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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 9,161–9,180 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml sample packs and b) Net Wt. 2.0 oz (56.7g) bottles, BioLyte Laboratories - Grand Rapids, MI 49534, NDC 58368-002-02

by BioLyte Laboratories, LLC

Reason
CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product.
Recall initiated
August 31, 2018
Reported by FDA
October 10, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.

by Teva Pharmaceuticals USA

Reason
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Recall initiated
September 21, 2018
Reported by FDA
October 10, 2018
Distribution
Distributed nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottle. Distributed by: Boehinger Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877. Made in Germany. Marketed by: BI Pharmaceuticals, Inc. Ridgefield, CT 06877 and Eli Lilly and Company Indianapolis IN 46285 NDC 0597-0175-18

by Boehringer Ingelheim Pharmaceuticals, Inc.

Reason
Cross Contamination With Other Products:
Recall initiated
September 4, 2018
Reported by FDA
October 3, 2018
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India.

by Baxter Healthcare Corporation

Reason
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Recall initiated
September 25, 2018
Reported by FDA
October 3, 2018
Distribution
Nationwide USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.

by Hetero Labs Limited Unit V

Reason
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Recall initiated
August 20, 2018
Reported by FDA
October 3, 2018
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90

by Hetero Labs, Ltd. - Unit III

Reason
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Recall initiated
September 12, 2018
Reported by FDA
October 3, 2018
Distribution
Indiana and Louisiana

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Drug Recall Terminated Historical recordClass II

Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6675-8

by Noven Pharmaceuticals, Inc.

Reason
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Recall initiated
September 7, 2018
Reported by FDA
October 3, 2018
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8

by Noven Pharmaceuticals, Inc.

Reason
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Recall initiated
September 7, 2018
Reported by FDA
October 3, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6650-8

by Noven Pharmaceuticals, Inc.

Reason
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Recall initiated
September 7, 2018
Reported by FDA
October 3, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6610-8

by Noven Pharmaceuticals, Inc.

Reason
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Recall initiated
September 7, 2018
Reported by FDA
October 3, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. N+ and NOVAPLUS are registered trademarks of Vizient, Inc. NDC 43598-331-11

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Recall initiated
September 12, 2018
Reported by FDA
October 3, 2018
Distribution
Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.

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Drug Recall Terminated Historical recordClass III

Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Recall initiated
September 12, 2018
Reported by FDA
October 3, 2018
Distribution
Product was distributed to retailers, distributors, physician officers and medical facilities throughout the United States.

View recall →

Drug Recall Ongoing Historical recordClass I

Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30

by Hetero Labs Limited Unit V

Reason
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Recall initiated
August 15, 2018
Reported by FDA
October 3, 2018
Distribution
U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass III

Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01

by LUPIN SOMERSET

Reason
Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.
Recall initiated
August 23, 2018
Reported by FDA
September 26, 2018
Distribution
U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass III

Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788

by InvaGen Pharmaceuticals, Inc.

Reason
Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
Recall initiated
September 6, 2018
Reported by FDA
September 26, 2018
Distribution
Product was distributed to 14 major distributors who shipped the product U.S.A. nationwide.

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Drug Recall Terminated Historical recordClass III

MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03

by Jubilant Cadista Pharmaceuticals, Inc.

Reason
Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
Recall initiated
August 27, 2018
Reported by FDA
September 26, 2018
Distribution
Product was distributed throughout the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30

by Torrent Pharma Inc.

Reason
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Recall initiated
September 11, 2018
Reported by FDA
September 26, 2018
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Arthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7042-7

by Beaumont Bio-med, Inc.

Reason
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Recall initiated
August 31, 2018
Reported by FDA
September 26, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7012-7

by Beaumont Bio-med, Inc.

Reason
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Recall initiated
August 31, 2018
Reported by FDA
September 26, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Allergy & Hay Fever Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7011-7

by Beaumont Bio-med, Inc.

Reason
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Recall initiated
August 31, 2018
Reported by FDA
September 26, 2018
Distribution
Nationwide in the USA

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.