Product Recalls in 2019

4,851 recalls issued this year

241

CPSC

1,807

FDA Food

1,788

FDA Drug

1,015

NHTSA

FDA Food Class III Terminated

Item FG 10190, Barleans Full Spectrum Hemp Extract, 60 Softgels per bottle. UPC 7 05875 80113 3. Item FG 10193, Barleans Full Spectrum Hemp Extract, 30 Softgels per bottle. UPC 7 05875 80115 7.

May 6, 2019 Barlean's Llc firm did not provide units
FDA Drug Class II Terminated

Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY 10941, NDC 54162-007-08

May 6, 2019 Geritrex, LLC 24312 units units
FDA Drug Class II Terminated

MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-918-18

May 6, 2019 Zydus Pharmaceuticals USA Inc N/A units
NHTSA Ongoing

Occupant Detection System may Misclassify

May 6, 2019 Suzuki Motor of America, Inc. 21,052 units
FDA Food Class III Terminated

Item FG 10084, Barlean s, Ultra EPA Fish Oil 1250 mg Omega-3, 60 softgels per bottle, UPC 7 05875 61005 6.

May 6, 2019 Barlean's Llc 32 bottles units
FDA Drug Class II Terminated

Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 683

May 6, 2019 Zydus Pharmaceuticals USA Inc 113,304 90-count bottles units
FDA Food Class III Terminated

Item FG 10191, Barlean s Ideal CBD Hemp Oil Softgel, 900 mg CBD, Less than 0.3% THC, 60 Softgels per bottle. UPC 7 05875 80112 6. Item FG 10194, Barlean s Ideal CBD Hemp Oil softgel, 750 mg CBD, Le

May 6, 2019 Barlean's Llc 589 bottles (FG 10191); did not provide for FG 10194 units
FDA Food Class III Terminated

Item FG 10037, Barlean s Cod Liver Oil Omega 3 EPA/DHA with Added Vitamin D, 100 softgel per bottle. UPC 7 05875 61010 0

May 6, 2019 Barlean's Llc 70 bottles units
FDA Food Class I Terminated

Biltmore, Sashimi Grade Smoked Wild Sockeye All Natural Alaskan Salmon, 4 oz. (113g)

May 6, 2019 Seven Seas International USA LLC 5410 sleeves/541 cases units
FDA Food Class III Terminated

Item FG 10116, Barlean s, Master Blend Total Omega 3.6.9 Lemonade Flavor, 90 Softgels per bottle. UPC 7 05875 10020 5.

May 6, 2019 Barlean's Llc 1943 bottles units
FDA Drug Class II Terminated

ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 NDC 68382-209-06

May 6, 2019 Zydus Pharmaceuticals USA Inc 1,425,264 30-count bottles units
FDA Drug Class II Terminated

Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.

May 6, 2019 Zydus Pharmaceuticals USA Inc 204 1000-count bottles units
FDA Drug Class II Terminated

Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC

May 6, 2019 Zydus Pharmaceuticals USA Inc 143,184 90-count bottles units
NHTSA Ongoing

Rear Clearance Lamp Visibility Blocked/FMVSS108

May 6, 2019 SUPREME CORPORATION 278 units
NHTSA Ongoing

Roof Hatch Glass may Shatter

May 6, 2019 Motor Coach Industries 75 units
FDA Food Class III Terminated

Item FG 10085, Barleans, Ultra EPA-DHA Fish Oil 1,300 mg Omega-3 Orange Flavor, 60 Softgels per bottle. UPC 7 05875 61006 3.

May 6, 2019 Barlean's Llc 229 bottles units
FDA Drug Class II Terminated

Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 6

May 6, 2019 Zydus Pharmaceuticals USA Inc 215,760 90-count bottles units
FDA Food Class III Terminated

Item FG 10089, Barlean s, Fish Oil Omega-3 EPA/DHA Orange Flavor, 100 Softgels per bottle. UPC 7 05875 61007 0. Item FG 10090, Barlean s, Fish Oil Omega-3 EPA/DHA Orange Flavor, 250 Softgels per

May 6, 2019 Barlean's Llc 1845 bottles (FG 10089); 3606 bottles (FG 10090) units
FDA Food Class III Terminated

Item FG 10083, Barlean's, Ultra DHA Fish Oil Omega-3, Lemonade Flavor, 90 softgels per bottle, UPC 7 05875 61004 9.

May 6, 2019 Barlean's Llc 3 bottles units
FDA Drug Class II Terminated

Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10

May 6, 2019 Zydus Pharmaceuticals USA Inc 3,156 1000-count bottles units
FDA Drug Class II Terminated

Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534. NDC 68382

May 6, 2019 Zydus Pharmaceuticals USA Inc 768 1000-count bottles units
FDA Food Class III Terminated

Item FG 10149, Barlean s, Omega Man, 120 Softgels per bottle, UPC 7 05875 10019 9

May 6, 2019 Barlean's Llc 1360 bottles units
FDA Drug Class II Terminated

Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08

May 6, 2019 Geritrex, LLC 1536 units units
FDA Drug Class II Terminated

MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11

May 6, 2019 Zydus Pharmaceuticals USA Inc 40872 25-count bottles units
FDA Food Class III Terminated

Item FG 10106, Barlean s, Olive Leaf Complex, 120 Softgels per bottle. UPC 7 05875 70009 2. Item FG 10107, Barlean s, Olive Leaf Complex, 60 Softgels per bottle. UPC 7 05875 0008 5.

May 6, 2019 Barlean's Llc 239 bottles (FG 10106) and 1565 bottles (FG 10107) units
FDA Drug Class II Terminated

MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-916-34

May 6, 2019 Zydus Pharmaceuticals USA Inc N/A units
FDA Drug Class II Terminated

MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01

May 6, 2019 Zydus Pharmaceuticals USA Inc 34521 100-count bottles units
FDA Drug Class I Terminated

The Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4 Capsules per packet.

May 6, 2019 Stiff Boy LLC 1000 boxes units
FDA Drug Class II Terminated

Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-2

May 6, 2019 Zydus Pharmaceuticals USA Inc 47,664 90-count bottles units
FDA Drug Class II Terminated

Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC

May 6, 2019 Zydus Pharmaceuticals USA Inc 168,330 90-count bottles units
FDA Drug Class II Terminated

MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11

May 6, 2019 Zydus Pharmaceuticals USA Inc 13,564 25-count bottles units
FDA Food Class III Terminated

Item FG 10146, Barlean s, Essential Woman, 120 count Softgels per bottle, UPC 7 05875 10013 7. Item FG 10147, Barlean s, Essential Woman, 60 count Softgels per bottle, UPC 7 05875 10009 0.

May 6, 2019 Barlean's Llc 1144 bottles (FG 10146) and 1913 bottles (FG 10147) units
FDA Drug Class II Terminated

Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanc

May 3, 2019 Heritage Pharmaceuticals, Inc. 15541 bottles units
FDA Drug Class II Terminated

Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram

May 3, 2019 Heritage Pharmaceuticals, Inc. 25220 bottles units
FDA Food Class I Terminated

Gia Russa Whole Grain Italian Unseasoned Bread Crumbs in 10 Oz Paperboard Canisters

May 3, 2019 Icco Cheese Co Inc 16, 91.25 Lbs (total) units
FDA Food Class II Terminated

Back Roads Granola: Coconut Crunch Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb

May 3, 2019 Back Roads Food Company unknown units
FDA Food Class II Terminated

Back Roads Granola: Gluten Free Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb

May 3, 2019 Back Roads Food Company unknown units
FDA Drug Class II Terminated

Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA SPECIALTY PHARMACY 24416 N. 19TH AVENUE PHOENIX, AZ 85085, NDC 42852-001-27

May 3, 2019 Avella of Deer Valley, Inc. Store 38 730 syringes units
FDA Food Class II Terminated

Back Roads Granola: Original Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb

May 3, 2019 Back Roads Food Company unknown units
FDA Food Class II Terminated

Back Roads Granola: Dark Chocolate Pecan Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb

May 3, 2019 Back Roads Food Company unknown units
FDA Drug Class II Terminated

Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kan

May 3, 2019 Heritage Pharmaceuticals, Inc. 3012 bottles units
FDA Food Class II Terminated

Back Roads Granola: Coconut Ginger Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb

May 3, 2019 Back Roads Food Company unknown units
FDA Food Class II Terminated

Back Roads Granola: Maple Pecan Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb

May 3, 2019 Back Roads Food Company unknown units
FDA Food Class II Terminated

Back Roads Granola: Ancient Grains Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb

May 3, 2019 Back Roads Food Company unknown units
NHTSA Ongoing

Brake Light May Randomly Illuminate

May 3, 2019 TAYLOR MADE AMBULANCES 17 units
FDA Food Class II Terminated

Back Roads Granola: Maple Spice Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb

May 3, 2019 Back Roads Food Company unknown units
FDA Drug Class II Terminated

Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur,

May 3, 2019 Heritage Pharmaceuticals, Inc. 3697 bottles units
FDA Drug Class II Terminated

Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram

May 3, 2019 Heritage Pharmaceuticals, Inc. 34403 bottles units
FDA Food Class II Terminated

Back Roads Granola: Nut Free Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb

May 3, 2019 Back Roads Food Company unknown units
FDA Food Class I Terminated

Gia Russa Whole Grain Italian Seasoned Bread Crumbs in 10 Oz Paperboard Canisters

May 3, 2019 Icco Cheese Co Inc 16, 91.25 Lbs (total) units