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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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Drug Recall Terminated Historical recordClass II

Kleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl oz. (236mL) , and c) 16 fl oz (473mL) bottles, Distributed by Kimberly Clark, LLC, Roswell, GA 30076

by Kimberly-Clark Corporation

Reason: Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
Recall initiated: June 14, 2012
Reported by FDA: July 18, 2012
Distribution: Nationwide and Canada

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Drug Recall Terminated Historical recordClass II

Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl oz.), b) 1.2 Liters (40.5 fl oz.) Cassettes, Distributed by Kimberly Clark, LLC, Roswell, GA 30076

by Kimberly-Clark Corporation

Reason: Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
Recall initiated: June 14, 2012
Reported by FDA: July 18, 2012
Distribution: Nationwide and Canada

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Drug Recall Terminated Historical recordClass II

Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12.

by Noven Pharmaceuticals, Inc.

Reason: Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
Recall initiated: March 22, 2012
Reported by FDA: July 18, 2012
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets, Rx only, Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709 by: GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 49702-217-18

by GlaxoSmithKline Inc

Reason: Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.
Recall initiated: June 4, 2012
Reported by FDA: July 18, 2012
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.

by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals

Reason: Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Recall initiated: July 6, 2012
Reported by FDA: July 18, 2012
Distribution: Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count bottle, Rx only, Manufactured for: AstraZeneca LP, Wilmington, DE 19850; By: AstraZeneca AB, S-151 85 Sodertalje, Sweden, NDC 0186-5040-85, UPC 3 0186-5040-85 0.

by ASTRA ZENECA Lp

Reason: Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.
Recall initiated: July 2, 2012
Reported by FDA: July 18, 2012
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass III

Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01

by Watson Laboratories Inc

Reason: Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Recall initiated: April 17, 2012
Reported by FDA: July 11, 2012
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass II

Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactured in india By: Emcure Pharmaceuticals LTD. Hinjwadi, Pune, India, Manufactured for TEVA Phamaceuticals USA, Sellersville, PA 18960, NDC 0093-0733-10

by Teva Pharmaceuticals USA, Inc.

Reason: Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)
Recall initiated: May 16, 2012
Reported by FDA: July 11, 2012
Distribution: Ohio

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Drug Recall Terminated Historical recordClass II

Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20

by sanofi-aventis US, Inc.

Reason: CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
Recall initiated: February 6, 2012
Reported by FDA: July 11, 2012
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass II

Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10

by sanofi-aventis US, Inc.

Reason: CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
Recall initiated: February 6, 2012
Reported by FDA: July 11, 2012
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass III

Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 doses, 100 capsules, Manufactured by: healthPLUS Inc. Chino, CA 91710 USA.

by Health Plus Incorporated

Reason: Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Facts box incorrectly states "Active Ingredients per dose" Senna Leaf powder 140 mg. It should correctly be stated as "Active ingredient (in each capsule)" Senna Leaf Powder 140 mg.It should correctly be stated as Active ingredient (in each capsule) Senna Leaf Powder 140 mg.
Recall initiated: June 28, 2012
Reported by FDA: July 11, 2012
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed by Ranbaxy, Jacksonville, FL 32257, NDC 10631-106-08

by Ranbaxy Inc.

Reason: Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
Recall initiated: March 16, 2012
Reported by FDA: July 11, 2012
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg, 18 count blister pack cartons, McNeil Consumer Healthcare, Div of McNeil-PPC Inc., Fort Washington, PA

by Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.

Reason: Defective Container; damaged blister units
Recall initiated: May 17, 2012
Reported by FDA: July 11, 2012
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01

by Watson Laboratories Inc

Reason: Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Recall initiated: April 17, 2012
Reported by FDA: July 11, 2012
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass III

Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01

by Watson Laboratories Inc

Reason: Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Recall initiated: April 17, 2012
Reported by FDA: July 11, 2012
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass III

Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01

by Watson Laboratories Inc

Reason: Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Recall initiated: April 17, 2012
Reported by FDA: July 11, 2012
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass III

Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01.

by Watson Laboratories Inc

Reason: Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Recall initiated: April 17, 2012
Reported by FDA: July 11, 2012
Distribution: Nationwide.

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Drug Recall Terminated Historical recordClass II

Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01

by Shionogi Inc.

Reason: Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Recall initiated: March 8, 2012
Reported by FDA: July 4, 2012
Distribution: PA

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Drug Recall Terminated Historical recordClass II

Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons containing three (3) individual blister packs

by Teva Pharmaceuticals USA, Inc.

Reason: Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.
Recall initiated: May 2, 2012
Reported by FDA: July 4, 2012
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs per carton, Rx only, Teva Pharmaceuticals USA Sellersville, PA 18960, Individual blister pack: NDC 0555-0171-88, 25 Unit-Dose Tablets (5x5) Carton: NDC 0555-0171-78

by Teva Pharmaceuticals USA, Inc.

Reason: Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.
Recall initiated: April 2, 2012
Reported by FDA: July 4, 2012
Distribution: Nationwide

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Data last updated: October 4, 2026 ET

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.