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.

15226–15250 of 21645

  • ModerateFDA (Food)·F-0601-2016·2016-02-24

    Umpqua Dairy Cultured Sour Cream Recalled for Potential Antibiotic Residue

    Umpqua Dairy Products Co is recalling cultured sour cream because the milk used was presumptive positive for beta lactam antibiotics.

    Product
    Pint Umpqua Dairy Cultured Sour Cream, Item no. 03654, net w. 16 oz.; UPC 0 71203 00403 4. Half Pint Umpqua Dairy Cultured Sour Cream, Item no. 03751, net w. 18 oz.; UPC 0 71203 00401 0.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0581-2016·2016-02-24

    B&D Seafoods Recalls Frozen Swai Fillets Due to Nitrofurans

    B&D Seafoods is recalling frozen swai fillets because they contain nitrofurans, a prohibited veterinary drug.

    Product
    Pacific Surf Swai Fillets IQF 2 lbs x 5/ctn, 5 lbs x 6/ctn (size 7-9) Farm Raised Product of Vietnam Packed for: PAFCO Global Seafood Services IQF well trimmed, boneless, skinless, belly off, fat off, red meat off Products are packaged in cardboard boxes.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0536-2016·2016-02-24

    Sunset Natural Products Recalls Abee Med Dietary Supplement

    Sunset Natural Products is recalling Abee Med dietary supplements under a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Abee Med, 60 capsules per bottle. Manufactured by Sunset Natural Products
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0617-2016·2016-02-24

    Sunset Natural Products Recalls Hepasil Dietary Supplement Capsules

    Sunset Natural Products Inc. is recalling Hepasil dietary supplements under a consent decree requiring the destruction of products distributed since April 2, 2014.

    Product
    Hepasil, sold in bulk of 500,000 capsules.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0540-2016·2016-02-24

    Sunset Natural Products Recalls Neuro-Cetin Dietary Supplement Capsules

    Sunset Natural Products Inc. is recalling Neuro-Cetin dietary supplements under a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Neuro-Cetin, sold in bulk 50,000 capsules.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0604-2016·2016-02-24

    Umpqua Mountain Blackberry Revel Ice Cream Recalled for Antibiotic Residue

    Umpqua Dairy Products Co is recalling Umpqua Mountain Blackberry Revel Ice Cream because the milk used was presumptive positive for beta lactam antibiotics.

    Product
    Umpqua Mountain Blackberry Revel Ice Cream, Item no. 12823, 1.75 quart container, UPC 0 71203 08758 7
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0537-2016·2016-02-24

    Sunset Natural Products Recalls Argindione Dietary Supplement Capsules

    Sunset Natural Products Inc. is recalling Argindione capsules pursuant to a consent decree requiring the destruction of supplements manufactured or distributed since April 2, 2014.

    Product
    Argindione, sold as bulk of 50,000 capsules.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0816-2016·2016-02-24

    Smith & Nephew Recalls Legion Hemi Stepped Tibial Wedges Due to Incorrect Screws

    Smith & Nephew is recalling 8 units of Legion Hemi Stepped Tibial Wedges because the included screws were too long to properly affix the device.

    Product
    LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Food)·F-0607-2016·2016-02-24

    Umpqua Vanilla Ice Cream Mix Recalled for Potential Antibiotic Residue

    Umpqua Dairy Products Co is recalling Lowfat Vanilla Soft Serve Ice Cream Mix because the milk used was presumptively positive for beta-lactam antibiotics.

    Product
    Umpqua Lowfat Vanilla Soft Serve Ice Cream Mix 4% (Red), item no. 04952, Half gallon container. UPC 0 71203 00494 2.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0583-2016·2016-02-24

    Little Temptations Sour Strawberries Recalled for Undeclared Dyes

    JNC International Inc. is recalling Little Temptations Sour Strawberries because they contain undeclared FD&C Blue #1 and Yellow #5.

    Product
    Little Temptations Sour Strawberries Net Wt. 7.5 oz (213g) Packed by: Crystal Temptations, North Arlington, NJ 07031 UPC 611190469401
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0809-2016·2016-02-24

    Exactech Acapella One Interbody Fusion Device Packaging Labeling Recall

    Exactech is recalling 19 Acapella One Interbody Fusion Devices due to incorrect external and internal packaging labels.

    Product
    Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-0543-2016·2016-02-24

    Sunset Natural Products Recalls Prostax Forte Dietary Supplement

    Sunset Natural Products Inc. is recalling Prostax Forte dietary supplements pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2, 2014.

    Product
    Prostax Forte, sold in bulk of 50,000 capsules.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0606-2016·2016-02-24

    Umpqua Peppermint Candy Ice Cream Recalled for Potential Antibiotic Residue

    Umpqua Dairy Products Co is recalling Peppermint Candy Ice Cream because the milk used was presumptive positive for beta lactam antibiotics.

    Product
    Umpqua Peppermint Candy Ice Cream, Item no. 11150, 3 Gallon container, UPC 0 71203 08645 0
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0665-2016·2016-02-24

    Bonita Pharmaceuticals Recalls Menthocin Patch with Lidocaine-Strong

    Bonita Pharmaceuticals is recalling Menthocin Patch with Lidocaine-Strong because it was marketed without an approved NDA or ANDA.

    Product
    Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches, RX Only, Manufactured for Bonita Pharmaceuticals LLC 6380 Commerce Drive Westland, MI 48185-9120, USA NDC 53598-0012-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0813-2016·2016-02-24

    Sorin Dual Stage Venous Return Catheter Recalled for Incorrect Instructions

    Sorin Group USA is recalling 60 units of Dual Stage Venous Return Catheters because the cases contained incorrect Instructions For Use (IFU).

    Product
    Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Cardiopulmonary bypass catheter.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0619-2016·2016-02-24

    Red Diamond Coffee Concentrate Recalled for Elevated pH Levels

    Red Diamond, Inc. is recalling 22 units of European Roast Coffee Concentrate due to elevated pH levels in an acidified product.

    Product
    RED DIAMOND, European Roast, COFFEE CONCENTRATE, Mix Ratio 69 + 1, Net contents 1/2 Gallon, Manufactured for RED DIAMOND, Birmingham, AL; Item # 111590
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0582-2016·2016-02-24

    B&D Seafoods Recalls Frozen Swai Fillets Due to Nitrofurans

    B&D Seafoods Inc. is recalling frozen swai fillets because they contain nitrofurans. The product was distributed in California and Florida.

    Product
    Happy Fish Swai Fillet Farm Raised Product of Vietnam Net Weight: 22 lbs IQF well trimmed, boneless, skinless, belly off, fat off, red meat off Products are packaged in cardboard boxes.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0811-2016·2016-02-24

    Verathon Recalls GlideScope Video Laryngoscope Blades for Manual Revision

    Verathon is recalling GlideScope and AVL video laryngoscope reusable blades to update the Operations and Maintenance Manual regarding chemical cleaning cycle limits.

    Product
    GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScope Video Laryngoscope is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0610-2016·2016-02-24

    Umpqua Vanilla Ice Cream Recalled Due to Presumptive Antibiotic Presence

    Umpqua Dairy Products Co is recalling 400 three-gallon containers of Umpqua Vanilla Ice Cream because the milk used was presumptive positive for beta-lactam antibiotics.

    Product
    Umpqua Vanilla Ice Cream, item no. 09997, 3 gallon container. UPC 0 71203 08620 7
    Category
    Food
    Distribution
    6 states