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.

1426–1450 of 2769

  • LowFDA (Drugs)·D-0241-2017·2017-01-04

    VirtPrex Prenatal Tablets Recalled Due to API Manufacturer Import Alert

    Virtus Pharmaceuticals is recalling VirtPrex Prenatal/Postnatal Tablets because the active ingredient manufacturer is on an FDA Import Alert.

    Product
    VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic Acid and DHA, packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-348-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0237-2017·2017-01-04

    Cipher Pharmaceuticals Recalls Subpotent Inova Benzoyl Peroxide Pads

    Cipher Pharmaceuticals is recalling 216 boxes of Inova benzoyl peroxide pads due to subpotent drug levels. The product was distributed in Arizona, Colorado, and Ohio.

    Product
    INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of benzolyl peroxide 3g, 28 capsules of topical tocopherol 5%, OTC, Manufactured for: Innocutis Holdings, LLC, Charleston, SC 29401, NDC 68712-013-01
    Category
    Drug
    Distribution
    3 states
  • LowFDA (Devices)·Z-0936-2017·2017-01-04

    Sterling Diagnostics Recalls Urea Nitrogen Diagnostic Kits Due to Expiration Date Error

    Sterling Diagnostics is recalling 131 Urea Nitrogen diagnostic kits because previously extended expiration dates were rescinded. The kits were distributed in Michigan and the Philippines.

    Product
    Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0932-2017·2017-01-04

    Sterling Diagnostics Recalls Enzymatic Glucose Diagnostic Kits

    Sterling Diagnostics is recalling 40 units of Enzymatic Glucose diagnostic kits due to a revision of previously extended expiration dates.

    Product
    Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0931-2017·2017-01-04

    Sterling Diagnostics Recalls Creatinine Diagnostic Kits Due to Expiration Date Error

    Sterling Diagnostics is recalling 182 units of Creatinine/Endpoint diagnostic kits because previously extended expiration dates were rescinded.

    Product
    Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0935-2017·2017-01-04

    Sterling Diagnostics Recalls SGPT Colorimetric Kits Due to Expiration Date Error

    Sterling Diagnostics is recalling SGPT Colorimetric kits because previously extended expiration dates were rescinded.

    Product
    Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0937-2017·2017-01-04

    Sterling Diagnostics Recalls Enzymatic Uric Acid Diagnostic Kits

    Sterling Diagnostics is recalling 173 Enzymatic Uric Acid diagnostic kits because previously extended expiration dates were rescinded.

    Product
    Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0847-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 175 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Food)·F-0820-2017·2016-12-28

    Hi-Tech Pharmacal Recalls Liquid Vitamin C Due to Low Active Ingredient

    Hi-Tech Pharmacal is recalling Rx CHOICE brand Liquid Vitamin C because the active ingredient is at a lower level than stated on the label.

    Product
    Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
    Category
    Drug
    Distribution
    13 states
  • LowFDA (Devices)·Z-0834-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 228 dental implant abutments because a limited number of product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0225-2017·2016-12-28

    Tom's of Maine Antiperspirant Recalled for Incorrect Back Label

    Les Emballages Knowlton Inc. is recalling Tom's of Maine Naturally Dry Natural Powder Antiperspirant Stick because an incorrect back label was applied to the product.

    Product
    Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed by: Tom's of Maine, Kennebunk, ME 04043, Made in Canada, Unit UPC: 077326831953 Case UPC: 10077326831950
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0837-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 64 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Food)·F-0817-2017·2016-12-28

    Hi-Tech Pharmacal Recalls Liquid Vitamin C Due to pH Issues

    Hi-Tech Pharmacal is recalling Rx CHOICE brand Liquid Vitamin C because the product failed to meet pH specifications.

    Product
    Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
    Category
    Drug
    Distribution
    16 states
  • LowFDA (Devices)·Z-0779-2017·2016-12-28

    PerkinElmer Recalls DELFIA hFSH Kits Due to Stability Testing Failures

    PerkinElmer Health Sciences is recalling 79 DELFIA hFSH kits because real-time stability testing showed decreased hFSH concentrations in control sera.

    Product
    DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-0897-2017·2016-12-28

    PerkinElmer Recalls EnLite Neonatal TREC Kits for Missing UDI Labels

    PerkinElmer is recalling 73 EnLite Neonatal TREC Kits because the Unique Device Identifier (UDI) is missing from the outer box labels.

    Product
    EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR" EnLite instrument. The test is indicated for use as
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0848-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 216 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0854-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 124 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0861-2017·2016-12-28

    Biomet 3i Low Profile Abutment Recall for Unsealed Packaging

    Biomet 3i is recalling 1,371 low profile abutments because a limited number of product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0851-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 137 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0840-2017·2016-12-28

    Biomet 3i Low Profile Dental Abutment Recall for Packaging Seal Defects

    Biomet 3i is recalling 108 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0835-2017·2016-12-28

    Biomet 3i Low Profile Dental Implant Abutments Recalled for Packaging Defect

    Biomet 3i is recalling 50 units of Low Profile Dental Implant Abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0842-2017·2016-12-28

    Biomet 3i Dental Abutments Recalled for Potential Packaging Seal Defects

    Biomet 3i is recalling 46 units of a specific dental implant abutment because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0856-2017·2016-12-28

    Biomet 3i Dental Implant Abutment Recall for Packaging Seal Defects

    Biomet 3i is recalling 28 dental implant abutments because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0862-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 191 Low Profile Abutment units because some pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0857-2017·2016-12-28

    Biomet 3i Low Profile Abutment Recall for Unsealed Packaging

    Biomet 3i is recalling 458 low profile abutment impression copings because a limited number of product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states