The Recall Desk

Hazard

Mis Labeling recalls

9,607 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
9,607
Critical
160
Severe
588
Most recent
2026-09-10

Of the 9,607 mis labeling recalls we have scored against our rubric, 160 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 588 (6%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all mis 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.

3576–3600 of 9607

  • ModerateFDA (Drugs)·D-0808-2018·2018-05-23

    Prescript Pharmaceuticals Recalls Clindamycin Capsules Due to Labeling Error

    Prescript Pharmaceuticals is recalling Clindamycin 300 mg capsules because the storage temperature label differs from the manufacturer's original declaration.

    Product
    Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct for: Lannett Co. Inc., Philadelphia, PA 19136. Mnfct. by: Lannett Co. Inc., Philadelphia, PA 19136. Pckgd by PreScript Pharm. Inc., Pleasanton, CA 94566. NDC: 00527-1383-01, Bar Code 0784-28-11
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0807-2018·2018-05-23

    Prescript Pharmaceuticals Recalls Chlorhexidine Liquid Due to Labeling Error

    Prescript Pharmaceuticals is recalling Chlorhexidine 0.12% liquid due to a storage temperature labeling discrepancy. The product was distributed in California.

    Product
    Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laboratories, Chicago, IL 60609. Mnfct by: pharmaceutical Assoiates, Inc., Greenville, SC 29605. Distrib by: PreScript Pharm. INC., Pleasanton, CA 94588. NDC: 00116-2001-16, Bar Code 1385-38-482
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0805-2018·2018-05-23

    Prescript Pharmaceuticals Recalls Clindamycin Capsules Due to Labeling Error

    Prescript Pharmaceuticals is recalling 50 containers of Clindamycin 150 mg capsules in California due to a storage temperature labeling discrepancy.

    Product
    Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannett Co. Inc., Philadelphia, PA. Mnfct for: Lannett Co. Inc., Philadelphia, PA. Pckgd by PreScript Pharm. Inc. Pleasanton, CA 94566. NC 00527-1382-01, Bar Code 0639-30-176
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0809-2018·2018-05-23

    Prescript Pharmaceuticals Recalls Acetaminophen with Codeine Tablets for Labeling Error

    Prescript Pharmaceuticals is recalling Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets due to a storage temperature labeling discrepancy.

    Product
    Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Mallinckrodt Inc. Hazelwood, MO 63042. Mnfct by:Mallinckrodt Inc. Hazelwood, MO 63042. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566 NDC: 00406-0484-10 Bar Code 007
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0803-2018·2018-05-23

    Boiron Recalls Calendula Cream Due to Outer Carton Labeling Error

    Boiron Inc. is recalling 52,810 tubes of Calendula Cream because the outer carton incorrectly lists the active ingredient concentration as 7% instead of 10%.

    Product
    Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0818-2018·2018-05-23

    Sun Pharma Recalls Riomet Metformin Solution Due to Labeling Errors

    Sun Pharmaceutical Industries is recalling Riomet (metformin hydrochloride) oral solution due to identified labeling discrepancies in the patient literature.

    Product
    RIOMET — RIOMET (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1875-2018·2018-05-23

    Epic Extremity Plate System Caddy Recalled for Artwork Error

    Epic Extremity, LLC is recalling 9 units of the 10x10 Plate Caddy due to an artwork error that misidentifies a specific plate and screw.

    Product
    Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-35XX-N)
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-1883-2018·2018-05-23

    Coltene Whaledent Recalls Carbide Burs Due to Incorrect Product Number Labeling

    Coltene Whaledent Inc is recalling 11 packs of Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack carbide burs because they are labeled with an incorrect product number.

    Product
    Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1874-2018·2018-05-23

    Epic Extremity Plate System Recalled for Packaging Labeling Error

    Epic Extremity, LLC is recalling 6 units of the Epic Extremity Plate System due to a packaging error that misidentifies a specific plate and screw.

    Product
    Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Food)·F-1400-2018·2018-05-16

    Peaceful Mountain Stomach Rescue Recalled as Unapproved New Drug

    Grato Holdings is recalling Peaceful Mountain Stomach Rescue dietary supplements because they are unapproved new drugs based on disease claims.

    Product
    Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1762-2018·2018-05-16

    Bard Peripheral Vascular Recalls POWERPORT ClearVUE Catheters Due to Incorrect Instructions

    Bard Peripheral Vascular Inc is recalling 1551 units of the POWERPORT ClearVUE Slim catheter because the included Patient ID Card has incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1679-2018·2018-05-16

    Siemens Recalls IMMULITE Assays Due to Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling specific IMMULITE assay lots because the instructions for use do not list the biotin concentration that causes interference, posing a risk of inaccurate test results.

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1687-2018·2018-05-16

    Siemens Recalls ADVIA Centaur Cyclosporine Due to Labeling Error

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Cyclosporine because the instructions for use incorrectly state the biotin non-interference level.

    Product
    ADVIA Centaur¿ Cyclosporine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1684-2018·2018-05-16

    Siemens Recalls Immulite Assays Due to Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling certain IMMULITE assays because the instructions for use do not list the biotin concentration that causes interference, posing a risk of inaccurate test results.

    Product
    IMMULITE ¿ /IMMULITE ¿ 1000 TG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1397-2018·2018-05-16

    Sugarfina Platinum Bling Ring Recalled for Undeclared Fish Allergen

    Sugarfina LLC is recalling Platinum Bling Rings because an internal audit found undeclared fish gelatin. The product was distributed in 16 states.

    Product
    Sugarfina Platinum Bling Ring; Product SKU No. R-1790 UPC: 840278116139 Net W. 21g ().7 oz.) Sculpted from dark chocolate, these interlocking rings have a thin sugar shell brushed with edible silver: Ingredients: Dark Chocolate (cocoa, sugar, cocoa butter, soy lecithin (
    Category
    Food
    Distribution
    16 states
  • HighUSDA FSIS·037-2018·2018-05-16

    Blount Fine Foods Recalls Chicken Tortilla Soup Due To Undeclared Wheat

    Blount Fine Foods is recalling approximately 720 pounds of Chicken Tortilla Soup because the product contains undeclared wheat and may be mislabeled.

    Product
    Blount Fine Foods — Blount Fine Foods Recalls Chicken Tortilla Soup Products Due To Misbranding And An Undeclared Allergen
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1394-2018·2018-05-16

    NatureBox Recalls Whole Wheat Chocolate Animal Cookies Due to Undeclared Soy

    NatureBox is recalling specific lots of Whole Wheat Chocolate Animal Cookies because they may contain undeclared soy lecithin.

    Product
    Whole Wheat Chocolate Animal Cookies; 5 oz. pouch, 5 lb. Corporate bags UPC: 8 58950 00508 6 Ingredients: Whole Wheat Flour, Unbleached Enriched Wheat Flour (niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid). soluble Corn Prebiotic Fiber, Granulated sugar,
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1685-2018·2018-05-16

    Siemens Recalls IMMULITE Assays Due to Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling specific IMMULITE assay kits because the user instructions fail to list the biotin concentration levels that cause test interference. This omission may lead to inaccurate diagnostic results for patients taking biotin supplements.

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi TG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1683-2018·2018-05-16

    Siemens Recalls IMMULITE Assays Due to Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling specific IMMULITE assay lots because the instructions fail to list biotin interference concentrations, potentially causing inaccurate test results.

    Product
    IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1389-2018·2018-05-16

    Bob's Red Mill Whole Wheat Bread Mix Recalled for Undeclared Wheat

    Bob's Red Mill is recalling 100% Whole Wheat Bread Mix because the label fails to declare wheat, a major allergen.

    Product
    Bob's Red Mill 100% Whole Wheat Bread Mix, Item 1674C194, packaged in flexible packaging bag, 4 bags to a cardboard case, each bag weighs 19 oz. The UPC is 0 39978 00667 7. The label on the FRONT side of a package is read in parts: "***Bob's Red Mill ***100% WHOLE WHEAT BREAD
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1678-2018·2018-05-16

    Siemens IMMULITE CEA Assay Recalled for Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling IMMULITE CEA assays because biotin interference thresholds are not listed in the instructions, potentially affecting test accuracy.

    Product
    IMMULITE ¿ /IMMULITE ¿ 1000 CEA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1674-2018·2018-05-16

    Siemens IMMULITE 2000 Allergy IgE Kit Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Allergy specific IgE Universal Kits because biotin interference is not documented in the instructions for use.

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 3g Allergy specific IgE Universal Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1691-2018·2018-05-16

    Siemens IMMULITE 2000 BR-MA (CA15-3) Assay Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 BR-MA (CA15-3) assays because biotin interference is not listed in the instructions for use.

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1767-2018·2018-05-16

    Bard Peripheral Vascular Recalls POWERPORT ClearVUE Catheters

    Bard Peripheral Vascular Inc is recalling 4,044 POWERPORT ClearVUE catheters because the Patient ID Card contains incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1676-2018·2018-05-16

    Siemens IMMULITE 2000 Folic Acid Assay Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Folic Acid assays because biotin interference is not listed in the instructions for use.

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid
    Category
    Medical Device
    Distribution
    Distributed nationwide