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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 6,301–6,320 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.)

by Glaxosmithkline Consumer Healthcare Holdings

Reason
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Recall initiated
March 16, 2020
Reported by FDA
April 1, 2020
Distribution
Product was distributed throughout the United States, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95

by Glaxosmithkline Consumer Healthcare Holdings

Reason
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Recall initiated
March 16, 2020
Reported by FDA
April 1, 2020
Distribution
Product was distributed throughout the United States, including Puerto Rico.

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Drug Recall Terminated Historical recordClass II

Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, item # F00573019620C, 20 ct. blister NDC 0573-0196-10, item # F00573019610R, 10 ct. blister

by Glaxosmithkline Consumer Healthcare Holdings

Reason
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Recall initiated
March 16, 2020
Reported by FDA
April 1, 2020
Distribution
Product was distributed throughout the United States, including Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only, Manufactured for: Jubilant Draximage, Inc., Kirkland, Quebec, Canada, NDC 65174-288-05, 67175-288-30

by Jubilant Draximage Inc

Reason
Failed Stability Specifications
Recall initiated
March 19, 2020
Reported by FDA
April 1, 2020
Distribution
Product was distributed throughout the United States.

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Drug Recall Terminated Historical recordClass II

Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.

by PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Reason
SubPotent Drug: Low out-of-specification results for assay testing.
Recall initiated
March 19, 2020
Reported by FDA
April 1, 2020
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC 29033-001-01.

by Nostrum Laboratories Inc

Reason
CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.
Recall initiated
March 6, 2020
Reported by FDA
April 1, 2020
Distribution
TN, MO

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Drug Recall Terminated Historical recordClass III

Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01

by Mylan Pharmaceuticals Inc.

Reason
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Recall initiated
March 23, 2020
Reported by FDA
April 1, 2020
Distribution
U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass II

Buprenorphine Black Cherry 2 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida

by Matthew 7:25 Inc dba Thrive Pharmacy

Reason
Subpotent Drug
Recall initiated
March 10, 2020
Reported by FDA
April 1, 2020
Distribution
Florida

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Drug Recall Terminated Historical recordClass II

Buprenorphine Watermelon 8 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida

by Matthew 7:25 Inc dba Thrive Pharmacy

Reason
Subpotent Drug
Recall initiated
March 10, 2020
Reported by FDA
April 1, 2020
Distribution
Florida

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Drug Recall Terminated Historical recordClass II

Buprexone Banana cream 6-0.6 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida

by Matthew 7:25 Inc dba Thrive Pharmacy

Reason
Subpotent Drug
Recall initiated
March 10, 2020
Reported by FDA
April 1, 2020
Distribution
Florida

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Drug Recall Terminated Historical recordClass III

Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist. by Energique, Inc., 201 Apple Blvd., Woodbine, IA 51579, NDC 44911-0411-1

by Grato Holdings, Inc.

Reason
Labeling mix-up - Indications on product label are incorrect.
Recall initiated
November 15, 2019
Reported by FDA
April 1, 2020
Distribution
U.S.A. Nationwide, Israel

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Drug Recall Terminated Historical recordClass II

Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90

by Jubilant Cadista Pharmaceuticals, Inc.

Reason
CGMP Deviations: Presence of dark brown discoloration on edges of tablets
Recall initiated
March 11, 2020
Reported by FDA
March 25, 2020
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-count bottles (NDC 51991-894-90), Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pithampur 454 775, Dist, Dhar Madhya Pradesh, INDIA

by Breckenridge Pharmaceutical, Inc

Reason
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Recall initiated
January 24, 2020
Reported by FDA
March 25, 2020
Distribution
Product was distributed nationwide within the United States.

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Drug Recall Terminated Historical recordClass II

Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33) and b) 90-count bottles (NDC 51991-893-90) Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pithampur 454 775, Dist, Dhar Madhya Pradesh, INDIA

by Breckenridge Pharmaceutical, Inc

Reason
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
Recall initiated
January 24, 2020
Reported by FDA
March 25, 2020
Distribution
Product was distributed nationwide within the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05

by Sun Pharmaceutical Industries, Inc.

Reason
Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
Recall initiated
March 9, 2020
Reported by FDA
March 25, 2020
Distribution
U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours (1.6 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5553-3

by Noven Therapeutics, LLC

Reason
Defective Delivery System: Out of specification for mechanical peel and shear.
Recall initiated
March 2, 2020
Reported by FDA
March 25, 2020
Distribution
U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass I

UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack, c) ten pack capsules per carton, Exclusively Manufactured and Formulated by: Buy Wise Marketing, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783, Ultimatepleasure2.com.

by Med Man Distribution, Inc.

Reason
Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Recall initiated
November 8, 2019
Reported by FDA
March 25, 2020
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-01; NDC Berkley Jensen: 68391-852-56; NDC: CVS Health: 59779-540-01; NDC DG Health: 55910-011-01; NDC Kirkland: 63981-852-56; NDC Kroger: 30142-600-56; NDC Meijer: 41250-852-01; NDC Rite Aid: 11822-0852-4; NDC Walgreens: 0363-0852-01

by Perrigo Company PLC

Reason
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recall initiated
October 23, 2019
Reported by FDA
March 25, 2020
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75

by Perrigo Company PLC

Reason
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recall initiated
October 23, 2019
Reported by FDA
March 25, 2020
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC Good Neighbor Pharmacy: 46122-533-09; NDC Kroger: 30142-891-09; NDC Topcare: 36800-950-09; NDC Up & Up: 11673-950-09; NDC Walgreens: 0363-0950-09

by Perrigo Company PLC

Reason
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recall initiated
October 23, 2019
Reported by FDA
March 25, 2020
Distribution
Nationwide 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.