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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 9,181–9,200 of 17,974 drug recalls

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.

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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.

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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

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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

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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

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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

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Drug Recall Terminated Historical recordClass II

Muscle & Joint 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 58066-7041-7

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

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Drug Recall Terminated Historical recordClass II

Diarrhea 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 58066-7022-7

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

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Drug Recall Terminated Historical recordClass II

Sore Throat & Laryngitis 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 58066-7014-7

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

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Drug Recall Terminated Historical recordClass II

Sinus 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 58066-7013-7

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

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Drug Recall Terminated Historical recordClass II

Skin Irritation & Itch 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 58066-7002-7

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

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Drug Recall Terminated Historical recordClass II

Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153

by Dr. Reddy's Laboratories, Inc.

Reason
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Recall initiated
September 4, 2018
Reported by FDA
September 26, 2018
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31

by Baxter Healthcare Corporation

Reason
cGMP Deviation
Recall initiated
September 6, 2018
Reported by FDA
September 26, 2018
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass I

Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417.

by QuVa Pharma, Inc.

Reason
Subpotent Drug: Product may not have the active ingredient present in the bag.
Recall initiated
August 27, 2018
Reported by FDA
September 26, 2018
Distribution
Nationwide to hospitals in USA

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Drug Recall Terminated Historical recordClass I

Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703; Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, India; NDC 16729-182-01.

by ACCORD HEALTHCARE, INC.

Reason
Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
Recall initiated
August 21, 2018
Reported by FDA
September 19, 2018
Distribution
Nationwide in the USA and Puerto Rico.

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Drug Recall Terminated Historical recordClass I

Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-003-02

by Hellolife

Reason
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Recall initiated
August 23, 2018
Reported by FDA
September 19, 2018
Distribution
Nationwide USA, Algeria Australia Belgium Brazil Bulgaria Canada Colombia Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Estonia French Polynesia Greece Guadeloupe Guam Hong Kong Hungary India Ireland Israel Italy Latvia Lithuania Martinique Mexico Monaco Netherlands New Zealand Norway Peru Poland Portugal Romania Russia Russian Federation Saudi Arabia Senegal Serbia Slovakia Slovakia (Slovak Republic) Slovenia Swaziland Sweden Swit

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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.