Product Recalls in 2018
4,666 recalls issued this year
258
CPSC
1,746
FDA Food
1,681
FDA Drug
981
NHTSA
FDA Drug
Class II
Ongoing
Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.
December 31, 2018
Aurobindo Pharma USA Inc
20,604 bottles units
FDA Drug
Class II
Ongoing
Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-740-30.
December 31, 2018
Aurobindo Pharma USA Inc
55,788 bottles units
FDA Drug
Class II
Ongoing
Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-570-30
December 31, 2018
Aurobindo Pharma USA Inc
N/A units
FDA Drug
Class II
Ongoing
Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30
December 31, 2018
Aurobindo Pharma USA Inc
N/A units
FDA Drug
Class II
Ongoing
Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90
December 31, 2018
Aurobindo Pharma USA Inc
N/A units
FDA Drug
Class II
Ongoing
Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90.
December 31, 2018
Aurobindo Pharma USA Inc
53,064 bottles units
FDA Drug
Class II
Ongoing
Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90.
December 31, 2018
Aurobindo Pharma USA Inc
92,616 bottles units
FDA Drug
Class II
Ongoing
Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-738-30.
December 31, 2018
Aurobindo Pharma USA Inc
27,688 bottles units
FDA Drug
Class II
Ongoing
Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90.
December 31, 2018
Aurobindo Pharma USA Inc
111,239 bottles units
FDA Drug
Class II
Ongoing
Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90.
December 31, 2018
Aurobindo Pharma USA Inc
23,016 bottles units
FDA Drug
Class II
Ongoing
Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30
December 31, 2018
Aurobindo Pharma USA Inc
18,408 bottles units
FDA Drug
Class II
Ongoing
Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90
December 31, 2018
Aurobindo Pharma USA Inc
N/A units
FDA Drug
Class II
Ongoing
Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90
December 31, 2018
Aurobindo Pharma USA Inc
N/A units
FDA Drug
Class II
Ongoing
Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90.
December 31, 2018
Aurobindo Pharma USA Inc
32,160 bottles units
FDA Drug
Class II
Ongoing
Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-739-30.
December 31, 2018
Aurobindo Pharma USA Inc
60,417 bottles units
FDA Food
Class I
Terminated
The Forest Wild Collection Dark Chocolate bar, CB15052, net wt. 1.25 oz per bar. Product is packaged in a card board box of 12 individually wrapped chocolate bars. Dream Chocolate brand, UPC on each b
December 28, 2018
Salmon River Foods Inc
3 boxes each containing 12/1.25 oz dark chocolate bars units
FDA Drug
Class II
Terminated
Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale, Goa Ind
December 26, 2018
Glenmark Pharmaceuticals Inc., USA
96,240 applicators units
FDA Drug
Class III
Terminated
LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distributed by Drug Mart-Food Fair Medina Ohio 44256 Ohm Laboratories Inc. UPC 0 93351 11270 6 NDC#:53943-123-24
December 26, 2018
Sun Pharmaceutical Industries Inc.
5040 cartons units
FDA Food
Class I
Terminated
Wild Dungeness Crab Cake; Net Weight: 12 lb - 48 x 4.0 oz. Keep Frozen Manufactured for Whole Foods Market
December 21, 2018
Southwind Foods LLC dba Great American Seafood Imports Co.
13 cases (156 lbs.) units
FDA Food
Class I
Terminated
The Chocolate Therapist, Chocolate Rx, The Purist, 72% Natural Dark Chocolate, Net Wt 2oz (57g)
December 21, 2018
Chocolate Therapist, The
448 units
FDA Food
Class I
Terminated
Dakota Specialty Milling Enhanced Flax Flour Blend, 42205, Net Wt 50 lbs. Ground Flax, Calcium Sulfate, inulin, VM 112 (vitamin mix flour enrichment containing Niacin, Iron, Vitamin B-1, Vitamin B-2,
December 21, 2018
Dakota Specialty Milling, Inc
11,750 lbs. units
FDA Food
Class I
Terminated
New & Improved RTU Donut Glaze, NET WEIGHT 2800 lb. (1270 Kg) tote, UPC Codes: 608002213109, Product Code: 4110531
December 21, 2018
Pennant Ingredients
154,000 lb. units
FDA Food
Class I
Terminated
Dakota Specialty Milling Milton's MG Premix w Enrichment 94503860, 41820, Net Wt 50 lbs. Yellow Corn, Wheat Bran, Oat Fiber, Enrichment Blend (Contains: Vitamins B1, B2, B3, B6, B12; Pantothenic Aci
December 21, 2018
Dakota Specialty Milling, Inc
92,150 lbs. units
FDA Food
Class I
Terminated
5-pound cans of unpasteurized, ready-to-eat, Dungeness crab meat, packaged in reduced oxygen metal cans that were shipped with Fresh-Check B Time Temperature Indicator (TTIs). Product was shipped fro
December 21, 2018
Bornstein Seafoods Inc
Total 1715 lbs. units
FDA Drug
Class II
Terminated
Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 212
December 21, 2018
LUPIN SOMERSET
23,460 bottles units
CPSC
Ongoing
Miles Industries Recalls Gas Fireplaces Due to Burn Hazard
December 20, 2018
Miles Industries Ltd., of Canada
About 1,000 (in addition, about 1,900 were sold in Canada) units
CPSC
Ongoing
Navien Recalls Tankless Water Heaters and Boilers Due to Risk of Carbon Monoxide Poisoning
December 20, 2018
Kyung Dong Navien Co. Ltd, South Korea
About 3,400 units
FDA Food
Class II
Terminated
Diced Onions, packaged in vacuum sealed clear polybags, 5 pounds each, four packages per case. Product is sold under brand name Apple Foods. This product distributed with the words "Keep Refrigera
December 20, 2018
Apple Foods, Inc.
162/5 lb. bags units
FDA Food
Class I
Terminated
Nutty Choco Pop, 10 oz. bag. Sold in the following configurations: Item #101, Gift Box (contains 1-10 oz. bag), Item #1728 Holiday Crowd Pleaser (contains 5-10 oz. bags), and #9676 Crowd Pleaser (c
December 20, 2018
Funky Chunky LLC
2214 units units
FDA Food
Class II
Terminated
Diced Carrots, packaged in vacuum sealed clear polybags, 5 pounds each, four packages per case. Product is sold under brand name Apple Foods. Carrot Sticks, packaged in vacuum sealed clear polybag
December 20, 2018
Apple Foods, Inc.
79/5 lb. bags Diced Carrots; 244/5 lb. bags of Carrot Sticks units
FDA Food
Class II
Terminated
Coleslaw (shredded white cabbage), packaged in vacuum sealed clear polybags, 5 pounds each, four packages per case. Product is sold under brand name Apple Foods. This product distributed with the
December 20, 2018
Apple Foods, Inc.
72/5 lb. bags units
FDA Food
Class II
Terminated
Diced Celery, packaged in vacuum sealed clear polybags, 5 pounds each, four packages per case. Product is sold under brand name Apple Foods. Celery Sticks, packaged in vacuum sealed clear polybags
December 20, 2018
Apple Foods, Inc.
73/5 lb. bags of Diced Celery and 122/5 lb. bags of Celery Sticks units
FDA Food
Class II
Terminated
Country Salad is a mixed product and it consists of Iceberg Lettuce, Romaine Lettuce, Shredded Carrots, Shredded Cabbage, and Sliced Radish. Products are cut or diced raw vegetables, packaged in va
December 20, 2018
Apple Foods, Inc.
488/5 lb. bags units
FDA Drug
Class I
Terminated
Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); Rx only, Manufactured for: Lupin Pharmaceuticals, In
December 20, 2018
Lupin Pharmaceuticals Inc.
a) 12,000 vials; b) 11,763 boxes units
FDA Drug
Class I
Terminated
Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, In
December 20, 2018
Lupin Pharmaceuticals Inc.
a) 8,000 vials; b) 32,045 boxes units
FDA Drug
Class II
Ongoing
LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
December 20, 2018
Torrent Pharma Inc
43,416 bottles units
FDA Drug
Class I
Terminated
Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc.,
December 20, 2018
Lupin Pharmaceuticals Inc.
a) 35,000 vials; b) 112,641 boxes units
FDA Drug
Class III
Terminated
COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL, NDC: 17478-605-10
December 20, 2018
Akorn, Inc.
30,794 bottles units
FDA Drug
Class II
Ongoing
LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceutica
December 20, 2018
Torrent Pharma Inc
83,016 bottles units
FDA Drug
Class I
Terminated
Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 2
December 20, 2018
Lupin Pharmaceuticals Inc.
3,792 boxes units
FDA Drug
Class II
Completed
OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvine, CA 92612, NDC 0023-3348-07
December 20, 2018
Allergan, PLC.
133,716 Cartons units
FDA Drug
Class II
Ongoing
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by: Torrent Pharmaceut
December 20, 2018
Torrent Pharma Inc
18,852 bottles units
FDA Drug
Class II
Ongoing
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceutic
December 20, 2018
Torrent Pharma Inc
18,780 bottles units
FDA Drug
Class III
Terminated
Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ ---- NDC 43975-256-14
December 20, 2018
Amerigen Pharmaceuticals Inc.
771 bottles units
FDA Drug
Class II
Ongoing
LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90), c) 1000-count bottle (NDC: 13668-409-10), Rx only, Manufactured by: Torrent Phar
December 20, 2018
Torrent Pharma Inc
65,832 bottles units
FDA Drug
Class III
Terminated
Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pha
December 20, 2018
Amerigen Pharmaceuticals Inc.
3552 bottles units
NHTSA
Ongoing
Loose Front Suspension Fasteners
December 20, 2018
Volkswagen Group of America, Inc.
36 units
NHTSA
Ongoing
Block Heater Cable Splice Connector May Corrode
December 20, 2018
FORD MOTOR COMPANY
410,289 units
CPSC
Ongoing
Manhattan Toy Recalls Children's Books Due to Choking Hazard
December 19, 2018
About 1,180 (in addition, about 20 were sold in Canada) units
CPSC
Ongoing
Women's Iron Complete Supplements Recalled by GNC Due to Failure to Meet Child Resistant Closure Requirement; Risk of Poisoning
December 19, 2018
Nutra Manufacturing, Inc., of Greenville, S.C. (a GNC Company)
About 756,000 units