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
Pharmakon Pharmaceuticals, Inc.
Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, ...
Drugs384 affectedApr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Rocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0955-70
Drugs1,925 affectedApr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46...
Drugs70 affectedApr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 460...
Drugs40 affectedApr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride 250 mL Intravia Bag, Rx Only, Compounded by PHARMAKON Pharmaceut...
Drugs595 affectedApr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060...
Drugs1,809 affectedApr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceutical...
Drugs725 affectedApr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Cefazolin 2GM added to 5% Dextrose 50 mL USP, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0610-41
Drugs1,450 affectedApr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 4606...
Drugs200 affectedApr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Monoject Syringe, Rx Only, Compounded by PHARMAKON Pharmaceutic...
Drugs120 affectedApr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Ketamine 20 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, N...
Drugs175 affectedApr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Succinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0...
Drugs2,175 affectedApr 20, 2016
High RiskFDA
Acorn Stairlifts, Inc
Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift
Medical Devices26,428 affectedApr 20, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
Diagnostic Devices80 affectedApr 20, 2016
High RiskFDA
Helena Laboratories, Inc.
Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPOR...
Diagnostic Devices12 affectedApr 20, 2016
High RiskFDA
Csm Bakery Products Na
¿ Sheet Unbaked Message Cookie, 20/20 oz. Unbaked Chocolate Chip Cookies, Net Weight 25 lbs/11.34 kg.
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
Sugar, Frozen Pre-cut Cookie Dough, Net Weight 24.61 lbs/11.16 kgs and 23.44 lbs/10.64 kgs.
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
0.5 oz. TranSmart, Mini Sugar Cookie Dough, Net Weight 22.5 lbs (10.20 kg).
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
TranSmart, 12 Chocolate Chip Message Cookie, 24/24 ounce chocolate chip cookies in Bakeable Plastic Pans with Domes, Net Weight 36 lbs/16...
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
TranSmart, 4 oz. Oatmeal Raisin Walnut Cookie Dough, Net Weight 24 lbs (10.88 kg).
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
Cinnabon Cinnamon Chip, 3 oz. Cookie, Net Weight 23.43 lbs (10.63 kg).
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
Oatmeal Raisin, Frozen Pre-cut Cookie Dough, Net Weight 23.44 lbs/10.63 kgs and 24.61 lbs (11.16 kgs)
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
TransSmart, Brownie Cookie, 300 1.2oz Cookies, Net Weight 22.5 lbs/10.22 kg.
Bakery & Grains34,525 affectedApr 19, 2016
CriticalFDA
Nuvi Global Corporation
Nuvi Global StemVitae Multivitamin 30oz.
Supplements273 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
Oatmeal Raisin, TranSmart Frozen Pre-cut Cookie Dough, Contains Approx. 120 Cookies, Net Weight 22.5 lbs (10.22 kgs).
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
4 oz. Macadamia Nut Cookie Dough, TranSmart, Net Weight 24 lbs/10.9 kg.
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
2 oz. TranSmart, Macadamia White Chocolate Cookie Dough, Net Weight 30 lbs (13.6 kg).
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
TranSmart Gourmet Mini Bites Wedding Cookie, 576, .75oz cookies, Net Wt 27 lbs/12.26 kg.
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
1.25 oz. TranSmart, Chocolate Chip Cookie Dough, Net Weight: 23.44 lbs. (10.63 kg).
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
TranSmart, 1.2 oz. Sugar Cookie, Net Weight: 22.5 lbs (10.2 kg).
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
TranSmart, Sugar Cookie Dough, 576/0.75 ounce cookies, Net Weight 27 lbs/12.26 kgs and 96/4 ounce cookies, Net Weight 24 lbs/10.9 kgs.
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
Chocolate Chip, TranSmart, Frozen Pre-cut Cookie Dough, Net Weight 22.5 lbs (10.22 kgs).
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
1 oz. Dutch Cupboard, Oatmeal Raisin Cookie Dough, Net Weight: 22.5 lbs (10.20 kg).
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
7 Eleven, Sugar Cookie (2.2 oz. Pucks), Net Weight 33 lbs (14.96 kg), Manufactured by; CSM Bakery, Tucker, GA 30084.
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
7 Eleven, Oatmeal Raisin Cookie (2.2 oz. Pucks)/ Net Weight 33 lbs (14.96 kg), Made in the USA By: CSM Bakery, Inc., Tucker, GA 30084.
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
Dutch Cupboard, Sugar Cookie Dough, 360 1.1 ounce cookies, Net Weight: 24.75 lbs/11.24 kgs.
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
TranSmart White Chunk Macadamia Nut, 168 2.5 oz. Cookies, Net Weight: 26.25 lbs 11.91 kg.
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
TranSmart, White Chocolate Chip Fudge Cookie, 240 1.5 oz. Cookies, Net Weight: 22.5 lbs/10.21 kg.
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
Chocolate Chip Cookie, Net Weight: 21 lbs (9.53 kgs).
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
TranSmart, Chocolate Chip Cookie, 240 1.5oz cookies, Net Weight 22.5 lbs/10.21 kg.
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
ARBYS Salted Caramel Chocolate Cookie, Net Weight 22.96 lbs (10.41 kg).
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
0.75 oz. TransSmart, Gourmet Mini Bites, Brownie Cookie Dough, Net Wt: 27 lbs (12.24 kg).
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
Macadamia Nut Cookie with White Drops, TranSmart, Frozen Pre-cut Cookie Cough, Net Weight 22.5 lbs (10.22 kgs).
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
FLIK, ZT Thin & Crispy Chocolate Chip Cookies, Contains 300 cookies weighing approximately 1.2 oz, Net Weight 22.5 lbs (10.2 kg), Manufac...
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
Candy Frozen Cookie Pucks 0.75oz, Keep Frozen, Net Weight 27 lbs (12.24 kg).
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
Cinnabon Caramel Pecan, 3 oz. Cookie, Net Weight 23.45 lbs. (10.63 kg).
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
Chocolate Chip, Frozen Pre-cut Cookie Dough, Net Weight: 24.61 lbs/11.17 kgs and 23.44 lbs/10.63 kgs.
Bakery & Grains34,525 affectedApr 19, 2016
High RiskFDA
Csm Bakery Products Na
0.5 oz. TranSmart, Mini Chocolate Chip Cookies with M&Ms, Net Weight 22.5 lbs (10.20 kg).
Bakery & Grains34,525 affectedApr 19, 2016