Recall archive

All consumer recall records

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

Limited official informationFood

Farm Rich Pizza Cheese Crunchers

May contain metal pieces

AffectedFarm Rich Pizza Cheese Crunchers
RiskMay contain metal pieces
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100

A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific misuse circumstances potentially allow human access to infrared laser light levels in excess of th...

AffectedFresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100
RiskA defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationDrugs

Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1),...

Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.

AffectedGas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (U...
RiskChemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the...
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc...

Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.

AffectedGSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban...
RiskFailed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Halyard, Towel Six Pack. Kit Code: AMTS70-01.

Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

AffectedHalyard, Towel Six Pack. Kit Code: AMTS70-01.; Halyard, Pain Pack. Kit Code: AMPK48-01.; plus 2 additional official v...
RiskInadvertent distribution of sealed pouches that had not undergone validated sterilization.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationFood

HH Fresh Trading Corp. (branded) ENOKI MUSHROOM

Imported Enoki Mushrooms tested positive for Listeria Monocytogenes.

AffectedHH Fresh Trading Corp. (branded) ENOKI MUSHROOM; Premium Quality; Net WT/ Poids Net 150g(5.29oz) Distributed by HH Fr...
RiskImported Enoki Mushrooms tested positive for Listeria Monocytogenes.
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Mahurkar Elite PASS Trays

The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.

AffectedMahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Ext...
RiskThe Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
ActionNot available

Missing from associated official evidence: action.

Limited official informationFood

Marquesita de Chocolate y Vainilla [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and rigid plas...

Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).

AffectedMarquesita de Chocolate y Vainilla [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transp...
RiskUndeclared colors (Yellow #5, Yellow #6, and/or Red #40).
ActionNot available

Missing from associated official evidence: action.

Limited official informationDrugs

Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDI...

Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis

AffectedMinocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Lab...
RiskFailed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolut...
ActionNot available

Missing from associated official evidence: action.

Limited official informationFood

MMB of Louisiana Pasteurized Donor Human Milk, Volume: 3 oz, Cal/Oz: 19, 0.9 g/dL Protein, packaged in a clear plastic bottle with white...

Potential physical contamination: dark spot was noticed on the bottom of container.

AffectedMMB of Louisiana Pasteurized Donor Human Milk, Volume: 3 oz, Cal/Oz: 19, 0.9 g/dL Protein, packaged in a clear plasti...
RiskPotential physical contamination: dark spot was noticed on the bottom of container.
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElastic Compression Staple...

Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.

AffectedNeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElasti...
RiskDue to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
ActionNot available

Missing from associated official evidence: action.

Limited official informationFood

NEURO NOURISH dietary supplement

Premature lipid oxidation causing quality issue potentially causing product to have an off odor and bitter taste.

AffectedNEURO NOURISH dietary supplement; 6-IN-1 PREBIOTIC, PROBIOTIC, VITAMIN, MINERAL, FATTY ACID, AND ANTIOXIDANT NUTRITIO...
RiskPremature lipid oxidation causing quality issue potentially causing product to have an off odor and bitter taste.
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

NexxZr T Multi A3.5 W98-16mm, REF: 745451

Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.

AffectedNexxZr T Multi A3.5 W98-16mm, REF: 745451
RiskYttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationDrugs

Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit...

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

AffectedPrimidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Or...
RiskCross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an iss...
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320

Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.

AffectedProduct Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320; Product Name: MIC Safety Pe...
RiskLidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile ki...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationPatient-Relevant Medical Devices

SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02

Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with...

AffectedSD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 202...
RiskNatus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four...
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationFood

Taro Cakes UPC CODE #652565100055

Undeclared Egg Allergen

AffectedTaro Cakes UPC CODE #652565100055
RiskUndeclared Egg Allergen
ActionNot available

Missing from associated official evidence: action.

Limited official informationPatient-Relevant Medical Devices

TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM

An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.

AffectedTDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 9...
RiskAn increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
ActionNot available

Missing from associated official evidence: action, consumer scope.

Limited official informationFood

WeiKFiELD Custard Powder Kesar Pista, Net Wt. 300g (10.6 OZ.), Poly Jar , 24 units per outer case.

The ingredient, Pista, currently declared on our label should be corrected to the standard American nomenclature, Pistachio.

AffectedWeiKFiELD Custard Powder Kesar Pista, Net Wt. 300g (10.6 OZ.), Poly Jar , 24 units per outer case.
RiskThe ingredient, Pista, currently declared on our label should be corrected to the standard American nomenclature, Pis...
ActionNot available

Missing from associated official evidence: action.

Actionable recallConsumer Products

7-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 standards as required by the STURDY...

AffectedThis recall involves Hasuit 7-Drawer Dressers. The recalled dressers have seven drawers, are made of wood and come in...
RiskThe recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that...
ActionConsumers should stop using the recalled dressers immediately if they are not anchored to the wall and place them in...
Recalled Hasuit 7-Drawer Dresser (front)
Actionable recallConsumer Products

Arctic Zone Titan Pro Coolers Recalled

The recalled coolers' latch magnet can detach, posing risk of serious injury or death from a choking hazard.

AffectedThis recall involves Arctic Zone Titan Pro 40 can-capacity, iceless coolers. The rectangular coolers were sold in bla...
RiskThe recalled coolers' latch magnet can detach, posing risk of serious injury or death from a choking hazard.
ActionConsumers should stop using the coolers immediately and contact California Innovations for a free replacement latch,...
Recalled Arctic Zone Titan Pro Cooler – brown, 40-can capacity