcode 70004063032.

by SCA Pharmaceuticals, Inc.

Reason
Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Recall initiated
August 27, 2018
Reported by FDA
September 19, 2018
Distribution
Three hospitals in DC, VA, CT

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Drug Recall Terminated Historical recordClass III

Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) (NDC 66302-206-01) b) TD-300/A Replacement Device Kit Material Number RTP3099 RX Only. Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709

by United Therapeutics Corp.

Reason
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Recall initiated
August 14, 2018
Reported by FDA
September 19, 2018
Distribution
IL, PA

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Drug Recall Terminated Historical recordClass III

Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05

by Mylan Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Recall initiated
August 7, 2018
Reported by FDA
September 19, 2018
Distribution
Distributed Nationwide in the US

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Drug Recall Terminated Historical recordClass III

Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01

by Mylan Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Recall initiated
August 7, 2018
Reported by FDA
September 19, 2018
Distribution
Distributed Nationwide in the US

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Drug Recall Terminated Historical recordClass III

Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11

by Par Pharmaceutical, Inc.

Reason
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Recall initiated
September 6, 2018
Reported by FDA
September 19, 2018
Distribution
United States nationwide

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Drug Recall Terminated Historical recordClass III

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01

by Pfizer Inc.

Reason
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Recall initiated
August 28, 2018
Reported by FDA
September 19, 2018
Distribution
Nationwide USA

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Drug Recall Terminated Historical recordClass II

Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss Caps AG, Kirchberg, Switzerland. NDC: 61748-025-01

by Akorn, Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
Recall initiated
August 24, 2018
Reported by FDA
September 12, 2018
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-888-90

by Avkare Incorporated

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 18, 2018
Reported by FDA
September 12, 2018
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90

by Avkare Incorporated

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 18, 2018
Reported by FDA
September 12, 2018
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-887-90

by Avkare Incorporated

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 18, 2018
Reported by FDA
September 12, 2018
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-885-90

by Avkare Incorporated

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 18, 2018
Reported by FDA
September 12, 2018
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90

by Avkare Incorporated

Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated
July 18, 2018
Reported by FDA
September 12, 2018
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in boxes of 20 cups), Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977 Dist. By: McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51

by MCKESSON CORPORATION

Reason
Supterpotent Drug
Recall initiated
August 14, 2018
Reported by FDA
September 12, 2018
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass III

Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15

by Validus Pharmaceuticals, Inc.

Reason
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Recall initiated
June 15, 2018
Reported by FDA
September 5, 2018
Distribution
U.S. nationwide

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Drug Recall Terminated Historical recordClass III

Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59

by Validus Pharmaceuticals, Inc.

Reason
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Recall initiated
June 15, 2018
Reported by FDA
September 5, 2018
Distribution
U.S. nationwide

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Drug Recall Terminated Historical recordClass II

Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 07940 USA, NDC 0573-0207-30, UPC 3-0573-0207-30-0

by Pfizer Global Supply

Reason
Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
Recall initiated
August 23, 2018
Reported by FDA
September 5, 2018
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass III

Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10

by Akorn, Inc.

Reason
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Recall initiated
August 8, 2018
Reported by FDA
September 5, 2018
Distribution
Nationwide USA

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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.