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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 12,261–12,280 of 17,974 drug recalls

Drug Recall Ongoing Historical recordClass II

Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0019-1 UPC 8 470002 075221

by Sesderma, SL

Reason
cGMP Deviations; product does not comply with cGMP requirements
Recall initiated
October 15, 2015
Reported by FDA
May 18, 2016
Distribution
Distributed to following states: FL, PR, CO, GA.

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Drug Recall Ongoing Historical recordClass II

Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 30, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0012-1 UPC8 429979 415691

by Sesderma, SL

Reason
cGMP Deviations; product does not comply with cGMP requirements
Recall initiated
October 15, 2015
Reported by FDA
May 18, 2016
Distribution
Distributed to following states: FL, PR, CO, GA.

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Drug Recall Ongoing Historical recordClass II

Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707

by Sesderma, SL

Reason
cGMP Deviations; product does not comply with cGMP requirements
Recall initiated
October 15, 2015
Reported by FDA
May 18, 2016
Distribution
Distributed to following states: FL, PR, CO, GA.

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Drug Recall Ongoing Historical recordClass II

Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain --- NDC 63181-0016

by Sesderma, SL

Reason
cGMP Deviations; product does not comply with cGMP requirements
Recall initiated
October 15, 2015
Reported by FDA
May 18, 2016
Distribution
Distributed to following states: FL, PR, CO, GA.

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Drug Recall Ongoing Historical recordClass II

Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0015-1, UPC 8 470003 244268

by Sesderma, SL

Reason
cGMP Deviations; product does not comply with cGMP requirements
Recall initiated
October 15, 2015
Reported by FDA
May 18, 2016
Distribution
Distributed to following states: FL, PR, CO, GA.

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Drug Recall Terminated Historical recordClass II

Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradation Specifications; 12 month stability time point
Recall initiated
March 30, 2016
Reported by FDA
May 18, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93

by Mylan Pharmaceuticals Inc.

Reason
Failed Dissolution Specifications; three month stability time point.
Recall initiated
February 12, 2016
Reported by FDA
May 18, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively by: A-S Medication Solutions LLC, Libertyville, ILL 60048, NDC 54569-8305-0

by A-S Medication Solutions LLC.

Reason
Labeling: Not elsewhere classified - count on the label was incorrect.
Recall initiated
April 22, 2016
Reported by FDA
May 11, 2016
Distribution
Virginia

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Drug Recall Terminated Historical recordClass II

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays per case (NDC 66689-401-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771

by VistaPharm, Inc.

Reason
Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
Recall initiated
April 18, 2016
Reported by FDA
May 11, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only, Manufactured by Teva Pharmaceuticals USA, Inc. Packaged by Bryant Ranch.

by Bryant Ranch Prepack Inc.

Reason
Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.
Recall initiated
March 25, 2016
Reported by FDA
May 11, 2016
Distribution
Nationwide

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Drug Recall Ongoing Historical recordClass III

Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA, NDC 0409-6629-02

by Hospira Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
Recall initiated
March 15, 2016
Reported by FDA
May 11, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-199-05, ALSO labeled as Premier Value Brand PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-0404-00.

by Akorn, Inc.

Reason
Presence of Particulate Matter
Recall initiated
April 7, 2016
Reported by FDA
May 11, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Service, Concord, NC 28027, NDC 63739-434-01.

by Mckesson Packaging Services

Reason
Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
Recall initiated
April 12, 2016
Reported by FDA
May 4, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30.

by AbbVie Inc.

Reason
Failed Content Uniformity Specifications
Recall initiated
March 24, 2016
Reported by FDA
April 27, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7077-14

by Hospira Inc.

Reason
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Recall initiated
March 8, 2016
Reported by FDA
April 27, 2016
Distribution
US: Nationwide and Singapore

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Drug Recall Terminated Historical recordClass II

Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2

by Hospira Inc.

Reason
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Recall initiated
March 8, 2016
Reported by FDA
April 27, 2016
Distribution
US: Nationwide and Singapore

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Drug Recall Terminated Historical recordClass II

Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-03 Barcode (01) 0 030409 417803 5

by Hospira Inc.

Reason
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Recall initiated
March 8, 2016
Reported by FDA
April 27, 2016
Distribution
US: Nationwide and Singapore

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Drug Recall Terminated Historical recordClass II

Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7935-19, Barcode (01) 0 030409 793519 2

by Hospira Inc.

Reason
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Recall initiated
March 8, 2016
Reported by FDA
April 27, 2016
Distribution
US: Nationwide and Singapore

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Drug Recall Terminated Historical recordClass II

Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7936-19, Barcode (01) 0 030409 793619 9

by Hospira Inc.

Reason
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Recall initiated
March 8, 2016
Reported by FDA
April 27, 2016
Distribution
US: Nationwide and Singapore

View recall →

Drug Recall Terminated Historical recordClass II

Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7918-19, Barcode (01) 0 030409 791819 5

by Hospira Inc.

Reason
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Recall initiated
March 8, 2016
Reported by FDA
April 27, 2016
Distribution
US: Nationwide and Singapore

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.