Product Recalls in 2015
5,758 recalls issued this year
305
CPSC
2,750
FDA Food
1,733
FDA Drug
970
NHTSA
FDA Drug
Class II
Terminated
Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
108 vials units
FDA Drug
Class II
Terminated
DMSO 99% Injection, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
187 vials units
FDA Drug
Class II
Terminated
Magnesium Sulfate 50% Injectable, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
320 vials units
FDA Drug
Class II
Terminated
Pyridoxine Injection, 100 mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
280 vials units
FDA Drug
Class II
Terminated
Glucosamine HCL Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
20 vials units
FDA Drug
Class II
Terminated
Chromium Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
30 vials units
FDA Drug
Class II
Terminated
L-Arginine Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
32 vials units
FDA Drug
Class II
Terminated
HCG (Lyophilized) Injectable, 5000 units/vial, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
1062 vials units
FDA Drug
Class II
Terminated
TNPRDC Injection, 6 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
171 vials units
NHTSA
Ongoing
Side Impact Air Bag Modules may Rupture
October 16, 2015
GENERAL MOTORS LLC
395 units
NHTSA
Ongoing
Undercarriage Ramp Rubbing Hydraulic Brake Line
October 16, 2015
Spartan Motors USA
209 units
FDA Drug
Class II
Terminated
Thiotic Acid Injection, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
7 vials units
FDA Drug
Class II
Terminated
L-Glutathione Injection, 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
467 vials units
NHTSA
Ongoing
Water Heater may be Wired Incorrectly
October 16, 2015
Starcraft RV
247 units
FDA Drug
Class II
Terminated
EDTA Disodium Injectable, 150mg/mL, 100mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
2279 vials units
FDA Drug
Class II
Terminated
Cyanocobalamin Buffered Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
20 vials units
FDA Drug
Class II
Terminated
Magnesium Sulfate Injectable, 14.28%, 7mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
160 vials units
FDA Drug
Class II
Terminated
Methylcobalamin Buffered Injectable, 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
186 vials units
FDA Drug
Class II
Terminated
Thiamine HCl Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
72 vials units
FDA Drug
Class II
Terminated
DMAE Dimethylaminoethanol Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
16 vials units
FDA Drug
Class II
Terminated
L-Tryptophan Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
16 vials units
NHTSA
Ongoing
Spare Tire Heat Shield Missing
October 16, 2015
Chrysler (FCA US LLC)
253 units
FDA Drug
Class II
Terminated
DMPS Injectable, 50mg/mL, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
475 vials units
FDA Drug
Class II
Terminated
Co-Enzyme Q-10 Injectable, 20mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
12 vials units
FDA Drug
Class II
Terminated
B12 Injection 12.5/12.5MG, 3mL, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
98 vials units
FDA Drug
Class II
Terminated
Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
74 vials units
FDA Drug
Class II
Terminated
Taurine Injectable, 50mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
October 16, 2015
Downing Labs, LLC
123 vials units
NHTSA
Ongoing
Wiring May Overheat
October 15, 2015
AIRSTREAM, INC.
564 units
FDA Food
Class II
Terminated
Martinelli's Sparkling Red Grape, 8.4 oz glass bottles (250 mL); Packed in 12 pack, UPC 0 41244 99926 2; item number 99926; 4/6 packs, Tray UPC 0 41244-64926 6, item number 64926 6 pack retail UPC
October 15, 2015
S. Martinelli & Co
10,983 trays of 12 packs , 9,998 trays of 4-6 packs units
FDA Food
Class II
Terminated
Red Velvet Bundt Cake
October 15, 2015
My Dads Favorite Cookies, LLC
9 units units
FDA Food
Class II
Terminated
Krispy Kreme Doughnuts, Chocolate Iced Custard Filled Doughnuts, 2 count, Net Wt. 4.65oz, and Half Dozen, Net Wt. 16.2 oz., Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winst
October 15, 2015
krispy kreme doughnut corporation
N/A units
NHTSA
Ongoing
Electro-Hydraulic Power Steering Loss
October 15, 2015
BMW OF NORTH AMERICA, LLC
86,018 units
FDA Drug
Class II
Ongoing
Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252166
October 15, 2015
Sesderma, SL
45 compacts units
FDA Food
Class II
Terminated
Krispy Kreme Doughnuts, Glazed Lemon Filled Doughnuts, (2 count, Net Wt. 4.65oz and Half Dozen, Net Wt. 16oz), Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston Salem, NC
October 15, 2015
krispy kreme doughnut corporation
N/A units
FDA Food
Class II
Terminated
Krispy Kreme Doughnuts, Signature Doughnuts, Half Dozen, Net Wt. 9.5oz, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston Salem, NC 27102.
October 15, 2015
krispy kreme doughnut corporation
N/A units
FDA Drug
Class II
Ongoing
Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252159
October 15, 2015
Sesderma, SL
44 compacts units
FDA Food
Class II
Terminated
Krispy Kreme Doughnuts, Original Glazed Doughnuts, 2 count, Net Wt. 3.5 oz., Half Dozen, Net Wt. 9.4oz and One Dozen, Net Wt. 18.7 oz., Manufactured under the authority of Krispy Kreme Doughnut Corpor
October 15, 2015
krispy kreme doughnut corporation
N/A units
FDA Drug
Class II
Ongoing
Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 16047-0029-1
October 15, 2015
Sesderma, SL
195 bottles units
FDA Drug
Class II
Ongoing
Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0
October 15, 2015
Sesderma, SL
66 bottles units
FDA Drug
Class II
Ongoing
Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0019-1 UPC 8 470002 075221
October 15, 2015
Sesderma, SL
354 bottles units
FDA Food
Class II
Terminated
Krispy Kreme Doughnuts, Glazed Raspberry Filled Doughnuts, 2 count, Net Wt. 4.65oz, and Half Dozen, Net Wt. 16 oz., Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston Salem
October 15, 2015
krispy kreme doughnut corporation
N/A units
FDA Drug
Class II
Ongoing
Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain --- NDC 63181-0016
October 15, 2015
Sesderma, SL
459 bottles units
FDA Food
Class II
Terminated
Martinelli's Sparkling Northwest Blend Cider , 8.4 oz glass bottles (250 mL); Packed in 12 pack, UPC 0 41244 99057 5; item number 99957; Single 8.4 oz. bottle - UPC 0 41244 99057 3.
October 15, 2015
S. Martinelli & Co
203,989 trays of 12 packs units
FDA Drug
Class II
Ongoing
Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, ND
October 15, 2015
Sesderma, SL
15 bottles units
FDA Food
Class II
Terminated
Krispy Kreme Doughnuts, Glazed Doughnuts with Kreme Filling, Half Dozen Net Wt. 16 oz, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston Salem, NC 27102.
October 15, 2015
krispy kreme doughnut corporation
N/A units
FDA Food
Class II
Terminated
Assorted Large Cupcakes, 2 pack and 1 pack
October 15, 2015
My Dads Favorite Cookies, LLC
60 units (5 dozen) units
FDA Food
Class II
Terminated
Elegant sophistication gift basket containing apple cidar in glass bottles. The label on the back of the gift basket is white with black lettering.
October 15, 2015
DesignPac Gifts Inc LLC
560 units (gift baskets) units
NHTSA
Ongoing
Slide Mechanism Power Bypasses Circuit Breaker
October 15, 2015
FOREST RIVER, INC.
89 units
FDA Food
Class II
Terminated
Martinelli's Gold Medal Sparkling Cider, 8.4 oz glass bottles; Packed in 12 pack, UPC 0 41244 00256; item number 12256; 4/6 packs, Tray UPC 0 41244-99932 3, item number 46256; 6 pack Retail UPC 0
October 15, 2015
S. Martinelli & Co
166,804 trays of 12 packs, 31,939 trays of 4-6 packs units
FDA Food
Class II
Terminated
Martinelli's Sparkling White Grape, 8.4 oz glass bottles (250 mL); Packed in 12 pack, UPC 0 41244 99925 5; item number 99925; Single 8.4 oz. bottle - UPC 0 41244 99025 2.
October 15, 2015
S. Martinelli & Co
25,890 trays of 12 packs units