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.

6251–6275 of 21595

  • ModerateFDA (Devices)·Z-0450-2021·2020-11-25

    Ortho Recalls VITROS SARS-CoV-2 IgG Calibrators Due to Elevated Signal Values

    Ortho Clinical Diagnostics is recalling specific lots of VITROS SARS-CoV-2 IgG Calibrators because they produced elevated signal values. The recall also includes one lot of IgG Controls with decreased signal.

    Product
    VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized labora
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0122-2021·2020-11-25

    Denali Coffee Cream Stabilizer Recalled for Ingredient Substitution

    Denali Ingredients LLC is recalling 3,050 lbs of Supreme1251 Coffee Cream Stabilizer because it was made with Citric Acid instead of Sodium Citrate.

    Product
    Denali Ingredients Supreme1251Coffee Cream Stabilizer, Item 501251-1014, 50 lb. bag. Storage: For maximum Performance Store at Ambient Temperatures Below 85F. This container is intended for Food Products Only. No other Use Authorized. Dispose of in an Approved Manner.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0088-2021·2020-11-25

    Milbar Recalls Malin + Goetz Dandruff Shampoo Due to GMP Deviations

    Milbar Laboratories is recalling 5,312 bottles of Malin + Goetz dandruff shampoo due to Good Manufacturing Practice deviations.

    Product
    (Malin + Goetz) dandruff Shampoo Psoriasis and Sebborrheic Dermatitis (1.9% Pyrithione Zinc) 8 fl.oz bottle, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0469-2021·2020-11-25

    Siemens Artis X-Ray Systems Recalled for Overvoltage Protection Defect

    Siemens is recalling 26 Artis X-ray systems worldwide because incorrect diodes may fail to protect against overvoltage, potentially causing system malfunction.

    Product
    Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0474-2021·2020-11-25

    Siemens Atellica IM 1600 Analyzer Recalled for Custom Settings Reset

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzers because scanning a new kit lot may reset custom settings to defaults.

    Product
    Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0091-2021·2020-11-25

    Milbar Recalls MD Complete Breakout Treatment Due to GMP Deviations

    Milbar Laboratories is voluntarily recalling 2,655 bottles of MD Complete Breakout Treatment due to Good Manufacturing Practice deviations.

    Product
    MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl. oz. (30mL) bottles, MD Professional LLC, Minneapolis, MN
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0099-2021·2020-11-25

    Grato Holdings Recalls Homeopathic Energy Catalyst for Undeclared API

    Grato Holdings is recalling 399 bottles of Homeopathic Energy Catalyst due to an undeclared active pharmaceutical ingredient and incorrect formulation.

    Product
    Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologicals, Inc. 469 W. Parkland Drive Sandy, UT 84070. NDC 43742-0756-1.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0085-2021·2020-11-25

    Milbar Recalls DCL AHA Lightening Gel Due to GMP Deviations

    Milbar Laboratories is recalling 1,608 bottles of DCL AHA Lightening Gel due to Good Manufacturing Practice deviations. The product was distributed nationwide and internationally.

    Product
    DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486500471
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0106-2021·2020-11-25

    Apotex Recalls Aripiprazole Tablets Due to Dissolution Failures

    Apotex Corp. is recalling Aripiprazole Tablets 15 mg because they failed to meet dissolution specifications. The affected products were distributed nationwide in the USA.

    Product
    Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0459-2021·2020-11-25

    Exactech Equinoxe Cage Glenoid Posterior Augment Recalled for Mislabeling

    Exactech, Inc. is recalling 69 Equinoxe Cage Glenoid, Posterior Augment, Left, Medium devices because they may be mislabeled.

    Product
    Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Drugs)·D-0086-2021·2020-11-25

    Milbar Recalls DCL SA Scalp Therapy Shampoo Due to GMP Deviations

    Milbar Laboratories is recalling 1,815 bottles of DCL SA Scalp Therapy Shampoo due to Good Manufacturing Practice (GMP) deviations.

    Product
    DCL SA Scalp Therapy Shampoo (Salicylic Acid 3%) 300 ml/10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486503120
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0093-2021·2020-11-25

    Milbar Recalls Willa Pore Perfector Pads Due to GMP Deviations

    Milbar Laboratories is recalling 2,638 jars of Willa Pore Perfector pads due to Good Manufacturing Practice deviations. The product was distributed nationwide and internationally.

    Product
    Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0468-2021·2020-11-25

    Strauss 25 Carbide Dental Burs Recalled for Incorrect Packaging

    Coltene Whaledent Inc is recalling Strauss 25 Carbide Dental Burs because they were incorrectly packaged as a different model, posing a risk of excessive material removal.

    Product
    Strauss 25 Carbide Dental Burs (100057XXV)
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0083-2021·2020-11-25

    Milbar Recalls DCL Active Mattifying Cleanser Due to GMP Deviations

    Milbar Laboratories is recalling 4,878 tubes of DCL Active Mattifying Cleanser due to Good Manufacturing Practice (GMP) deviations. The product was distributed nationwide and internationally.

    Product
    DCL Active Mattifying Cleanser (Salicylic Acid 2%), 125mL/4.2 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486509627
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0119-2021·2020-11-25

    FreshPoint Roma Diced Tomatoes Recalled for Potential Foreign Material

    FreshPoint Dallas is recalling specific lots of Roma diced tomatoes due to potential foreign material. The products were distributed in Texas and Kansas.

    Product
    FC TOMATOES ROMA DICED 3/8" 1/5#; FC TOMATOES ROMA DICED 3/8" 4/5#, and FC TOMATOES ROMA DICED 3/8" 2/5# all packaged in white plastic trays with heat seal lid, packed inside a cardboard box
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0089-2021·2020-11-25

    Milbar Recalls Malin + Goetz Salicylic Gel Due to GMP Deviations

    Milbar Laboratories is recalling 2,664 tubes of Malin + Goetz Salicylic Gel due to Good Manufacturing Practice (GMP) deviations.

    Product
    (Malin + Goetz) Salicylic Gel (2% Salicylic Acid) 0.5 fl.oz. 15 mL tube, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0462-2021·2020-11-25

    LivaNova VNS Therapy AspireSR Generator Recall for Serial Number Error

    LivaNova is recalling 134 VNS Therapy AspireSR Generators because an extra digit in the serial number makes them incompatible with specific therapy programmers.

    Product
    VNS Therapy¿ AspireSR¿ Generator
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Drugs)·D-0095-2021·2020-11-25

    Milbar Recalls DCL Clear Skin Anti-Blemish Hydrator Due to GMP Deviations

    Milbar Laboratories is voluntarily recalling 927 tubes of DCL Clear Skin Anti-Blemish Hydrator due to Good Manufacturing Practice (GMP) deviations.

    Product
    DCL Clear Skin Anti-Blemish Hydrator (2% Salicylic Acid), 50ml/1.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0094-2021·2020-11-25

    Milbar Recalls DCL Alpha Beta Gel Toner Due to GMP Deviations

    Milbar Laboratories is voluntarily recalling DCL Alpha Beta Gel Toner due to Good Manufacturing Practice (GMP) deviations. The product was distributed nationwide and internationally.

    Product
    DCL Alpha Beta Gel Toner (1.95% Salicylic Acid) 200 mL/6.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0440-2021·2020-11-25

    Inova Lasers Recalls Class IV New Era Medical Laser Devices

    Inova Lasers LLC is recalling eight Class IV New Era medical laser devices because they failed to comply with Electronic Product Radiation Control regulations.

    Product
    Class IV New Era medical laser device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0460-2021·2020-11-25

    Exactech Equinoxe Cage Glenoid Posterior Augment Recalled for Mislabeling

    Exactech is recalling 40 Equinoxe Cage Glenoid, Posterior Augment, Right, Medium devices due to potential mislabeling. The devices were distributed to US and international consignees.

    Product
    Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Drugs)·D-0090-2021·2020-11-25

    Milbar Recalls Malin+Goetz SPF 30 Face Moisturizer Due to GMP Deviations

    Milbar Laboratories is recalling 3,692 tubes of Malin+Goetz SPF 30 Face Moisturizer due to Good Manufacturing Practice (GMP) deviations.

    Product
    (Malin+Goetz) spf 30 face moisturizer (Avobenzone 3%, Homosalate 10 %, Octinoxate 7.5%, Octisalate 2.75%, Oxybenzone 5%) 1.7 fl. oz. 50 ml tubes, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001
    Category
    Drug
    Distribution
    1 state