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.

14626–14650 of 21645

  • ModerateFDA (Food)·F-1340-2016·2016-05-25

    Bunge Harvest Value Canola Salad Oil Recalled for Foreign Material

    Bunge Oil North America Inc. is recalling Harvest Value Canola Salad Oil due to the presence of a foreign material inside the jugs.

    Product
    Harvest Value Canola Salad Oil, 35 lb., (15.88 kg), Distributed By: U.S. Foodservice, Inc,, Rosemont, IL 60018, UPC 5 07 58108 02454 5
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-1360-2016·2016-05-25

    Bunge Smart Source Canola Salad Oil Recalled for Foreign Material

    Bunge Oil North America Inc. is recalling 60 cases of Smart Source Canola Salad Oil due to the presence of a foreign material inside the jugs.

    Product
    Smart Source Canola Salad Oil (Aceite de Canola Para Ensalada), Net Wt./Peso Neto 35 lbs. (15.88 kg), Marketed by/Comercializado por Independent Marketing Alliance, Houston, TX 77079, UPC 0 08 22486 17655 6
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-1361-2016·2016-05-25

    Royal Snacks Jalapeno Pistachio Recalled for Undeclared Dyes

    Royal Snacks Inc is recalling Jalapeno Pistachio Royal Size products because they contain undeclared Yellow #5 and Blue #1 dyes.

    Product
    Royal Snacks Jalapeno Pistachio Royal Size
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-1343-2016·2016-05-25

    Bunge Smart Source Soybean Oil Recalled for Foreign Material

    Bunge Oil North America Inc. is recalling 1,080 cases of Smart Source Clear Soybean Frying Oil due to the presence of a foreign material inside the jugs.

    Product
    Smart Source Clear Soybean Frying Oil (Aceite de Soya Transparente Para Freir), Net Wt./Peso Neto 35 lbs. (15.88 kg), Marketed by/Comercializado por Independent Marketing Alliance, Houston, TX 77079, UPC 0 08 22486 13046 6
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-1362-2016·2016-05-25

    MegaFood Multi for Women 40+ Recalled for Missing Iron Warning

    FoodState, Inc. is recalling MegaFood Multi for Women 40+ multivitamin bottles because the labels lack the required iron warning statement and child-resistant cap.

    Product
    MegaFood Multi for Women 40+, Multivitamin & Mineral Dietary Supplement packaged in glass bottles UPC:5149410321 -Packaged 60 tablets; UPC:5149410322 -Packaged 120 tablets
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1342-2016·2016-05-25

    Bunge Vegetable Oil Recalled for Foreign Material Presence

    Bunge Oil North America Inc. is recalling Katy's Kitchen Soybean Salad Oil due to the presence of foreign material inside the jugs.

    Product
    Katy's Kitchen Soybean Salad Oil (Soya Aceite Para Ensalada), Marketed by/Comercializado por Independent Marketing Alliance, Houston, TX 77079, Product of USA/Producto de EE.UU., UPC 0 08 22486 13034 3
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-1352-2016·2016-05-25

    Bunge Daily Chef Frying Oil Recalled for Foreign Material

    Bunge Oil North America Inc. is recalling specific lots of Daily Chef Food Service Pure Clear Frying Oil due to the presence of foreign material inside the jugs.

    Product
    Daily Chef Food Service Pure Clear Frying Oil (Aceite Transparente Para Freir), Net/Neto 4.5 Gal (17L) and Net Wt/Peso Neto, 35 lbs. (15.8 kg), Distributed By: Sam's West Inc., Bentonville, AR 72716, UPC 0 78742 06148 1
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-1338-2016·2016-05-25

    Bunge Canola Oil Recalled for Foreign Material Presence

    Bunge Oil North America Inc. is recalling Harvest Value Canola Liquid Frying Oil due to the presence of a foreign material inside the jugs.

    Product
    Harvest Value Canola Liquid Frying Oil, 35 lb., (15.88 kg), Distributed By: U.S. Foodservice, Inc,, Rosemont, IL 60018, UPC 5 07 58108 01988 6
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1646-2016·2016-05-18

    Biomerieux Vitek 2 Gram Positive Susceptibility Test Cards Recalled for Labeling Error

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0843-2016·2016-05-18

    Sesderma Salises Acne Gel Recalled for cGMP Deviations

    Sesderma is recalling Salises Facial Moisturizing Acne Treatment Gel due to cGMP deviations. The product does not comply with current Good Manufacturing Practice requirements.

    Product
    Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain --- NDC 63181-0016
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0849-2016·2016-05-18

    Sesderma Recalls Repaskin 30 Sunscreen for cGMP Deviations

    Sesderma is recalling 27 bottles of Repaskin 30 Facial Sunscreen gel cream because the product does not comply with cGMP requirements.

    Product
    Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0010-1
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0840-2016·2016-05-18

    Mylan Recalls Paliperidone Extended-Release Tablets Due to Dissolution Failures

    Mylan Pharmaceuticals is recalling 2,928 bottles of Paliperidone Extended-Release Tablets, 1.5 mg, because they failed dissolution specifications at a three-month stability time point.

    Product
    Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1657-2016·2016-05-18

    Siemens ADVIA Chemistry Triglycerides Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Triglycerides reagents because N-Acetylcysteine and Metamizole can cause falsely depressed test results.

    Product
    ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1622-2016·2016-05-18

    Siemens Recalls Dimension Vista BUN Reagent Cartridges for Inaccurate Results

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista BUN Flex reagent cartridges because they may produce inaccurate patient or quality control results.

    Product
    Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1650-2016·2016-05-18

    Neusoft NeuViz 64 CT Scanner Software Icon Mismatch Recall

    Neusoft Medical Systems is recalling seven NeuViz 64 CT scanners due to a software defect where side decubitus icons did not match the patient position description.

    Product
    NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1633-2016·2016-05-18

    Siemens Dimension Sirolimus Reagent Cartridge Recalled for Stability Failure

    Siemens Healthcare Diagnostics is recalling Dimension Sirolimus reagent cartridges due to open well instability that may cause inaccurate test results.

    Product
    Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry…
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Drugs)·D-0847-2016·2016-05-18

    Sesderma Dryses Deodorant Recalled for cGMP Deviations

    Sesderma is recalling 195 bottles of Dryses Aluminum Chlorohydrate Deodorant for Women due to cGMP deviations.

    Product
    Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 16047-0029-1
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1628-2016·2016-05-18

    Baxter Recalls GEM FlowCoupler Devices Due to Packaging Defect

    Baxter Healthcare is recalling 630 units of GEM FlowCoupler devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0844-2016·2016-05-18

    Sesderma Recalls Repaskin 50 Sunscreen Due to cGMP Deviations

    Sesderma is recalling 15 tubes of Repaskin 50 sunscreen because the product does not comply with current Good Manufacturing Practice (cGMP) requirements.

    Product
    Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0846-2016·2016-05-18

    Sesderma Dryses Deodorant Recalled for cGMP Deviations

    Sesderma is recalling Dryses Aluminum Chlorohydrate Deodorant for Men because the product does not comply with cGMP requirements.

    Product
    Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0019-1 UPC 8 470002 075221
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0842-2016·2016-05-18

    Sesderma Recalls Dryses Antiperspirant Solution for cGMP Deviations

    Sesderma is recalling 542 bottles of Dryses Aluminum Chlorohydrate Antiperspirant Solution because the product does not comply with cGMP requirements.

    Product
    Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0015-1, UPC 8 470003 244268
    Category
    Drug
    Distribution
    4 states
  • ModerateUSDA FSIS·041-2016·2016-05-18

    Aurnish Pork Dumplings Recalled for Undeclared MSG

    Aurnish Enterprises is recalling pork dumplings because they contain monosodium glutamate (MSG) that is not listed on the label.

    Product
    Recall Notification Report 041-2016 (Pork Dumpling Products)
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1627-2016·2016-05-18

    Baxter GEM Flowcoupler Recall Due to Packaging Puncture Risk

    Baxter Healthcare is recalling 315 units of GEM Flowcoupler devices because the instructions for use booklet may puncture the outer Tyvek lid.

    Product
    GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide