Product Recalls in 2021

3,955 recalls issued this year

219

CPSC

1,491

FDA Food

1,152

FDA Drug

1,093

NHTSA

FDA Drug Class II Terminated

BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1235-01

December 6, 2021 Edge Pharma, LLC 1173 jars units
FDA Drug Class II Terminated

Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules

December 6, 2021 Edge Pharma, LLC 2568 syringes units
FDA Drug Class II Terminated

Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1549-05

December 6, 2021 Edge Pharma, LLC 160 syringes units
FDA Drug Class II Terminated

Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 054

December 6, 2021 Edge Pharma, LLC 80 droppers units
FDA Drug Class II Terminated

Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured

December 6, 2021 Medique Products 3,260,400 tablets units
FDA Drug Class III Terminated

CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and two bottles of

December 3, 2021 Dental Alliance Holdings LLC 225 single tube of lot 31217 and 99 single tube of 312108 units
FDA Drug Class III Terminated

CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and three bottles

December 3, 2021 Dental Alliance Holdings LLC 180 single tube of lot 272109 and 180 single tube count of lot 272110 units
NHTSA Ongoing

Driveshaft May Fail

December 3, 2021 HONDA (AMERICAN HONDA MOTOR CO.) 279 units
FDA Drug Class II Terminated

B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409

December 3, 2021 Valgene Incorporated dba Cape Drugs 12 vials units
FDA Drug Class III Terminated

CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and one bottle of CariFre

December 3, 2021 Dental Alliance Holdings LLC 3 single tubes of lot 192107 and 3 single tubes of 192108 units
FDA Drug Class II Terminated

Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409

December 3, 2021 Valgene Incorporated dba Cape Drugs 27 vials units
FDA Food Class I Terminated

BUBS Naturals Fountain of Youth Formula; Collagen Protein; Support for Hair, Skin & Nails; Biotin, Antioxidant, Vitamin C; Maqui Berry Net Wt. 10.16 oz. (288 g)

December 3, 2021 Slayer Forever, LLC dba BUBS Naturals 12,774 units units
FDA Drug Class III Terminated

Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34

December 3, 2021 Akorn, Inc. 8184 bottles units
FDA Drug Class III Terminated

CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 Distributed in 12-pk/cases

December 3, 2021 Dental Alliance Holdings LLC 6612 individual tubes for the 12 pack and 15 individual tubes for the 2 oz. of Lot 142017 units
FDA Drug Class III Terminated

CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and six boxes of 4

December 3, 2021 Dental Alliance Holdings LLC 90 single tubes of 352110 and 315 single tubes of 352111 units
FDA Drug Class I Terminated

Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2

December 3, 2021 Gilead Sciences, Inc. 53,473 vials units
FDA Drug Class III Terminated

CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.

December 3, 2021 Dental Alliance Holdings LLC 8 single tubes of lot 492106 and 50 single tubes of lot 492107 units
FDA Drug Class III Terminated

Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30

December 3, 2021 Akorn, Inc. 10,836 bottles units
FDA Drug Class III Terminated

CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.

December 3, 2021 Dental Alliance Holdings LLC 360 individual tubes of lot 142017. units
NHTSA Ongoing

Bolt Fasteners on Rear Step Not Properly Tightened

December 2, 2021 Daimler Vans USA, LLC 30 units
NHTSA Ongoing

Inoperable Headlights and/or Taillights

December 2, 2021 HYUNDAI MOTOR AMERICA 12 units
NHTSA Ongoing

Loose Foam in Child Seat May Become Choking Hazard

December 2, 2021 Clek, Inc. 150,599 units
NHTSA Ongoing

Reduced Braking Performance

December 2, 2021 Kia Motors America 87 units
NHTSA Ongoing

Retaining Ring On Air Suspension Struts May Loosen

December 2, 2021 Volkswagen Group of America, Inc. 10 units
FDA Drug Class II Terminated

Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 0792

December 2, 2021 Torrent Pharma Inc 15,336 Bottles units
NHTSA Ongoing

Fuel Tubes May Crack and Leak Fuel

December 2, 2021 CUMMINS, INC. 10,938 units
NHTSA Ongoing

Child Seat Canopy Support May Pose Choking Hazard

December 2, 2021 Clek, Inc. 5,504 units
NHTSA Ongoing

Reduced Braking Performance

December 2, 2021 HYUNDAI MOTOR AMERICA 76 units
FDA Food Class II Terminated

Livia One Organic Daily Topical Spray Probiotics; 4 oz. (120 ml) UPC: 0 30915 10710 5 Recommended use: Topical: Spray affected area 2-5 times daily as needed. Ingredients: Proprietary probi

December 1, 2021 Livia Global 571 bottles units
CPSC Ongoing

Halo Recalls Promotional Children's Projector Flashlights Due to Button Battery Ingestion and Choking Hazards

December 1, 2021 About 82,500 units
CPSC Ongoing

E-filliate Recalls DEWALT Wireless Earphones Due to Burn and Fire Hazards

December 1, 2021 About 301,800 units
NHTSA Ongoing

Fender Liner May Damage Brake Hose

December 1, 2021 Daimler Vans USA, LLC 98 units
FDA Food Class II Terminated

Livia One Organic Daily Liquid Probiotics; 2 oz. (59 ml) and 4 oz. (120 ml) UPC: 0 30915 10711 2 - 2 oz. 0 30915 10716 7 - 4 oz. Recommended use: Internal: Adults 4 droppers full daily

December 1, 2021 Livia Global 1067 x 2 oz. bottles, 384 x 4 oz. bottles units
NHTSA Ongoing

Rear Axle Drive Pinion May Fracture

December 1, 2021 Meritor, Inc. 98 units
NHTSA Ongoing

Improperly Heat-Treated Tie Rods May Fail

December 1, 2021 TENNECO AUTOMOTIVE 1,306 units
FDA Food Class III Terminated

Morton Iodized Salt, Net Wt. 26 oz (1 LB 10 OZ) 737 g, Morton Salt, Inc. Chicago, IL 60606

December 1, 2021 MORTON SALT INC 16,920 canisters units
FDA Drug Class III Terminated

Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. Manufactured for: Torrent Pharma Inc

December 1, 2021 Torrent Pharma Inc 27,312 Bottles units
FDA Food Class II Terminated

Livia One Organic Probiotic Nasal Spray; 1 oz. (30 ml) UPC: 0 30915 10719 8 Suggested use: Adult - 102 pumps in each nostril as needed 1-3 times per day; Children 4-12 years : 1/4-1/2 pump in

December 1, 2021 Livia Global 1130 x 1 oz. bottles units
FDA Drug Class I Ongoing

Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation

November 30, 2021 Teligent Pharma, Inc. 6,816 bottles units
NHTSA Ongoing

Infotainment System May Cause Driver Distraction

November 30, 2021 MERCEDES-BENZ USA, LLC. 227 units
FDA Food Class II Terminated

Giant Eagle, Diced Green Peppers, 10 oz. poly bags and 22# cases, also poly bags and cartons, 12/10 oz. bags per case and bulk 22 lbs. bags

November 30, 2021 Frozen Food Development 20,825 lbs. units
FDA Food Class III Terminated

Mother's Milk Bank of North Texas 817-810-0071 Pasteurized Donor Human milk Volume: 100mL 1.00 g/dL Protein packaged in sterile BPA free plastic bottle

November 30, 2021 MOTHERS MILK BANK OF NORTH TEXAS 54 bottle units
NHTSA Ongoing

Tire Belt Separation

November 30, 2021 Sailun Tire Americas, Inc. 84,351 units
FDA Food Class II Terminated

DoctoRx's Optimal Formula, Dry Eye Formula, Ocular Support Softgel, 60 Softgels/Dietary Supplement

November 30, 2021 Golden Lab LLC 13,079 units units
FDA Drug Class II Ongoing

Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation

November 30, 2021 Teligent Pharma, Inc. 7,176 bottles units
NHTSA Ongoing

Hood May Open While Driving

November 30, 2021 HONDA (AMERICAN HONDA MOTOR CO.) 724,826 units
FDA Drug Class I Terminated

Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Technology, Inc., 7026 Discovery Drive, Chattanooga, TN 37416

November 30, 2021 Aroma Release Technologies Inc 37 55-gallon drums units
FDA Drug Class II Terminated

5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66

November 30, 2021 Pfizer Inc. 765 bags units
FDA Drug Class II Ongoing

Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01

November 29, 2021 Preferred Pharmaceuticals, Inc 72 bottles units
FDA Drug Class II Terminated

Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42

November 29, 2021 Denver Solutions, LLC DBA Leiters Health 1440 vials units