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.

12751–12775 of 21617

  • ModerateFDA (Food)·F-2208-2017·2017-05-17

    Vertical Pharmaceuticals Recalls OB Complete Prenatal Multivitamin Due to Labeling Error

    Vertical Pharmaceuticals is recalling one lot of OB Complete with DHA Prenatal Multivitamin because the label claim for Omega-3 Fatty Acids does not match the actual formulation.

    Product
    Vertical Pharmaceuticals OB Complete with DHA Prenatal Multivitamin, 60 softgels Rx Only, Manufactured for: Vertical Pharmaceuticals, LLC Sayreville, NJ 08872 UPC 368025049603
    Category
    Food
    Distribution
    21 states
  • ModerateFDA (Drugs)·D-0700-2017·2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 7.5 mg, because they failed impurity specifications. The recall covers 6,138 bottles distributed nationwide and in Puerto Rico.

    Product
    Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0699-2017·2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling specific lots of Olanzapine Tablets, 2.5 mg, because they failed impurity specifications.

    Product
    Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2069-2017·2017-05-17

    Almore Microfil Composite Instruments Recalled for Incorrect Sterile Labeling

    Almore International Inc. is recalling Microfil Composite Instruments because packaging labels incorrectly display a sterile symbol, although the devices are not sterile.

    Product
    Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box. Microfil Composite Instruments are intended to be sterilized by the dentist prior to each use. It is used for composite restoration development. The thin…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0702-2017·2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 20 mg, because they failed impurity specifications. The recall covers 14,784 bottles distributed nationwide and in Puerto Rico.

    Product
    Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·048-2017·2017-05-11

    NY Livestock Market Recalls Poultry for Nitrofurazone Residue

    NY Livestock Market, Inc. is recalling approximately 1,495 pounds of whole young chickens due to possible nitrofurazone contamination.

    Product
    NY Livestock Market Inc. — NY Livestock Market, Inc. Recalls Poultry Products Due to Possible Residue Contamination
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2003-2017·2017-05-10

    Anspach Effort Recalls Bearing Sleeves Due to Missing Service Interval

    The Anspach Effort, Inc. is recalling 182 Bearing Sleeve, 10CM Curved units because the supplied directions for use did not contain a recommended service interval.

    Product
    Bearing Sleeve, 10CM Curved Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1953-2017·2017-05-10

    Anspach Effort SC2100 Foot Control Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 320 SC2100 Foot Controls because the supplied directions for use did not contain a recommended service interval.

    Product
    Foot Control, SC2100 Product Usage: Electric system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1980-2017·2017-05-10

    Anspach Effort Pneumatic System Attachment Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 297 pneumatic system attachments because the supplied directions for use did not include a recommended service interval.

    Product
    6.1CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2022-2017·2017-05-10

    Anspach Effort Recalls 14cm QD Angle Attachment for Pneumatic Systems

    The Anspach Effort, Inc. is recalling 238 units of the 14cm QD Angle Attachment because the supplied directions for use did not contain a recommended service interval.

    Product
    14cm QD Angle Attachment Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1917-2017·2017-05-10

    Smith & Nephew Recalls Renovation Thin Osteotome Blades Due to Shelf Life

    Smith & Nephew is recalling Renovation Thin Osteotome Blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY: (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1947-2017·2017-05-10

    Anspach Effort Recalls Electric Handpiece Controls for Missing Service Interval

    The Anspach Effort, Inc. is recalling 32 electric handpiece controls because the supplied directions for use did not contain a recommended service interval.

    Product
    Electric Handpiece EM Hand Control Product Usage: Electric system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1904-2017·2017-05-10

    Breg Inc Recalls Knee Dressings Due to Unsealed Pouches

    Breg Inc is recalling 2,609 units of Knee L/XL Dressings because some may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1909-2017·2017-05-10

    Smith & Nephew Recalls Radial Osteotome Blades Due to Shelf Life Data

    Smith & Nephew is recalling Radial Osteotome Blades because stability data does not support the labeled 10-year shelf life.

    Product
    RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1978-2017·2017-05-10

    Anspach Effort Recalls 26.65cm Attachment for Missing Service Interval

    The Anspach Effort, Inc. is recalling 16 units of the 26.65cm Attachment, Black Max because the supplied directions for use did not contain a recommended service interval.

    Product
    26.65CM ATTACHMENT, BLACK MAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1955-2017·2017-05-10

    Anspach Effort eMax2 Plus Console Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 439 eMax2 Plus consoles because the supplied directions for use did not contain a recommended service interval.

    Product
    Console, eMax2 Plus Product Usage: Electric system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2181-2017·2017-05-10

    Tropicana Orange Juice Recalled for Potential Plastic Fragments

    Quaker Oats Co is recalling one lot of Tropicana orange juice because it may contain small plastic fragments.

    Product
    Tropicana 100% JUICE, orange juice From Concentrate with Other Natural Flavors, 24-10 FL OZ (296 mL) BOTTLES, (TOTAL 240 FL OZ (1.8 GAL) 7L), UPC 48500 75823, Tropicana Manufacturing Company, Inc., Bradenton, Florida 34206 USA
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1982-2017·2017-05-10

    Anspach Effort 5.9CM Pneumatic Attachment Recalled for Missing Service Interval

    The Anspach Effort, Inc. is recalling 49 units of the 5.9CM Attachment, Black Max, because the supplied directions for use did not include a recommended service interval.

    Product
    5.9CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system
    Category
    Medical Device
    Distribution
    Distributed nationwide