Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

276–300 of 2738

LowFDA (Food)·F-0591-2023·2023-03-22
Cafe' Intermezzo Chocolate Peanut Butter Cheesecake Recalled for Missing Sub-Ingredient Information
Epic Baking is recalling 134 units of Cafe' Intermezzo Chocolate Peanut Butter Cup Cheesecake distributed to Georgia and Tennessee because the firm failed to list sub-ingredients on the label.
Product
Cafe' Intermezzo Chocolate Peanut Butter Cup Cheesecake 6.5 lbs Ingredients: Cream Cheese, Eggs, Sugar, Chocolate Ganache (Chocolate Chips, Heavy Cream), Peanut Butter, Graham Cracker Crust (Graham Cracker Crumbs, Butter Sugar, Vanilla Extract, Cinnamon), Reese's Cups, Vanilla…
Category
Food
Distribution
2 states
LowFDA (Drugs)·D-0351-2023·2023-03-08
Avicel PH-200 pharmaceutical excipient recalled for failed conductivity specification
DuPont is recalling Avicel PH-200, a pharmaceutical excipient, because test results showed conductivity out of specification. No illnesses or injuries have been reported.
Product
Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1059-2023·2023-02-15
Face Masks Packaged in Incorrect Dispenser Boxes with Mismatched Labeling
73 cases of FLUIDSHIELD 3 procedure masks were placed in dispenser boxes labeled for masks with ties, when the actual masks have ear loops. Distributed to IL, NC, NY, OH, and PA.
Product
FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Product Code 47147
Category
Medical Device
Distribution
5 states
LowFDA (Devices)·Z-0402-2023·2022-12-14
Medical Device Recall: Missing Instructions for Bipolar Surgical Forceps
CareFusion bipolar forceps recalled because the provided instructions are missing critical information about power supply interface and cleaning procedures. No injuries reported.
Product
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS,1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5018
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0070-2023·2022-11-30
Phenytoin Sodium Injection Recalled for Missing Vial Barcode
Acella Pharmaceuticals is recalling Phenytoin Sodium Injection because the primary vial label is missing a barcode. The recall affects 637 cartons distributed nationwide.
Product
PHENYTOIN SODIUM — PHENYTOIN SODIUM (PHENYTOIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0069-2023·2022-11-30
Phenytoin Sodium Injection Recalled for Missing Barcode on Vial Label
Acella Pharmaceuticals is recalling Phenytoin Sodium Injection due to missing barcodes on vial labels. The recall affects 574 cartons distributed nationwide.
Product
PHENYTOIN SODIUM — PHENYTOIN SODIUM (PHENYTOIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0202-2023·2022-11-23
Urological Irrigation Kit Recalled for Illegible Barcode Labels
Canadian Hospital Specialties is recalling MED-RX Urological Cysto/Bladder Irrigation Sets with illegible barcodes that prevent scanning. About 9,100 units distributed in the US are affected.
Product
MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0132-2023·2022-11-02
Vortex MP Port Titanium Recalled for Missing Printed Instructions
Angiodynamics is recalling 11 Vortex MP Port Titanium implantable ports because printed Instructions for Use were not shipped with the devices. Missing instructions could lead to improper implantation or post-operative care.
Product
Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0006-2023·2022-10-12
Antibacterial Hand Wash Recalled for Incorrect Scent Label
Woodbine Products is recalling FOAMFRESH DYE FREE ANTIBACTERIAL HAND WASH due to incorrect scent information on the label. The affected lots VDAF017 and VDAF018 were distributed in North Carolina, and no illnesses have been reported.
Product
FOAMFRESH DYE FREE ANTIBACTERIAL HAND WASH — FOAMFRESH DYE FREE ANTIBACTERIAL HAND WASH (CHLOROXYLENOL)
Category
Drug
Distribution
1 state
LowFDA (Drugs)·D-1551-2022·2022-10-12
Tranexamic Acid Injection Recalled for Metal Particulate Matter
AuroMedics Pharma LLC is recalling one lot of Tranexamic Acid Injection due to the presence of metal particles found in a vial. The affected product was distributed nationwide.
Product
TRANEXAMIC ACID — TRANEXAMIC ACID (TRANEXAMIC ACID)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Food)·F-0004-2023·2022-10-12
Fila Manila Coconut Jam recalled for undeclared gluten
Fila Manila Coconut Jam (12 oz, UPC 860003619353) is being recalled because it contains undeclared gluten. Consumers with gluten sensitivity should not consume the product.
Product
Fila Manila Coconut Jam NET WT. 12 OZ (340g) UPC:860003619353
Category
Food
Distribution
2 states
LowFDA (Devices)·Z-1798-2022·2022-10-05
AquaGuard Wound Dressing Recall Due to Facility Temperature Excursions
TIDI Products AquaGuard wound dressings received June–September 2021 were exposed to elevated storage temperatures that may have impacted product effectiveness. The FDA states adverse health consequences are unlikely.
Product
a. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR 7X7 (5/PK) 9CENCO Catalog #68751510104. b. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR BARR 10X12 (5/BX) Catalog #68751510105
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1796-2022·2022-10-05
Mckesson DermaCol Collagen Dressings Recalled for Storage Temperature Excursion
Mckesson recalls DermaCol collagen dressings exposed to temperature excursions during storage (June-August 2021). FDA stated adverse health consequences are unlikely.
Product
a. DERMARITE INDUSTRIES DermaCol Collagen Dressing DermaCol Without Border Collagen / Sodium Alginate / Carboxyl Methylcellulose (CMC) / Ethylenediamine-tetraacetic Acid (EDTA) 4 X 4 Inch 10 Count Model Number: 00303E. b. DERMARITE INDUSTRIES DermaCol Ag Silver Collagen…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1743-2022·2022-09-21
BIOPHEN UFH Control Plasma Includes Incorrect Product Labeling in Package
BIOPHEN UFH Control Plasma boxes contain incorrect product labeling. Aniara Diagnostica LLC is recalling 13 units (Lot FA2035) distributed in Illinois and Michigan.
Product
BIOPHEN UFH Control Plasma
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-1740-2022·2022-09-21
Helix Elite SARS-CoV-2 Reference Standard Recalled for Unregistered UK Distribution
Microbiologics Inc. has recalled Helix Elite Inactivated SARS-CoV-2 reference standards distributed to the United Kingdom because the product was not registered for use in that region.
Product
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
Category
Medical Device
Distribution
0 states
LowFDA (Drugs)·D-1304-2022·2022-08-10
Tacrolimus Ointment Recalled for Defective Containers That Split
Glenmark Pharmaceuticals is recalling Tacrolimus Ointment 0.1% because tubes may split at the side seam. The recall affects over 654,000 units distributed nationwide.
Product
TACROLIMUS — TACROLIMUS (TACROLIMUS)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1299-2022·2022-08-03
Juice Beauty lip moisturizer recalled for failed dissolution specifications
Juice Beauty The Organic Solution SPF 8 lip moisturizer is being recalled due to failed dissolution specifications. The recall affects 35,313 tubes distributed in California.
Product
Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566
Category
Drug
Distribution
1 state
LowFDA (Devices)·Z-1465-2022·2022-08-03
ZEISS Axio Observer 5 Microscope Recalled for Incorrect Device Identification Label
Zeiss is recalling ZEISS Axio Observer 5 microscopes due to an incorrect Unique Device Identification (UDI) label installed on some units. The labeling discrepancy affects device tracking and identification.
Product
ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1390-2022·2022-07-27
Erythropoietin Control Product Instructions Contain Incorrect CE Marking
R & D Systems is replacing Instructions for Use (IFU) for Quantikine IVD Erythropoietin Human Serum Controls due to an incorrect CE marking designation that should not appear on the self-certified product.
Product
Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1393-2022·2022-07-27
NeuRx Diaphragm Pacing System Labeling Revised for Storage Clarity
Synapse Biomedical revised labeling for the NeuRx Diaphragm Pacing System to clarify that temperature range symbols indicate storage conditions, not transport or package conditions. The revision affects 71 units distributed in the United States.
Product
NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing…
Category
Medical Device
Distribution
19 states
LowFDA (Drugs)·D-1173-2022·2022-07-13
Mometasone Furoate Topical Solution Recalled Due to Defective Containers
Glenmark Pharmaceuticals is recalling Mometasone Furoate Topical Solution USP 0.1% due to defective containers. Approximately 98,307 packs were distributed nationwide.
Product
MOMETASONE FUROATE — MOMETASONE FUROATE (MOMETASONE FUROATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Food)·F-1344-2022·2022-06-29
Pedialyte Immune Support Raspberry Lemonade recalled for container leakage risk
Abbott Laboratories is recalling approximately 121,918 cases of Pedialyte with Immune Support Raspberry Lemonade due to potential container leakage. The recall affects multiple states.
Product
Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Raspberry Lemonade Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT) 1L*** INGREDIENTS: WATER, DEXTROSE***Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219-3034 USA
Category
Food
Distribution
28 states
LowFDA (Devices)·Z-1125-2022·2022-06-01
Medical device labeling error: KWIK-STIK® plus Clostridium perfringens
Microbiologics Inc recalled 8 units of KWIK-STIK® plus Clostridium perfringens due to a labeling error. The affected lot (801-44-4) was distributed to laboratories in the United States and internationally.
Product
KWIK-STIK" plus: Clostridium perfringens
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0879-2022·2022-05-25
Open Nature Cough Drops recalled due to subpotent menthol content
Bestco LLC is recalling Open Nature Cough Drops (Menthol flavor) due to insufficient menthol content. Products may not be effective as labeled.
Product
Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally Flavored, packaged in Bags of 30 lozenges, Distributed By Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 96566-0009, UPC 0 79893 41266 5
Category
Drug
Distribution
4 states
LowFDA (Devices)·Z-1056-2022·2022-05-18
Bone Graft Syringe Recall: Patient Chart Labels List Incorrect Part Numbers
Cerapedics is recalling putty i-FACTOR Peptide Enhanced Bone Graft syringes because patient chart labels contain incorrect Part Numbers and volume amounts. The company discovered the labeling discrepancy in 572 units distributed nationwide.
Product
putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
Category
Medical Device
Distribution
Distributed nationwide