Hazard

Missing Labeling recalls

27 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 27
Critical: 0
Severe: 5
Most recent: 2025-02-05

Of the 27 missing labeling recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (19%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all missing labeling recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 27

ModerateFDA (Drugs)·D-0209-2025·2025-02-05
Badger 50 Mineral Sunscreen Recalled for Missing Drug Facts Labeling
The W.S. Badger Company is recalling Badger 50 mineral sunscreen tins lacking the complete drug facts label, barcode, and directions for use. The recall affects 4,834 tins distributed nationwide.
Product
BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0057-2025·2024-10-30
Sour Charlie bread recalled for undeclared wheat allergen
Salt City Baking Company recalls Sour Charlie bread due to missing ingredient labeling. Product contains wheat flour but was distributed without an Ingredients Statement, posing a risk to wheat-allergic consumers.
Product
Sour Charlie bread, #2092, bag of 6 rolls (net wt. 7oz), 48 mini loaves per case. UPC code 0076011611894. Product was packaged bulk in a clear plastic bag inside a cardboard box and was not sold to consumers. Product was not labeled with a best by/exp date but recalling firm s
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2966-2024·2024-09-11
Impella 5.5 Pump Labeling Updated Due to Device Interaction
Abiomed updated Impella 5.5 cardiac pump labeling to document a potential interaction with Shockwave Coronary IVL Catheter during coronary procedures. No injuries have been reported.
Product
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2955-2024·2024-09-11
Impella CP Smart Assist Set Lacks Labeling for Potential Device Interaction
Abiomed is updating labeling for the Impella CP Smart Assist Set to warn about a potential interaction with the Shockwave Coronary IVL Catheter when used during coronary interventions. The interaction was previously undocumented in the device instructions.
Product
Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2965-2024·2024-09-11
Impella 5.5 Device Recalled for Missing Labeling on Catheter Interaction
Abiomed is updating labeling for Impella 5.5 cardiac support pumps to include information about a potential device interaction with Shockwave Coronary IVL Catheters during coronary interventions.
Product
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2954-2024·2024-09-11
Impella CP Smart Assist Set: Device interaction safety labeling update
Abiomed is updating labeling for the Impella CP Smart Assist Set to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures. No illnesses or injuries have been reported.
Product
Impella CP Smart Assist Set, EU; Product Code: 0048-0014;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2129-2024·2024-06-19
OMTech Desktop Laser Engraver recalled for missing safety interlocks
Rygel Advanced Machines recalls OMTech Desktop Laser Engravers due to missing safety interlocks and labeling. The devices lack required redundant interlocks and certification labels that prevent accidental laser exposure.
Product
OMTech Desktop Laser Engraver
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1294-2024·2024-03-20
BVI Visitec Irrigation Handle lacks manufacturing and expiration dates
Beaver Visitec International is recalling 3,000 BVI Visitec Irrigation Handles because the pack and pouch labels are missing manufacturing and expiration date information.
Product
BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0095-2024·2023-10-18
FDA Recalls Zemits NDPrime Yag Laser for Missing Safety Interlocks
Advance-Esthetic LLC is recalling the MED-810A Zemits NDPrime Yag Tattoo Removal Laser nationwide due to failure to comply with radiation safety regulations. The device is missing critical safety interlocks and warning labels.
Product
MED-810A Zemits NDPrime Laser products
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0356-2022·2021-12-15
Philips BV Pulsera X-ray Systems Missing Required Temperature Documentation
Philips has recalled BV Pulsera mobile X-ray systems due to missing temperature specifications in the instructions for use. The X-ray tank and image intensifier lack maximum surface temperature documentation, creating a burn hazard.
Product
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0240-2022·2021-12-01
Medical X-Ray Systems Missing Required Radiation Warning Labels
Philips Healthcare is recalling ProxiDiagnost N90 diagnostic X-ray systems that lack required FDA radiation warning labels. Some units nationwide were found missing the mandatory radiation safety labels and certification statements required by federal standards.
Product
ProxiDiagnost N90 is multi-functional general R/F systems.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2339-2021·2021-09-01
OASIS MRI table pads recalled for missing latex allergen labeling
Hitachi Healthcare Americas has recalled OASIS MRI System table pads due to missing labels and user manual notification about dry natural rubber content. The missing notification violates federal labeling requirements for this latex allergen.
Product
OASIS MRI System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0757-2021·2021-09-01
Micafungin for Injection recalled for incomplete package insert
Xellia Pharmaceuticals is recalling Micafungin for Injection due to an incomplete package insert that omits required sections on adverse reactions, drug interactions, and use in specific populations.
Product
Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0910-2021·2021-08-25
HiPP HA Infant Formula Recalled for Inadequate Iron and Missing Labeling
Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula (76,000 units) because some products contain less than the required iron per serving and lack mandatory FDA-compliant English labeling.
Product
HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0925-2021·2021-08-25
HiPP UK Stage 2 Infant Formula Recalled for Missing FDA Notifications and Improper Labeling
Able Groupe Inc is recalling HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula because required pre-market FDA notifications were not submitted and products lack mandatory English-language labeling as required by federal regulations.
Product
HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0922-2021·2021-08-25
Lebenswert Stage 2 Infant Formula Recalled for Missing Labeling
Able Groupe Inc is recalling Lebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk Formula (76,000 units) sold directly through littlebundle.com. The formula was not submitted for required FDA pre-market notification and lacks mandatory English-language labeling.
Product
Lebenswert Folgemilch Stage 2 Organic Follow-On Infant Milk Formula
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0916-2021·2021-08-25
Holle Bio Stage 1 Organic Infant Formula Recall for Inadequate Iron Content and Labeling
Able Groupe Inc is recalling Holle Bio Stage 1 Organic Infant Milk Formula because the product may contain insufficient iron for some infants and lacks required FDA labeling statements. The recall affects approximately 76,000 units sold directly through littlebundle.com.
Product
Holle Bio Stage 1 Organic Infant Milk Formula
Category
Food
Distribution
0 states
HighFDA (Food)·F-0908-2021·2021-08-25
HiPP AR Germany Anti-Reflux Infant Formula Lacks Required FDA Approval and Labeling
Able Groupe Inc is recalling HiPP AR Germany Anti-Reflux Milk Formula because required pre-market FDA notifications were not submitted and products lack mandatory English labeling required by federal regulations.
Product
HiPP AR Germany Anti-Reflux Milk Formula
Category
Food
Distribution
0 states
HighFDA (Food)·F-0927-2021·2021-08-25
Kendamil Organic Stage 2 Infant Formula Recalled for Missing Labeling
Able Groupe Inc is recalling Kendamil Organic Stage 2 Follow on Milk Formula because required pre-market FDA notifications were not submitted and labeling does not comply with federal requirements.
Product
Kendamil Organic Stage 2 Follow on Milk Formula
Category
Food
Distribution
0 states
HighFDA (Food)·F-0915-2021·2021-08-25
HiPP German Stage 2 Infant Formula Lacks Required FDA Pre-Market Approval and Labeling
Able Groupe Inc is recalling HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula because it was not submitted for required FDA pre-market notification and lacks mandatory English labeling statements.
Product
HiPP German Stage 2 Combiotic Follow-on Infant Milk Formula
Category
Food
Distribution
0 states
ModerateFDA (Food)·F-0920-2021·2021-08-25
Holle Goat Stage 2 Infant Formula Recalled for Missing FDA Pre-Market Notification
Able Groupe Inc is recalling Holle Goat Stage 2 Organic Follow-On Infant Milk Formula (76,000 units) because required pre-market notifications were not submitted to the FDA and products lack mandatory labeling in English.
Product
Holle Goat Stage 2 Organic Follow-On Infant Milk Formula
Category
Food
Distribution
0 states
SevereUSDA FSIS·049-2018·2018-06-13
HF Food Distributors Recalls Uninspected Sliced Cooked Ham Products
HF Food Distributors is recalling approximately 142 pounds of sliced cooked ham produced without federal inspection. The products were shipped to Head Start centers in Puerto Rico.
Product
HF Food Distributors Recalls Pork Products Produced without Benefit of Inspection
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-1152-2018·2018-03-28
Arrow International Recalls ARROWg+ard Blue PLUS Catheters Due to Missing Lid Information
Arrow International Inc is recalling 420 ARROWg+ard Blue PLUS catheters because certain lots may be missing lot numbers, expiration dates, and UDI information on the lid.
Product
ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against cat
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-0998-2018·2018-03-21
Arrow International Recalls CVC Kits Missing Lot Number Stickers
Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot number, expiration date, and UDI information.
Product
AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of flui
Category
Medical Device
Distribution
7 states
LowFDA (Devices)·Z-0999-2018·2018-03-21
Arrow International Recalls CVC Kits Missing Lot and UDI Information
Arrow International Inc is recalling 23,904 AGB+ Pressure Injectable Quad-Lumen CVC Kits because some units are missing stickers containing lot number, expiration date, and UDI information.
Product
AGB+ Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluid
Category
Medical Device
Distribution
7 states