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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 8,101–8,120 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass III

Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017. NDC 0009-3447-01

by Pfizer Inc.

Reason
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Recall initiated
March 15, 2019
Reported by FDA
April 10, 2019
Distribution
Nationwide USA and Guam

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Drug Recall Terminated Historical recordClass III

Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-3124-01

by Pfizer Inc.

Reason
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Recall initiated
March 15, 2019
Reported by FDA
April 10, 2019
Distribution
Nationwide USA and Guam

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Drug Recall Terminated Historical recordClass III

Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-6582-02

by Pfizer Inc.

Reason
Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
Recall initiated
March 15, 2019
Reported by FDA
April 10, 2019
Distribution
Nationwide USA and Guam

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Drug Recall Terminated Historical recordClass I

Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riverside, CA 92507, UPC 7 48252 66460 0

by Ata International Inc

Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.
Recall initiated
March 14, 2019
Reported by FDA
April 3, 2019
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-502-49

by Ecolab Inc

Reason
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Recall initiated
February 6, 2019
Reported by FDA
April 3, 2019
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-491-85

by Ecolab Inc

Reason
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Recall initiated
February 6, 2019
Reported by FDA
April 3, 2019
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-489-33

by Ecolab Inc

Reason
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Recall initiated
February 6, 2019
Reported by FDA
April 3, 2019
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Advanced Gel Hand Sanitizer (Ethyl alcohol 62%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-488-49) and b) 540 mL (18 fl oz) bottles (NDC 47593-488-31) Ecolab, 370 Wabasha Street N, St. Paul, MN 55102.

by Ecolab Inc

Reason
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Recall initiated
February 6, 2019
Reported by FDA
April 3, 2019
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Gel Hand Sanitizer (Ethyl Alcohol 70%), packaged in a) 37 mL (1.25 fl oz) bottles (NDC 47593-487-49), b) 118 mL (4 fl oz) bottles (NDC 47593-487-33), and c) 540 mL (18 fl oz) bottles (NDC47593-487-31) Ecolab, 370 Wabasha Street N, St. Paul, MN 55102.

by Ecolab Inc

Reason
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Recall initiated
February 6, 2019
Reported by FDA
April 3, 2019
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.

by Ingenus Pharmaceuticals Llc

Reason
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Recall initiated
March 18, 2019
Reported by FDA
April 3, 2019
Distribution
Nationwide in the USA and Puerto Rico.

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Drug Recall Terminated Historical recordClass II

Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-860-12), Rx only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
Recall initiated
March 22, 2019
Reported by FDA
April 3, 2019
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvine, CA 92612 U.S.A. NDC 0023-9211-05

by Allergan Sales, LLC

Reason
cGMP Deviations
Recall initiated
March 19, 2019
Reported by FDA
April 3, 2019
Distribution
TN only

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Drug Recall Terminated Historical recordClass II

Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals Inc. Made in India, NDC 23155-160-31

by Heritage Pharmaceuticals, Inc.

Reason
Subpotent Drug.
Recall initiated
February 15, 2019
Reported by FDA
March 27, 2019
Distribution
Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-125-90

by Rising Pharmaceuticals, Inc.

Reason
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Recall initiated
March 7, 2019
Reported by FDA
March 27, 2019
Distribution
Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.

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Drug Recall Ongoing Historical recordClass II

Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 ---- NDC 52343-124-90

by Rising Pharmaceuticals, Inc.

Reason
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Recall initiated
March 7, 2019
Reported by FDA
March 27, 2019
Distribution
Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.

View recall →

Drug Recall Ongoing Historical recordClass II

Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-123-90

by Rising Pharmaceuticals, Inc.

Reason
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Recall initiated
March 7, 2019
Reported by FDA
March 27, 2019
Distribution
Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Torrent Pharma Inc. Basking Ridge, NJ. Relabeled by: Preferred Pharmaceuticals, Inc. 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807.

by Preferred Pharmaceuticals, Inc

Reason
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
Recall initiated
March 6, 2019
Reported by FDA
March 27, 2019
Distribution
California, Georgia, Indiana

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Drug Recall Ongoing Historical recordClass II

Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-578-54

by Legacy Pharmaceutical Packaging LLC

Reason
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Recall initiated
March 1, 2019
Reported by FDA
March 27, 2019
Distribution
Wal-Mart distribution centers in AR, CA, GA, IN and MD

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Drug Recall Terminated Historical recordClass II

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15

by AVKARE Inc.

Reason
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Recall initiated
March 5, 2019
Reported by FDA
March 27, 2019
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15

by AVKARE Inc.

Reason
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Recall initiated
March 5, 2019
Reported by FDA
March 27, 2019
Distribution
Nationwide.

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.