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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 10,621–10,640 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-462-69

by Alvogen, Inc

Reason
Lack of Assurance of Sterility
Recall initiated
June 16, 2017
Reported by FDA
July 12, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056, NDC 0116-2001-16

by Xttrium Laboratories Inc

Reason
CGMP Deviations
Recall initiated
June 1, 2017
Reported by FDA
July 12, 2017
Distribution
Natiowide

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Drug Recall Terminated Historical recordClass II

Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 g container (NDC: 58597-8023-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

by American Pharmaceutical Ingredients LLC

Reason
CGMP Deviations: Lack of quality assurance at the API manufacturer.
Recall initiated
May 26, 2017
Reported by FDA
July 12, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-023-09

by Pharmedium Services Llc

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date
Recall initiated
February 15, 2017
Reported by FDA
July 12, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 270 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-044-57

by Pharmedium Services Llc

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date
Recall initiated
February 15, 2017
Reported by FDA
July 12, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium Chloride Injection, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-100-13

by Pharmedium Services Llc

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date
Recall initiated
February 15, 2017
Reported by FDA
July 12, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 600 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-279-33

by Pharmedium Services Llc

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date
Recall initiated
February 15, 2017
Reported by FDA
July 12, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-25

by Pharmedium Services Llc

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date
Recall initiated
February 15, 2017
Reported by FDA
July 12, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-03

by Pharmedium Services Llc

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date
Recall initiated
February 15, 2017
Reported by FDA
July 12, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-256-09

by Pharmedium Services Llc

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date
Recall initiated
February 15, 2017
Reported by FDA
July 12, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured by Allergan, Irvine, California, 92612, U.S.A., NDC: 0023-0313-04.

by Allergan Sales, LLC

Reason
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Recall initiated
May 1, 2017
Reported by FDA
July 5, 2017
Distribution
Nationwide in the US

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Drug Recall Terminated Historical recordClass III

BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center, Suite 400, Princeton, NJ 08805, NDC: 63739-706-10

by Mckesson Packaging Services

Reason
Failed Moisture Limits: Product tested out-of-specification for moisture content.
Recall initiated
May 30, 2017
Reported by FDA
July 5, 2017
Distribution
Nationwide in the US

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Drug Recall Terminated Historical recordClass II

Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4), b) 100 g packaged in 16 oz container (NDC: 58597-8082-6), c) 500 g packaged in a 2500 cc container (NDC: 58597-8082-7) and a 1,000 g packaged in 1 gallon container (NDC: 58597-8082-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

by American Pharmaceutical Ingredients LLC

Reason
Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
Recall initiated
June 1, 2017
Reported by FDA
July 5, 2017
Distribution
Nationwide in the US

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Drug Recall Terminated Historical recordClass III

Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count bottles, Distributed by: GlaxoSmithKline Consumer Healthcare, L.P., Moon Twp, PA 15108, UPC 3 0088-1175-47 8.

by Sanofi-Aventis U.S. LLC

Reason
Superpotent Drug: high out-of-specification result for magnesium.
Recall initiated
June 12, 2017
Reported by FDA
July 5, 2017
Distribution
Nationwide in the USA, Puerto Rico, and the United Kingdom.

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Drug Recall Terminated Historical recordClass III

Walgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two plastic 12FL OZ (355 mL) bottles connected by one paper sleeve, TOTAL 24 FL OZ (1.5 pt)(710 mL), OTC, Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015

by L. Perrigo Company

Reason
Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the product twin pack. The incorrect product sleeve is for Day-Night Cold and Flu whereas the batch contains Day-Night Cough Liquid.
Recall initiated
June 5, 2017
Reported by FDA
July 5, 2017
Distribution
IL

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Drug Recall Terminated Historical recordClass II

Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Street, Portland, ME.

by Apothecary By Design

Reason
Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.
Recall initiated
June 5, 2017
Reported by FDA
July 5, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8

by Noven Pharmaceuticals, Inc.

Reason
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Recall initiated
April 27, 2017
Reported by FDA
July 5, 2017
Distribution
Nationwide within US

View recall →

Drug Recall Terminated Historical recordClass II

Magnesium Citrate Saline Laxative Cherry Flavored, packaged in a) 10 fl. oz. (296 mL) bottle UPC: 072785104556 (Rexall's label), b) 10 fl. oz. (296 mL) bottle UPC: 041163254138 (Equaline's label), OTC, Distributed by a) Dolgencorp, LL, Goodlettsville, TN 37072 b)Supervalu, Inc. Eden Prairie, MN 55344

by Vi-Jon, Inc.

Reason
Presence of foreign substance: glass particle
Recall initiated
June 12, 2017
Reported by FDA
June 28, 2017
Distribution
Nationwide U.S.A.

View recall →

Drug Recall Terminated Historical recordClass II

Venlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg, packaged in a) 30-count bottles (NDC 52343-132-30) and b) 90-count bottles (NDC 52343-132-90), Rx only, Distributed by: Lucid Pharma LLC, 2 Tower Center Blvd, Suite-1101-B, East Brunswick, NJ 08816 USA.

by Lucid Pharma LLC

Reason
Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules.
Recall initiated
June 1, 2017
Reported by FDA
June 28, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93

by Mylan Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Recall initiated
May 9, 2017
Reported by FDA
June 21, 2017
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.