Product Recalls in 2019
4,851 recalls issued this year
241
CPSC
1,807
FDA Food
1,788
FDA Drug
1,015
NHTSA
FDA Drug
Class II
Terminated
Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-40
October 25, 2019
Novitium Pharma LLC
6660 bottles units
NHTSA
Ongoing
Service Brake Air Reservoir Not Pressure Protected
October 25, 2019
Custom Fire Apparatus, Inc.
57 units
FDA Drug
Class II
Terminated
Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-40
October 25, 2019
Novitium Pharma LLC
2718 bottles units
FDA Drug
Class II
Terminated
Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-10
October 25, 2019
Novitium Pharma LLC
12312 bottles units
NHTSA
Ongoing
Cooktop Burner Flames May Invert
October 25, 2019
KEYSTONE RV COMPANY
157 units
FDA Drug
Class I
Terminated
0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25
October 25, 2019
ICU Medical Inc
58,464 bags units
FDA Drug
Class II
Terminated
Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20
October 25, 2019
Novitium Pharma LLC
19560 bottles units
NHTSA
Ongoing
Software Error May Cause Unintended Braking
October 25, 2019
GENERAL MOTORS LLC
652,967 units
NHTSA
Ongoing
VCU May Activate the Anti-Roll Back
October 25, 2019
BLUE BIRD BODY COMPANY
83 units
NHTSA
Ongoing
Seat Belt Webbing May Detach From Anchor
October 25, 2019
FORD MOTOR COMPANY
366 units
FDA Drug
Class I
Terminated
LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03
October 25, 2019
ICU Medical Inc
389,808 bags units
NHTSA
Ongoing
Safety Chains may be Too Short
October 24, 2019
Southern Pride Distributing LLC
19 units
FDA Food
Class II
Terminated
Taspen's Organics Breathe Easy Herbal Tincture Dietary Supplement, sold in 1 oz, 2 oz, and 4 oz amber glass bottles with dropper.
October 24, 2019
Green Water, LLC
197 units units
NHTSA
Ongoing
Front Tires May Be Damaged
October 24, 2019
Chrysler (FCA US LLC)
173 units
NHTSA
Ongoing
Seat Strikers May Fail In Crash
October 24, 2019
Chrysler (FCA US LLC)
30,354 units
NHTSA
Ongoing
Improperly Installed Interior Trunk Release Cable
October 24, 2019
BMW OF NORTH AMERICA, LLC
325 units
FDA Food
Class II
Terminated
Dragonfly Botanicals Full spectrum Breathe Deep 1000mg/oz Dietary Supplement, sold in 0.5 oz, 1 oz, 2 oz, and 4 oz amber glass bottles with dropper.
October 24, 2019
Green Water, LLC
268 units units
FDA Food
Class II
Terminated
Taspen's Organics Respiratory Tea, sold in 2 oz packages
October 24, 2019
Green Water, LLC
69 units units
NHTSA
Ongoing
EGR Cooler May Crack and Cause Fire
October 24, 2019
Chrysler (FCA US LLC)
107,980 units
FDA Food
Class I
Terminated
North Bay Produce brand McIntosh, Honeycrisp, Jonathan, Fuji, Jonamac and Red Delicious apples sold in 2 lbs and 3 lbs plastic bags, white paper quarter peck bags, half peck clear plastic tote bags,
October 24, 2019
NORTH BAY PRODUCE INC.
2,297 cases and 46 bulk bins units
NHTSA
Ongoing
Steering Gear may Loosen
October 24, 2019
VOLVO TRUCKS NORTH AMERICA
2,287 units
FDA Drug
Class II
Terminated
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Care One: 41520-392-09; NDC CVS Health: 59779-540-09; NDC Family Wellness: 55319-852-09; NDC Good
October 23, 2019
Perrigo Company PLC
FDA Drug
Class II
Terminated
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-47
October 23, 2019
Perrigo Company PLC
FDA Drug
Class II
Terminated
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-01; NDC Berkley Jensen: 68391-852-56; NDC: CVS Health: 59779-540-01; NDC DG
October 23, 2019
Perrigo Company PLC
FDA Food
Class II
Terminated
Boulder Chocolate Maple Pear Brandy Flambe Truffles, 2.6 oz, packed in plastic box, 4/pkg., 6 pkgs/case
October 23, 2019
Lift Chocolate, LLC
120 units units
NHTSA
Ongoing
Cooktop LP Gas Line May Melt and Cause Fire
October 23, 2019
FOREST RIVER, INC.
41 units
FDA Drug
Class II
Terminated
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per bottle. [Brand, NDC] NDC DG Health: 55910-852-71; NDC Good Neighbor Pharmacy: 46122-224-71; NDC Good Sense: 0113-0852-71;
October 23, 2019
Perrigo Company PLC
FDA Drug
Class II
Terminated
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC G
October 23, 2019
Perrigo Company PLC
FDA Drug
Class II
Terminated
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Care One: 41520-609-62; NDC CVS Health: 59779-950-62; NDC DG Health: 55910-423-62; NDC
October 23, 2019
Perrigo Company PLC
FDA Drug
Class II
Terminated
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-01
October 23, 2019
Perrigo Company PLC
FDA Drug
Class II
Terminated
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58
October 23, 2019
Perrigo Company PLC
FDA Drug
Class II
Terminated
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82; NDC CVS Health: 59779-540-82; NDC HEB: 37808-507-82; NDC Signature Ca
October 23, 2019
Perrigo Company PLC
FDA Drug
Class II
Terminated
Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05
October 23, 2019
Mylan Pharmaceuticals Inc.
5,760 bottles units
FDA Drug
Class II
Terminated
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75
October 23, 2019
Perrigo Company PLC
FDA Drug
Class II
Terminated
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per bottle. [NDC: Brand] NDC Basic Care: 0113-7876-27; NDC CVS Health: 69842-293-27; NDC Leader: 70000-0375-2; NDC Up & Up: 11
October 23, 2019
Perrigo Company PLC
FDA Drug
Class II
Terminated
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608-75; NDC Up & Up: 11673-023-75
October 23, 2019
Perrigo Company PLC
FDA Drug
Class II
Terminated
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Being Well: 46994-852-62; NDC Care One 41520-392-02; NDC CVS Health: 59779-540-02; NDC DG Health:
October 23, 2019
Perrigo Company PLC
FDA Food
Class I
Terminated
Salmon Misozuke; Seasoned Atlantic Salmon Product # 51104; Not For retail 10 pkg/5 pc(2.75 lbs./1.25 kg)/case Distributed by: Azuma Foods International, Inc., U.S.A. Hayward, CA 64545 Produc
October 23, 2019
Azuma Foods International Inc USA
38 cases units
FDA Food
Class I
Terminated
Teriyaki Grilled Calamari, (Grilled Squid with Teriyaki Sauce) Product # 51100; not for retail 10pkg/2.2 lbs. (1kg)/case Distributed by: Azuma Foods International, Inc., USA, Hayward, CA 94545
October 23, 2019
Azuma Foods International Inc USA
96 cases units
FDA Food
Class I
Terminated
Frozen Saba Misozuke; (seasoned Mackerel) Product # 51108, Not for Retail 12 pkg/5pc(1.76lbs./800g)/ case Distributed by: Azuma Foods International, Inc., U.S.A. Hayward, CA Product of Thailan
October 23, 2019
Azuma Foods International Inc USA
8 cases units
FDA Drug
Class II
Terminated
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [NDC: Brand] NDC Good Sense:0113-0852-51; NDC Walgreens 0363-0852-51
October 23, 2019
Perrigo Company PLC
FDA Drug
Class II
Terminated
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-293-65; NDC Equaline 41163-931-65; NDC Family Wellness: 55319-876-65; NDC Good S
October 23, 2019
Perrigo Company PLC
FDA Drug
Class II
Terminated
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2; NDC Major: 0904-6715-52; NDC Meijer: 41250-252-72; NDC Sunmark: 49348-
October 23, 2019
Perrigo Company PLC
FDA Drug
Class II
Terminated
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per bottle. [NDC: Brand] NDC CVS Health.: 69842-293-06
October 23, 2019
Perrigo Company PLC
FDA Food
Class I
Terminated
Parivar brand Dry Dates (Kharek) Net Wt.7 oz. (200 g) and 14 oz. (400 g) Product of India Batch No. 125/BIBT
October 23, 2019
DILIP CERAMICS DBA SHIVAM DISTRIBUT
15 cases/ 20 packages per case (300 packages) units
FDA Food
Class I
Terminated
Frozen Ika Popo (Sugata Yaki); Product # 51106 16 pkg/0.46 lbs (210g)/case
October 23, 2019
Azuma Foods International Inc USA
8 cases units
NHTSA
Ongoing
Helmets May Not Protect Occupant/FMVSS 218
October 22, 2019
H&H Sports Protection
4,218 units
FDA Drug
Class II
Ongoing
Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 67751-151-01.
October 22, 2019
Sanofi-Aventis U.S. LLC
FDA Drug
Class II
Ongoing
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 67751-152-01 67751-152-02
October 22, 2019
Sanofi-Aventis U.S. LLC
FDA Drug
Class II
Ongoing
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167-0300-0, 41167-0300-1, 41167-0300-3, 41167-0300-5, 4116
October 22, 2019
Sanofi-Aventis U.S. LLC