The Recall Desk

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.

726–750 of 2738

  • LowFDA (Drugs)·D-1546-2019·2019-08-07

    NingBo Huize Recalls Dubble Bubble Scented Antibacterial Hand Gel

    NingBo Huize Commodity Co., Ltd. is recalling Dubble Bubble Scented Antibacterial Hand Gel because stability testing was not conducted on the product.

    Product
    AMERICA'S ORIGINAL DUBBLE BUBBLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1532-2019·2019-08-07

    NingBo Huize Recalls SPF 30 Sunscreen Lotion Due to Missing Stability Testing

    NingBo Huize Commodity Co., Ltd. is recalling SPF 30 Sunscreen Lotion because stability testing was not conducted on the manufactured product.

    Product
    SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen, 53mL/1.8fl.oz., OTC, Distributed by: EVANS, Made in China
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1540-2019·2019-08-07

    NingBo Huize Recalls Dots Scented Antibacterial Hand Gel for CGMP Deviations

    NingBo Huize Commodity Co., Ltd. is recalling Dots Scented Antibacterial Hand Gel because stability testing was not conducted on the product.

    Product
    DOTS SCENTED ANTIBACTERIAL HAND GEL STRAWBRRY (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1551-2019·2019-08-07

    Tootsie Roll Hand Gel Recalled for Missing Stability Testing

    NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll Scented Antibacterial Hand Gel because stability testing was not conducted on the product.

    Product
    TOOTSIE ROLL SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1563-2019·2019-08-07

    NingBo Huize Recalls Dippin' Dots Hand Gel Due to Missing Stability Testing

    NingBo Huize is recalling Dippin' Dots Scented Cotton Candy Antibacterial Hand Gel because stability testing was not conducted on the product.

    Product
    DIPPIN' DOTS SCENTED COTTON CANDY ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1544-2019·2019-08-07

    NingBo Huize Recalls CHARMS Antibacterial Hand Gel for Missing Stability Testing

    NingBo Huize Commodity Co., Ltd. is recalling CHARMS Blow Pop Blue Razz Berry Scented Antibacterial Hand Gel because stability testing was not conducted.

    Product
    CHARMS BLOW POP BLUE RAZZ BERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1549-2019·2019-08-07

    Tootsie Roll Hand Gel Recalled for Missing Stability Testing

    NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll Fruit Chews Vanilla Scented Antibacterial Hand Gel because stability testing was not conducted.

    Product
    TOOTSIE ROLL FRUIT CHEWS VANILLA SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1538-2019·2019-08-07

    DOTS Scented Antibacterial Hand Gel Recalled for Stability Testing Deviations

    NingBo Huize Commodity Co., Ltd. is recalling DOTS Scented Antibacterial Hand Gel Orange because stability testing was not conducted on the product.

    Product
    DOTS SCENTED ANTIBACTERIAL HAND GEL ORANGE (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1543-2019·2019-08-07

    NingBo Huize Recalls Watermelon Scented Antibacterial Hand Gel for CGMP Deviations

    NingBo Huize Commodity Co., Ltd. is recalling CHARMS Blow Pop Watermelon Scented Antibacterial Hand Gel because stability testing was not conducted on the product.

    Product
    CHARMS BLOW POP WATERMELON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1531-2019·2019-08-07

    Tootsie Roll Grape Hand Gel Recalled for Missing Stability Testing

    NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll POP Grape Scented Antibacterial Hand Gel because stability testing was not conducted.

    Product
    Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed By: JFL Enterprises, Inc. Cleveland, Ohio 44102, Made in China
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1564-2019·2019-08-07

    Lemon Hand Sanitizer Recalled for Missing Stability Testing

    NingBo Huize Commodity Co., Ltd. is recalling Lemon Hand Sanitizer because stability testing was not conducted on the product.

    Product
    Lemon Hand Sanitizer (Alcohol 62%), 30 mL / 1.0 fl.oz, OTC, Made in China.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-2079-2019·2019-07-31

    Abbott Recalls ARCHITECT BNP Controls Due to Stability Drift

    Abbott Laboratories is recalling ARCHITECT BNP Controls because of a time-dependent stability drift that affects test results.

    Product
    ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1518-2019·2019-07-31

    Lupin Recalls Nystatin and Triamcinolone Acetonide Cream for Stability Failure

    Lupin Pharmaceuticals is recalling Nystatin and Triamcinolone Acetonide Cream due to a failed uniformity of containers test. The recall covers 33,939 tubes distributed nationwide.

    Product
    NYSTATIN AND TRIAMCINOLONE ACETONIDE — NYSTATIN AND TRIAMCINOLONE ACETONIDE (NYSTATIN AND TRIAMCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1490-2019·2019-07-24

    Lupin Recalls Gatifloxacin Ophthalmic Solution Due to Missing Labels

    Lupin Pharmaceuticals is recalling 17,238 bottles of Gatifloxacin Ophthalmic Solution 0.5% because some bottles were found missing their labels.

    Product
    Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1551-2019·2019-07-24

    Wilton Chocolate Decorator Icing Recalled for Mold

    Wilton Brands is voluntarily recalling 15,032 units of Chocolate Decorator Icing due to mold. The product was distributed in 35 states.

    Product
    Wilton Chocolate decorator icing stiff consistency 16 oz plastic tub retail unit 6 or 12 retail units per wholesale unit
    Category
    Food
    Distribution
    37 states
  • LowFDA (Devices)·Z-1974-2019·2019-07-24

    Teleflex Medical Recalls RUSCH CARE Premium Drain Bags for Labeling Issues

    Teleflex Medical is recalling RUSCH CARE Premium Drain bags because the labels are not UDI compliant. The agency states this labeling issue is not likely to affect the device's function or performance.

    Product
    RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1975-2019·2019-07-24

    Teleflex Medical Recalls RUSCH Urinary Drainage Bags for Labeling Issues

    Teleflex Medical is recalling RUSCH Urinary Drainage bags because the labels are not UDI compliant. The missing information does not affect the device's function or performance.

    Product
    RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1438-2019·2019-07-10

    Amneal Recalls Subpotent Esterified Estrogens and Methyltestosterone Tablets

    Amneal Pharmaceuticals is recalling specific lots of Esterified Estrogens & Methyltestosterone tablets due to out-of-specification assay results.

    Product
    Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-171-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1927-2019·2019-07-10

    Roche cobas p 501 Post-Analytical Units Recalled for Loose Flap

    Roche Diagnostics is recalling four cobas p 501 post-analytical units because the tray input flap may become loose and detach from the instrument.

    Product
    cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1439-2019·2019-07-10

    Amneal Recalls Subpotent Esterified Estrogens and Methyltestosterone Tablets

    Amneal Pharmaceuticals is recalling specific lots of Esterified Estrogens & Methyltestosterone Tablets because they failed potency testing.

    Product
    Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-172-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1526-2019·2019-07-10

    Tate & Lyle Recalls Food Starch Due to Potential Wire Contamination

    Tate & Lyle is recalling specific lots of Miraqk Mgl and Nustar food starch because a screen failure may have allowed small pieces of wire to enter the product.

    Product
    Food starch, brand names Miraqk Mgl and Nustar 120 and Nustar 140
    Category
    Food
    Distribution
    0 states
  • LowFDA (Devices)·Z-1928-2019·2019-07-10

    Roche cobas p 701 Post-Analytical Units Recalled for Loose Flap

    Roche Diagnostics is recalling nine cobas p 701 post-analytical units because the tray input flap may become loose and detach.

    Product
    cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
    Category
    Medical Device
    Distribution
    Distributed nationwide