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.

5526–5550 of 21589

  • ModerateFDA (Drugs)·D-0660-2021·2021-07-21

    Cipla Solifenacin Succinate Tablets Recalled for CGMP Deviations

    Cipla USA is recalling 7,228 bottles of Solifenacin Succinate Tablets, 10 mg (Lot #GG90819, expiring 06/2021) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufactured for Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL, 33323, NDC 69097-261-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateCPSC·21763·2021-07-15

    Real Flame Arroyo and Hideaway Wood Burning Fire Pits Recalled for Fire Hazard

    Real Flame is recalling approximately 700 Arroyo and Hideaway wood burning fire pits sold at Crate and Barrel because wood stored under the units can ignite, posing a fire hazard. One incident with minor property damage has been reported.

    Product
    Arroyo and Hideaway Wood Burning Fire Pits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0651-2021·2021-07-14

    Xylocaine Lidocaine Injection Recalled for Low Epinephrine Assay Results

    Fresenius Kabi USA LLC is recalling Xylocaine-MPF with Epinephrine 1:200,000 injection vials nationwide due to low out-of-specification results for epinephrine assay.

    Product
    XYLOCAINE — XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2022-2021·2021-07-14

    GE Healthcare Revolution CT user interface fails to confirm scan group addition

    The GE Healthcare Revolution CT system's user interface fails to update and confirm when scan group names are added using certain characters. This configuration defect requires a software fix to ensure proper scan group setup.

    Product
    The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs includ
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2012-2021·2021-07-14

    ACE Control Set stability claim failure requires updated handling instructions

    Sentinel CH SpA is recalling ACE Control Set diagnostic control kits due to stability claims after reconstitution that do not meet specified requirements. Updated handling instructions have been provided to affected users.

    Product
    ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·21164·2021-07-14

    Walgreens Recalls Disney Baby Winnie the Pooh Rattle Sets for Choking Hazard

    Walgreens is recalling about 54,000 Disney Baby Winnie the Pooh Rattle Sets because the feet can detach and pose a choking hazard to young children. Consumers should immediately remove the rattle from children and contact Walgreens for a refund.

    Product
    Disney Baby Winnie the Pooh Rattle Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·21163·2021-07-14

    Academy Sports Ozone 500 24-Inch Bicycles Recalled for Fall Hazard

    Academy Sports + Outdoors is recalling about 3,860 Ozone 500 Girls' and Boys' Elevate 24-Inch Bicycles because the rear shock spring can become stuck, creating a pinch point and posing a fall hazard to riders.

    Product
    Ozone 500® Girls' and Boys' Elevate 24-Inch Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0786-2021·2021-07-14

    Hatch Verde Salsa Recalled for Potential Foreign Material

    Heritage Family Specialty Foods, Inc. is recalling Hatch Verde Salsa Medium (12 oz jars) due to potential foreign material contamination. The recall affects 646 cases distributed nationwide.

    Product
    Hatch Verde Salsa Medium Net Wt. 12 oz (340g) 6 jars per case packaged in clamshell container UPC Code: 810041591999
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2023-2021·2021-07-14

    GE Revolution CT scanner user interface fails to confirm scan group names

    The GE Revolution CT imaging system's user interface fails to update and confirm when scan group names contain characters other than letters, numbers, or spaces, potentially causing user uncertainty during scan setup.

    Product
    The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either witho
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0771-2021·2021-07-14

    Yakult Nonfat Probiotic Drink recalled for Candida pelliculosa

    Yakult U.S.A. Inc. is recalling Yakult Nonfat Probiotic Drink (2.7 FL. OZ. bottles) because testing found trace levels of yeast and the presence of Candida pelliculosa in the product.

    Product
    Yakult Nonfat Probiotic Drink; Live and active Lactobacillus casei Shitota; 2.7 FL. OZ. (80 mL), 5 individual bottles per pack, 10 packs per case. Bottle UPC: 4520 8812 5 pack UPC: 6 99235 00100 7 Ingredients: Water, Sugar, Nonfat Milk, Glucose, Natural Flavors, Lactobacillus
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-0787-2021·2021-07-14

    Taco Casa Green Salsa Recalled for Potential Foreign Material

    Heritage Family Specialty Foods is recalling Taco Casa Green Salsa due to potential foreign material contamination. The affected product was distributed nationwide.

    Product
    E6164J2 Taco Casa Green Salsa 8 x 4 lb (1.8 kg) pouches
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2021-2021·2021-07-14

    GE Revolution CT User Interface Issue with Scan Groups

    The GE Revolution CT user interface may fail to confirm when scan group names are added if they contain characters other than letters, numbers, or spaces.

    Product
    The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs inclu
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2031-2021·2021-07-14

    Sterile Femoral Angiography Drape Sticks; Cannot Unfold Properly

    Cardinal Health is recalling 574 units of Sterile Femoral Angiography Drapes because the plastic film causes the drapes to stick, preventing proper unfolding and application during surgery.

    Product
    Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0650-2021·2021-07-14

    Genentech Xolair Injection Recalled for Failed Stability Specifications

    Genentech is recalling two lots of Xolair (omalizumab) injection nationwide due to out-of-specification Polysorbate 20 content detected at the 12-month stability testing timepoint. The affected lots are 3352758 and 3352759, both with August 2021 expiration dates.

    Product
    XOLAIR — XOLAIR (OMALIZUMAB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateCPSC·21760·2021-07-08

    ECHO EGi-2300 Watt Generators Recalled for Fire and Burn Hazard

    ECHO EGi-2300 Watt Generators can overheat and catch fire, posing a fire and burn hazard. The manufacturer has received four reports of overheating or fire, though no injuries have been reported.

    Product
    ECHO EGi-2300 Watt Generators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1967-2021·2021-07-07

    Dragonfly Laryngeal Surface Electrode recalled for sterilization process deviation

    Spes Medica is recalling Dragonfly Laryngeal Surface Electrodes due to possible deviations in ethylene oxide sterilization process. Affected lot LS20G3274I was distributed in California, Massachusetts, and South Carolina.

    Product
    Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous EMG monitoring of the larynx during surgical procedures.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1960-2021·2021-07-07

    Edwards TruWave Pressure Monitoring Set Tubing Detachment Recall

    Edwards Lifesciences is recalling Edwards TruWave pressure monitoring sets due to potential tubing detachment from the blood sampling system. No illnesses or injuries have been reported.

    Product
    Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Food)·F-0755-2021·2021-07-07

    Just Nuts Japanese Style Peanuts recalled for unapproved food dye

    El Presidente Foods is recalling Just Nuts Japanese Style Peanuts (6.17 oz bags, Lot 317-20, expiring July 19, 2021) distributed in California because FDA inspection found the peanuts contained non-approved Red #6 dye.

    Product
    Just Nuts Japanese Style Peanuts, Crunchy coated peanuts. 6.17 oz. polyethene bags. UPC : 1 90236 0000 1 Distributed by El Presidente, Foods Co., Yorba Linda, CA Made in Mexico.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0643-2021·2021-07-07

    QiYu Hand Sanitizer Recalled for Subpotent Ethyl Alcohol Content

    HoYu (US) Logistics Inc is recalling QiYu Hand Sanitizer (75% ethyl alcohol) because the product is subpotent. The recall affects 30,880 bottles distributed nationwide.

    Product
    QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun District, Guanzhou, China Distributed by HoYu (US) Logistics Inc UPC 6 926645 716288
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateCPSC·21758·2021-07-01

    Rejuvenation Deep Frame Mirrors Recalled for Laceration Hazard

    Rejuvenation is recalling about 3,325 Deep Frame Mirrors because the adhesive securing the mirror glass can fail, causing the glass to detach and fall out of the frame. Rejuvenation has received 18 reports of glass detaching, though no injuries have been reported.

    Product
    Deep Frame Mirrors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1907-2021·2021-06-30

    Ultrasonic Probe Covers Recalled for Missing FDA Clearance

    Exact Medical Manufacturing is recalling ultrasonic probe covers due to missing FDA 510(k) clearance for use in natural or surgical body openings. The recall affects 8,800 units distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.

    Product
    Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1913-2021·2021-06-30

    Ultrasonic Transducer Probe Cover Recalled for Lacking FDA Clearance

    Exact Medical Manufacturing recalled 5,621 ultrasonic transducer probe covers (Item A-AU-1002N) lacking FDA 510(k) clearance for use in natural or surgical body openings, distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.

    Product
    Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1943-2021·2021-06-30

    LED therapy device pads recalled for improper cord assembly and power failure risk

    Inlightened Partners LLC is recalling 926 inLight Medical LED Pads due to improper assembly of cord connectors, which may cause power interruptions and controller shutdown.

    Product
    inLight Medical LED Pads used with Polychromatic light technology system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0636-2021·2021-06-30

    Diflorasone Diacetate Ointment recalled for foreign particles

    Teligent Pharma is recalling Diflorasone Diacetate Ointment USP 0.05% due to the presence of foreign particles found during routine stability testing. The recall affects 6,240 tubes distributed nationwide.

    Product
    Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0638-2021·2021-06-30

    Mephyton Phytonadione 5 mg Tablets Recall for Failed Impurity Specifications

    Bausch Health Companies is recalling Mephyton (Phytonadione) 5 mg tablets nationwide because certain lots failed impurities and degradation specifications. Affected consumers should contact their healthcare provider.

    Product
    Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, 08807, USA, NDC 0187-1704-05.
    Category
    Drug
    Distribution
    Distributed nationwide