The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

5451–5475 of 21589

  • ModerateFDA (Drugs)·D-0762-2021·2021-09-01

    PDI Povidone-Iodine Cleansing Scrub Swabstick Recalled for Subpotency

    Professional Disposables International is recalling PDI Povidone-Iodine Cleansing Scrub Swabsticks distributed nationwide because the product is subpotent—meaning it contains less active ingredient than specified.

    Product
    PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2336-2021·2021-09-01

    KeyPrint Soft Dental Resin Recalled for Incorrect European Labeling

    Straumann USA LLC recalled KeyPrint Soft resin bottles (Lot KJ2858) that were distributed with European product labels instead of US-compliant labeling. Dental professionals should verify if they received affected units.

    Product
    KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·21192·2021-09-01

    PetSmart Recalls Top Paw Double Diner Dog Bowls for Laceration Hazard

    PetSmart is recalling about 100,300 Top Paw Double Diner Dog Bowls because the gasket on the bottom can come off, leaving a sharp unfinished edge that poses a risk of laceration. Three reports of cuts and scratches have been received.

    Product
    Top Paw® Double Diner Dog Bowls
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0756-2021·2021-09-01

    Micafungin for Injection Recalled for Incomplete Package Insert

    Xellia Pharmaceuticals USA is recalling Micafungin for Injection 50 mg/vial due to an incomplete package insert that omits required sections on Adverse Reactions, Drug Interactions, and Use in Specific Populations.

    Product
    Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-036-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0760-2021·2021-09-01

    PVP Iodine Prep Pads Recalled for Potency Below Specification

    Professional Disposables International is recalling PVP Iodine Prep Pads distributed nationwide because the product is subpotent—meaning the active ingredient strength falls below FDA specifications. Affected lots were distributed across the United States.

    Product
    PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateCPSC·21777·2021-08-26

    Ryan and Rose Cutie Spoovel Children's Eating Utensils Choking Hazard Recall

    Ryan and Rose is recalling Cutie Spoovel children's eating utensils because the handle can break off when bitten, releasing small parts that pose a choking hazard to young children. No injuries or choking incidents have been reported.

    Product
    Cutie Spoovel children's eating utensils
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·21188·2021-08-25

    Wee Gallery wooden tray puzzles recalled for choking hazard

    Wee Gallery is recalling Ocean and Safari animal wooden tray puzzles because the octopus and elephant puzzle pieces can break, posing a choking hazard to young children.

    Product
    Ocean and Safari animal wooden tray puzzles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0913-2021·2021-08-25

    HiPP HA Infant Formula Recalled for Missing FDA Premarket Notification and Labeling

    Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Milk Formula because required FDA premarket notifications were not submitted and products lack mandatory English labeling as required by federal regulations.

    Product
    HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0728-2021·2021-08-25

    Avicel Microcrystalline Cellulose Recall for Out-of-Specification Conductivity

    DuPont Nutrition USA, Inc. is recalling Avicel microcrystalline cellulose (bulk PH101 NF, PH102 NF, PH200 NF) due to out-of-specification conductivity results. The product was distributed nationwide and internationally.

    Product
    Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0752-2021·2021-08-25

    Triamcinolone Acetonide Ointment Mispack Recall by Teligent Pharma

    Teligent Pharma is recalling Triamcinolone Acetonide Ointment USP 0.1% due to a labeling mispack affecting Lot #16630 with expiration 03/2023. The recall was issued due to incorrect labeling on the product.

    Product
    Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-014-80 ; packaged in tubes.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0751-2021·2021-08-25

    Econazole Nitrate Cream 1% recalled due to labeling mispack

    Teligent Pharma is recalling Econazole Nitrate Cream 1% in 85-gram bulk tubes due to incorrect labeling. The product was distributed nationwide.

    Product
    Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0726-2021·2021-08-25

    Gavilyte-C Oral Solution Recalled for Failed Stability Specification

    Novel Laboratories/Lupin Pharmaceuticals is recalling Gavilyte-C (polyethylene glycol-3350 and electrolytes with flavor pack) due to failed stability testing and out-of-specification osmolarity. The product is distributed nationwide.

    Product
    GAVILYTE - C — GAVILYTE - C (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0912-2021·2021-08-25

    HiPP HA Infant Formula Recalled for Missing Pre-Market Notification

    Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula because required pre-market notifications were not submitted to the FDA and products lack mandatory English labeling.

    Product
    HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk Formula
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0876-2021·2021-08-25

    Chicken of the Sea Genova Meal Kits recalled for quality standards

    Chicken of the Sea is recalling promotional Genova Meal Kits because products included in the kits were prepared in a home kitchen that did not meet quality standards.

    Product
    Chicken of the Sea Genova Meal Kit; Kits include dry whole wheat pasta, dried basil and parsley, 2 cans of Genova Tuna, pesto, Kalamata olives, sundried tomatoes, dates.
    Category
    Food
    Distribution
    12 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
  • ModerateFDA (Drugs)·D-0729-2021·2021-08-25

    Acetaminophen 325 mg tablets recalled for discoloration and cGMP deviations

    Spirit Pharmaceuticals is recalling Acetaminophen 325 mg Regular Strength Pain Reliever tablets due to discoloration and current good manufacturing practice (cGMP) deviations. The recall affects one lot distributed nationwide.

    Product
    Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0727-2021·2021-08-25

    Cholestene Capsules Recalled for Marketing Without Approved Application

    High Performance Formulas is recalling Cholestene capsules (red yeast rice supplement, 1200 mg per 2 capsules, 120-count bottles) because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formulas, L.L.C. (HPF, L.L.C.) P.O. Box 1311, Morrisville, PA 19067, UPC 640485-10093-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0724-2021·2021-08-25

    Combipatch Transdermal System Recalled for Failed Stability Specifications

    Noven Pharmaceuticals is recalling Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day because certain lots failed stability specifications and tested out of specification for shear.

    Product
    COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) — COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0725-2021·2021-08-25

    Combipatch Transdermal Patch Recall Due to Stability Failure

    Noven Pharmaceuticals is recalling certain lots of Combipatch (estradiol/norethindrone acetate transdermal system) distributed nationwide because the patches failed stability testing and fell out of specification for shear properties.

    Product
    COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) — COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0860-2021·2021-08-18

    Monfefo Turmeric Shot Recalled Due to Manufacturing Non-Compliance

    Monfefo LLC is recalling Monfefo brand Turmeric Shot in 2oz glass bottles because the product was not manufactured according to specifications. Affected lots were distributed across multiple states.

    Product
    Monfefo brand Turmeric Shot; 2oz; Cold Pressed Juice Blend; packaged in glass bottle
    Category
    Food
    Distribution
    19 states
  • ModerateNHTSA·21V646000·2021-08-18

    2022 BMW X4 Tire Information Label May Contain Incorrect Size and Pressure

    BMW is recalling certain 2022 X4 vehicles because the tire information label may contain incorrect tire size and pressure information. Installing wrong-sized or improperly inflated tires increases the risk of a crash.

    Product
    BMW — BMW X4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2210-2021·2021-08-18

    InTouch 2131 Medical Device Recalled for Distribution to Residential Users

    Stryker's InTouch 2131 medical device, intended for healthcare facilities, was distributed to residential customers. Home users may not understand healthcare-specific instructions, creating a risk of improper use.

    Product
    InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0703-2021·2021-08-18

    Venlafaxine 50 mg Tablets Recalled for Wrong Strength

    SUN PHARMACEUTICAL INDUSTRIES INC is recalling Venlafaxine Tablets labeled as 50 mg because bottles contain Venlafaxine 37.5 mg tablets, creating a dosing error risk.

    Product
    Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvari, Kabay Janos u.29.Hungary. Product of India NDC 16714-657-01
    Category
    Drug
    Distribution
    1 state
  • ModerateCPSC·21185·2021-08-18

    Primark Recalls 8-Pack Scent Stamper Pens for Elevated Benzyl Alcohol

    Primark is recalling about 9,500 8-pack Scent Stamper Pens due to elevated levels of benzyl alcohol in the purple pen, which poses a risk of skin irritation. No injuries have been reported.

    Product
    8-Pack Scent Stamper Pens
    Category
    Consumer Product
    Distribution
    Distributed nationwide