Source
FDA Recalls
The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.
68,659Total Recalls
www.fda.gov →Official Site
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How to report to FDA →68,659 recalls
High RiskFDA
Wockhardt Usa Inc.
Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt L...
Oral Drugs539 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by...
Oral Drugs59,729 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), a...
Oral Drugs70,428 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bo...
Oral Drugs136,839 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679...
Injectable Drugs36,213 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-942-01), B) 500 Count Bottles (NDC: 64679-942-05), an...
Oral Drugs174,571 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-4...
Oral Drugs152,164 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-941-01), B) 500 Count Bottles (NDC: 64679-941-05), a...
Oral Drugs121,608 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Di...
Oral Drugs124,034 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64...
Oral Drugs112,120 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles ...
Oral Drugs53,894 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (...
Oral Drugs407,958 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distri...
Oral Drugs5,910 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-0...
Oral Drugs280,520 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05)...
Oral Drugs149,924 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0734-02), B) 500 Count Bo...
Oral Drugs132,409 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0737-02) and B) 500 Coun...
Oral Drugs33,422 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-0...
Oral Drugs162,743 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distribu...
Oral Drugs84,542 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the Counter. Manuf...
Oral Drugs848 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Dist...
Oral Drugs7,584 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and ...
Oral Drugs128,594 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mu...
Oral Drugs16,276 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India...
Injectable Drugs37,791 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distri...
Oral Drugs68,969 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count Bottles (ND...
Oral Drugs178,832 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distribu...
Oral Drugs68,066 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-...
Oral Drugs146,959 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distrib...
Oral Drugs491,360 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-0...
Oral Drugs216,329 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count B...
Oral Drugs77,967 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B) 500 Count Bottles (NDC: 64679-953-05...
Oral Drugs63,203 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt...
Oral Drugs1,002 affectedApr 22, 2015
High RiskFDA
Wockhardt Usa Inc.
Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), an...
Oral Drugs133,920 affectedApr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(B convenience custom kits used for general surgery in hospital operating room
Medical Devices615 affectedApr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom ki...
Medical Devices1,124 affectedApr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Cardiac Cath Pack, kit number AMS2707 convenience custom kits used for general surgery in hospital operating room
Cardiac Devices138 affectedApr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
C-Birth Pack, Kit part number AMS2037 and AMS2037(A convenience custom kits used for general surgery in hospital operating room
Medical Devices48 affectedApr 22, 2015
High RiskFDA
Lifeline Systems, Incorporated
Philips GoSafe Communicator 7000L Personal emergency response system.
Medical Devices3,189 affectedApr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Open Procedure Pack II, Kit number RMS1740(A convenience custom kits used for general surgery in hospital operating room
Medical Devices145 affectedApr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15 convenience custom kits used for general surgery in hospital operating room
Medical Devices356 affectedApr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Spine Pack, Kit number AMS3753 and AMS3783(A convenience custom kits used for general surgery in hospital operating room
Medical Devices86 affectedApr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800524001, Sterile, LD0608A - C Section - surgical kit containing cover light handle soft, RX. The responsible firm o...
Surgical Devices230 affectedApr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Foot Pack, Kit number AMS3637 convenience custom kits used for general surgery in hospital operating room
Medical Devices85 affectedApr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Minor Lap Pack, Kit number AMS2624 convenience custom kits used for general surgery in hospital operating room
Medical Devices130 affectedApr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm o...
Surgical Devices1,476 affectedApr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Set Up Pack, Kit number PSS3574(A convenience custom kits used for general surgery in hospital operating room
Medical Devices16 affectedApr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800408001, Sterile, LD0477A - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible fi...
Surgical Devices1,400 affectedApr 22, 2015