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.

7126–7150 of 21595

  • ModerateFDA (Drugs)·D-1114-2020·2020-04-15

    Herbal Doctor Remedies Recalls Cellulite Off for CGMP Deviations

    Herbal Doctor Remedies is recalling Cellulite Off because the product was found to be misbranded as an unapproved new drug.

    Product
    Cellulite Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1659-2020·2020-04-15

    Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1646-2020·2020-04-15

    Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

    Biomet, Inc. is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Drugs)·D-1123-2020·2020-04-15

    Herbal Doctor Remedies Recalls Fire Off Capsules Due to Misbranding

    Herbal Doctor Remedies is recalling Fire Off 500mg capsules because the products are misbranded as unapproved new drugs.

    Product
    Fire Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1152-2020·2020-04-15

    FDA Recalls Purple Gold Balm for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Purple Gold Balm because the product is misbranded as an unapproved new drug. The balm was sold online in the U.S. and internationally.

    Product
    Purple Gold Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1145-2020·2020-04-15

    Herbal Doctor Remedies Recalls Nasal Ez Capsules Due to Misbranding

    Herbal Doctor Remedies is recalling Nasal Ez capsules because they were found to be misbranded as unapproved new drugs.

    Product
    Nasal Ez, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1172-2020·2020-04-15

    Herbal Doctor Remedies Recalls Worm Off Capsules Due to Misbranding

    Herbal Doctor Remedies is recalling Worm Off capsules because they are misbranded as unapproved new drugs. The products were sold online in the US and internationally.

    Product
    Worm Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1126-2020·2020-04-15

    Herbal Doctor Remedies Recalls Fungo Balm for Unapproved New Drug Status

    Herbal Doctor Remedies is recalling Fungo Balm because the product is misbranded as an unapproved new drug. The balm was sold online in the U.S. and internationally.

    Product
    Fungo Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600- 0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1141-2020·2020-04-15

    Herbal Doctor Remedies Recalls Lump Shrinker Capsules for Misbranding

    Herbal Doctor Remedies is recalling Lump Shrinker capsules because the products are misbranded as unapproved new drugs.

    Product
    Lump Shrinker, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1154-2020·2020-04-15

    Herbal Doctor Remedies Recalls Reman-6 Capsules Due to CGMP Deviations

    Herbal Doctor Remedies is recalling Reman-6 500mg capsules because the products were found to be misbranded as unapproved new drugs.

    Product
    Reman-6, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1170-2020·2020-04-15

    Vitiligo Off Ointment Recalled for Being an Unapproved New Drug

    Herbal Doctor Remedies is recalling Vitiligo Off Ointment because it is misbranded as an unapproved new drug.

    Product
    Vitiligo Off Ointment, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1144-2020·2020-04-15

    Herbal Doctor Remedies Recalls Metabolic Booster Capsules for Misbranding

    Herbal Doctor Remedies is recalling Metabolic Booster 500mg capsules because they are misbranded as unapproved new drugs.

    Product
    Metabolic Booster. 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1153-2020·2020-04-15

    Purple Gold Balm Recalled for Misbranding as Unapproved New Drug

    Herbal Doctor Remedies is recalling Purple Gold Balm because it is misbranded as an unapproved new drug. The product was sold online in the US and internationally.

    Product
    Purple Gold Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1666-2020·2020-04-15

    Biomet Recalls Knee Tibial Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 units of StageOne Knee Tibial Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1645-2020·2020-04-15

    Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 hip stem cement spacer molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1665-2020·2020-04-15

    Biomet Knee Spacer Mold Recalled for Potential Cleaning Deficiencies

    Biomet is recalling StageOne Knee Femoral Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1653-2020·2020-04-15

    Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns

    Biomet, Inc. is recalling 230,001 units of BIOMET StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1670-2020·2020-04-15

    Biomet Recalls Custom StageOne Hip Femoral Reinforcement Due to Cleaning Concerns

    Biomet, Inc. is recalling specific lots of Custom StageOne Hip Femoral Reinforcement due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Drugs)·D-1115-2020·2020-04-15

    Herbal Doctor Remedies Recalls De-Fibroidin Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling De-Fibroidin 500mg capsules because the products were found to be misbranded as unapproved new drugs due to CGMP deviations.

    Product
    De-Fibroidin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1650-2020·2020-04-15

    Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1655-2020·2020-04-15

    Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns

    Biomet, Inc. is recalling StageOne Hip Cement Spacer Molds because of a potentially insufficient cleaning process or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Drugs)·D-1161-2020·2020-04-15

    Herbal Doctor Remedies Recalls Skin Moist Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling Skin Moist 500mg capsules because they were found to be misbranded as unapproved new drugs.

    Product
    Skin Moist, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1667-2020·2020-04-15

    Biomet Recalls Knee Tibial Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 units of StageOne Knee Tibial Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring.

    Product
    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1687-2020·2020-04-15

    Baxter Recalls GEM Microvascular Couplers Due to Labeling Mismatch

    Baxter Healthcare is recalling GEM Microvascular Anastomotic Coupler Devices because the size labeling on the outer tray may not match the inner tray.

    Product
    GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1163-2020·2020-04-15

    Herbal Doctor Remedies Recalls Stomach Cleanser Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling Stomach Cleanser capsules because the products were found to be misbranded as unapproved new drugs.

    Product
    Stomach Cleanser, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states