Recall archive

All consumer recall records

Actionable records answer all three decision questions. Limited records remain available and clearly identify missing official information.

Actionable recallConsumer Products

Bayer 6 mL Size Afrin Original Nasal Spray Bottles

The 6 mL nasal sprays contain an imidazoline, which must be in child-resistant packaging or meet the labeling requirements for non-complying packaging, as required by the Poison Prevention Packaging Act. The 6 mL nasal spray's packaging is not child-resista...

AffectedThis recall involves unexpired Travel Size Afrin® Original Nasal Spray 6 mL bottles, with Lot numbers 230361, 240822,...
RiskThe 6 mL nasal sprays contain an imidazoline, which must be in child-resistant packaging or meet the labeling require...
ActionConsumers should immediately secure the recalled bottles out of sight and reach of children and go to the webform pos...
Recalled Afrin® 6mL Size Original Nasal Spray Bottles (Front of Bottle)
Actionable recallConsumer Products

Build-A-Bear Workshop Heartwarming Hugs Bears

The zipper slider on the side pouch can detach, posing a risk of serious injury or death from choking hazard to children.

AffectedThis recall involves the Heartwarming Hugs weighted plush bear with model number 034464. It has a side pouch containi...
RiskThe zipper slider on the side pouch can detach, posing a risk of serious injury or death from choking hazard to child...
ActionConsumers should immediately stop using the recalled Heartwarming Hugs Bear and return it to a local Build-A-Bear Wor...
Recalled Heartwarming Hugs Bear
Actionable recallConsumer Products

CBC Group Stephan Baby Boo Bunnie and Friends Children's Toys

The toys' plastic cube can break into small parts or sharp edges, posing a risk of serious injury from choking and laceration hazards.

AffectedThis recall involves all Stephan Baby-branded Boo Bunnie and Friends children's toys. The recalled toys consist of a...
RiskThe toys' plastic cube can break into small parts or sharp edges, posing a risk of serious injury from choking and la...
ActionConsumers should immediately stop using the recalled toys' plastic cube and take it away from children. Consumers sho...
Recalled Stephan Baby Boo Bunnie and Friends Children's Toys
Actionable recallConsumer Products

Earthtec Pool Drain Covers Recalled

The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing entrapment and drowning hazards to swimmers and bathers.

AffectedThis recall involves Earthtec pool drain covers that are sold for use in swimming pools. The pool drain covers are 7...
RiskThe recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safet...
ActionPool owners, pool operators and consumers should stop using pools with the recalled pool drain covers immediately. To...
Recalled Earthtec 7 3/8-inch Pool Drain Cover (front view)
Actionable recallConsumer Products

Malker Bicycle Light Sets Recalled

The recalled bicycle lights violate the mandatory standard for consumer products with button cell and coin batteries because they contain button cell batteries that can be accessed easily by children, posing an ingestion hazard. Additionally, the bicycle li...

AffectedThis recall involves Malker Bicycle Light Sets. The bicycle lights were sold in 4- or 8-pack sizes. The products made...
RiskThe recalled bicycle lights violate the mandatory standard for consumer products with button cell and coin batteries...
ActionConsumers should stop using the recalled bicycle lights immediately and contact MalkerDirect for a full refund. Consu...
Recalled Malker Bicycle Light Sets in Eight-Pack
Actionable recallConsumer Products

Pressure Washers Recalled

The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI), posing a serious risk of injury or death from shock and electrocution hazards.

AffectedThis recall involves DGIVOVO US-branded pressure washers. The recalled, electric pressure washers are red, green or b...
RiskThe recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI), posing a serious risk of inju...
ActionConsumers should immediately stop using the recalled pressure washers and contact DGIVOVO US for a free replacement p...
Recalled DGIVOVO US Electric Pressure Washer
Actionable recallConsumer Products

Qumeney Bicycle Light Sets Recalled

The recalled bicycle lights violate the mandatory standard for consumer products with button cell and coin batteries because they contain button cell batteries that can be accessed easily by children, posing an ingestion hazard. Additionally, the bicycle li...

AffectedThis recall involves Qumeney Bicycle Light Sets, models: BL-01 and BL-02. The bicycle lights are encased in silicone...
RiskThe recalled bicycle lights violate the mandatory standard for consumer products with button cell and coin batteries...
ActionConsumers should stop using the recalled bicycle lights immediately and contact Smfanlus for a full refund. Consumers...
Recalled Qumeney Bicycle Light Sets – 24-Pack
Actionable recallConsumer Products

Residential Elevators Elevator StrikeLock Hoistway Door Locking Device

The elevator's StrikeLock hoistway door locking device can allow the elevator cab to move with a landing door open, posing a risk of serious injury or death due to fall and injury hazards.

AffectedThis recall involves the StrikeLock hoistway door locking device, used to secure a residential elevator hoistway land...
RiskThe elevator's StrikeLock hoistway door locking device can allow the elevator cab to move with a landing door open, p...
ActionConsumers should immediately stop using the residential elevator systems where StrikeLock hoistway door locking devic...
Recalled StrikeLock Door Locking Device
Actionable recallConsumer Products

Segmart 4-Drawer Dressers Recalled

The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.

AffectedThis recall involves Segmart 4-Drawer Dressers. The recalled dressers are made of particle board and were sold in bla...
RiskThe recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that...
ActionConsumers should immediately stop using the recalled dressers if they are not anchored to the wall and place them in...
Recalled Black Segmart 4-Drawer Dresser (front)
Actionable recallConsumer Products

Thermos 8.2 Million Stainless King Food Jars and Bottles

If perishable food or beverages are stored in the container for an extended period of time, the stopper can forcefully eject when opened, which can result in serious impact injury and laceration hazards to the consumer.

AffectedThis recall involves Thermos Stainless King Food Jars with model numbers SK3000 and SK3020, manufactured before July...
RiskIf perishable food or beverages are stored in the container for an extended period of time, the stopper can forcefull...
ActionConsumers should stop using the recalled Food Jars and Bottles immediately and contact Thermos to receive a free repl...
Recalled Thermos 16-oz Stainless King Food Jar (SK3000), 40-oz Sportsman Food & Beverage Bottle (SK3010), and 24-oz Stainless King Food Jar (SK3020)
Limited official informationFood

Bombay Kitchen brand Tikka Sev

Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40

AffectedBombay Kitchen brand Tikka Sev; Net Wt 9oz (255g); INGREDIENTS: Chickpea Flour, Water, Non-GMO Expeller Pressed Canol...
RiskProduct(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60

Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin

AffectedClaravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister pa...
RiskFailed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

AffectedDEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, ND...
RiskLack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01

CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.

AffectedFurosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 070...
RiskCGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distrib...

Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

AffectedOmega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only,...
RiskFailed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Dry...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Pis...

Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."

AffectedPantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharma...
RiskDiscoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighte...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth...

Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the b...

AffectedPremier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Ro...
RiskLabeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 i...
ActionNot available

Missing from associated official evidence: action.

Limited official informationFood

SALUTE SEASONINGS

Product may be contaminated with Salmonella.

AffectedSALUTE SEASONINGS; Ground All Spice; Net Wt 16oz; Unistel Industries 650 Blossom Road Rochester, NY 14610; UPC: 7 692...
RiskProduct may be contaminated with Salmonella.
ActionNot available

Missing from associated official evidence: action.

Limited official informationFood

Spice Powder, 4 oz, Plastic Bag

Lead level was higher than NYSAGM Standard.

AffectedSpice Powder, 4 oz, Plastic Bag
RiskLead level was higher than NYSAGM Standard.
ActionNot available

Missing from associated official evidence: action.

Actionable recallConsumer Products

32 Degrees Heated Socks

When worn during high-intensity activities that generate a combination of heat, excessive friction, moisture and pressure, the socks can pose an injury hazard including burns.

AffectedThis recall involves heated socks sold in three sizes (medium, large, extra large), all in the color black. "32° HEAT...
RiskWhen worn during high-intensity activities that generate a combination of heat, excessive friction, moisture and pres...
ActionConsumers should immediately stop using the heated socks and return them to Costco for a full refund.
Recalled 32 Degrees Heated Socks with rechargeable battery pack, user manual and packaging