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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 17,641–17,660 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass I

BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146 Diluent manufactured by: Luitpold Pharmaceuticals, Inc. Shirley, NY 11967 Distributed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA Made in USA NDC 0015-3012-18 NDC 0015-3012-60

by Bristol-Myers Squibb Company

Reason
Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured by BenVenue Laboratories (BVL) are being recalled because of an overfilled vial discovered during stability testing for a single carmustine lot.
Recall initiated
August 29, 2012
Reported by FDA
October 31, 2012
Distribution
Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Earth Force, Ltd., Power Towels, QS Plus Hand Sanitizing Wipes (antiseptic), 50 pre-moistened Wipes, Manufactured by: ABC Compounding Co., Inc., P.O. Box 16247, Atlanta, GA 30321.

by Abc Compounding Company Inc

Reason
Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (7820, Graffiti Remover).
Recall initiated
February 10, 2011
Reported by FDA
October 31, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-5092-21.

by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals

Reason
Tablet Separation: Possibility of cracked or split coating on the tablets.
Recall initiated
October 11, 2012
Reported by FDA
October 31, 2012
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement, sold in a) 2 fl.oz (59.15 mL), b) 8 fl.oz (236.6 mL), c) 16 fl.oz (473.2 mL), d) 32 fl.oz (946.4 mL), e) 64 fl.oz (1.89 L), and f) 1 Gal. (3.78 L), Distributed by: Earthborn Products, San Diego, CA 92103.

by Earthborn Products, Inc.

Reason
Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final rule establishing that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded.
Recall initiated
October 5, 2012
Reported by FDA
October 24, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33

by Sandoz Incorporated

Reason
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Recall initiated
September 20, 2012
Reported by FDA
October 24, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0110-01 ,

by Paddock Laboratories, LLC

Reason
Paddock Laboratories, LLC are recalling one lot (2012028142) of Moexipril HCl Tablets 7.5mg (expiration 1/2014) because of a non-conformity dissolution failure result found during routine stability testing at the 6 month test interval.
Recall initiated
October 3, 2012
Reported by FDA
October 17, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic LLC., 1877 Kawaii Road, Lincolnton, NC 28092 USA, NDC 0472-1629-16

by Actavis Mid Atlantic LLC

Reason
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Recall initiated
August 14, 2012
Reported by FDA
October 17, 2012
Distribution
Nationwide & Puerto Rico

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Drug Recall Terminated Historical recordClass III

Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic, LLC., 1877 Kawaii Road, Lincolnton, NC, 28092, USA, NDC 0472-1628-16.

by Actavis Mid Atlantic LLC

Reason
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Recall initiated
August 14, 2012
Reported by FDA
October 17, 2012
Distribution
Nationwide & Puerto Rico

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Drug Recall Terminated Historical recordClass III

Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01

by Mylan Pharmaceuticals Inc.

Reason
Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
Recall initiated
June 28, 2012
Reported by FDA
October 10, 2012
Distribution
Nationwide and PR

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Drug Recall Terminated Historical recordClass II

ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01.

by CareFusion 213, LLC

Reason
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
Recall initiated
April 23, 2012
Reported by FDA
October 10, 2012
Distribution
IL, MO, and NJ

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Drug Recall Terminated Historical recordClass II

Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of Sun Pharmaceutical Industries, Inc.

by Caraco Pharmaceutical Laboratories Ltd.

Reason
Crystallization: Presence of crystals of Nimodipine within the capsule solution.
Recall initiated
August 21, 2012
Reported by FDA
October 10, 2012
Distribution
One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts

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Drug Recall Terminated Historical recordClass III

buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 450 10 3, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-450-10, carton barcode 6373945010.

by Mckesson Packaging Services

Reason
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Recall initiated
March 29, 2012
Reported by FDA
October 10, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 449 10 7, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-449-10, carton barcode 6373944910.

by Mckesson Packaging Services

Reason
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Recall initiated
March 29, 2012
Reported by FDA
October 10, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05

by Mylan Pharmaceuticals Inc.

Reason
Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.
Recall initiated
July 27, 2012
Reported by FDA
October 3, 2012
Distribution
The product was distributed to KY.

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Drug Recall Terminated Historical recordClass II

NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430; NDC 68462-190-01.

by Glenmark Generics Inc., USA

Reason
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
Recall initiated
July 6, 2012
Reported by FDA
October 3, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipotropic (fat dissolving) agent, OTC, Distributed by Vitaminbestbuy.com, Brewerton, NY

by www.vitaminbestbuy.com

Reason
Marketed Without an Approved ANDA/NDA: presence of sibutramine
Recall initiated
February 23, 2012
Reported by FDA
October 3, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Man King Capsules, 2800 mg, boxes of 5 packets, OTC, Developed by: American Wanbao Pharmaceutical International Group and Hainan Wanbao Biological Engineering Co., Ltd., 27 Heping Road, Haikou, Henan Province, UPC 9 009900 0032328

by www.vitaminbestbuy.com

Reason
Marketed Without an Approved ANDA/NDA: presence of sildenafil.
Recall initiated
February 23, 2012
Reported by FDA
October 3, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company, Unit 18, 55 Beijing Road Central, Lhasa, Tibet

by www.vitaminbestbuy.com

Reason
Marketed Without an Approved ANDA/NDA: presence of sildenafil
Recall initiated
February 23, 2012
Reported by FDA
October 3, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr. By: Ben Venue Laboratories, Bedford, OH 44146: Mfg for: Bedford Labs, Bedford, OH 44146, NDC 55390-039-10.

by Ben Venue Laboratories Inc

Reason
Presence of Particulate Matter
Recall initiated
June 26, 2012
Reported by FDA
October 3, 2012
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-9296-90

by Abbott Laboratories

Reason
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Recall initiated
July 19, 2012
Reported by FDA
October 3, 2012
Distribution
Nationwide

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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.