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.

18001–18025 of 21645

  • ModerateFDA (Drugs)·D-1490-2014·2014-08-06

    FDA Recalls Unapproved Dermamedics and Therametics Topical Emulsions

    Dermamedics, L.L.C. is recalling Dermamedics and Therametics Complexion Repair Topical Rehydrating Emulsions because the FDA determined they are unapproved new drugs and misbranded.

    Product
    Dermamedics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of DM 1011 and Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2117-2014·2014-08-06

    Dynarex CPR Shield Recalled for Incorrect Orientation Labeling

    Dynarex Corporation is recalling CPR Shields with One Way Valves because the 'THIS SIDE UP' label is on the wrong side, posing a potential health hazard if misused.

    Product
    CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2231-2014·2014-08-06

    Purefruit Chile Recalls Pouched Applesauce Due to Mold Possibility

    Purefruit Chile S.A. is recalling fruty U applesauce, apple cinnamon, due to the possibility of mold. The product was distributed to retail stores nationwide.

    Product
    fruty U applesauce, apple cinnamon; 3.5 oz/20 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box; product is labeled in part, "***fruty U APPLE CINNAMON applesauce***NET WEIGHT 3.53 OZ***FRUTY U…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2274-2014·2014-08-06

    GM Manufacturing Recalls Chitosan Blister Packs for cGMP Violations

    GM Manufacturing is recalling 2,010 units of Chitosan, Blister Pack distributed in California due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    Chitosan, Blister Pack
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1502-2014·2014-08-06

    Daiichi Sankyo Recalls Benicar Tablets Due to Temperature Abuse During Shipping

    Daiichi Sankyo is recalling 262 bottles of Benicar Tablets because they were not stored at controlled room temperature during shipping.

    Product
    Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-103-30 and NDC 65597-103-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1503-2014·2014-08-06

    Benicar HCT Tablets Recalled for Temperature Abuse During Shipping

    Daiichi Sankyo is recalling 108 bottles of Benicar HCT 20 mg/12.5 mg tablets because they were not stored at controlled room temperature during shipping.

    Product
    Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-105-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1492-2014·2014-08-06

    Dermamedics Post Procedure Cream Recalled for Lack of FDA Approval

    Dermamedics, L.L.C. is recalling Post Procedure Cream because the FDA determined the product is an unapproved new drug and misbranded.

    Product
    Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Laser Treatment System with a SKU number of DM 1019
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2121-2014·2014-08-06

    McKesson Horizon Medical Imaging Software Recalled for Image Index Discrepancy

    McKesson Medical Imaging is recalling Horizon Medical Imaging software due to a defect that may cause a mismatch between the expected image index and the actual folder content.

    Product
    Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical…
    Category
    Medical Device
    Distribution
    48 states
  • ModerateFDA (Food)·F-2229-2014·2014-08-06

    Purefruit Chile Recalls Market Pantry Applesauce Due to Mold Risk

    Purefruit Chile S.A. is recalling Market Pantry Apple Cinnamon applesauce pouches due to the possibility of mold. The product was distributed nationwide.

    Product
    Market Pantry Apple Cinnamon; 3.5 oz/12 pk applesauce is packed into a labeled aluminum pouch with plastic screw-on lid and then placed into a labeled cardboard box; product is labeled in part, "***market pantry Apple Cinnamon Fruit Pouch***NET WT 3.5 OZ (100g)***DISTRIBUTED BY…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1506-2014·2014-08-06

    Daiichi Sankyo Recalls Benicar Tablets Due to Temperature Abuse During Shipping

    Daiichi Sankyo is recalling Benicar Tablets (olmesartan medoxomil) 40 mg because some products were not stored at controlled room temperature during shipping.

    Product
    Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-104-30 and 65597-104-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1491-2014·2014-08-06

    Dermamedics Serum Recalled for Lacking FDA Approval

    Dermamedics, L.L.C. is recalling Calm and Correct Serum because the product is an unapproved new drug and misbranded.

    Product
    Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB10062 and 4 oz. containers with a SKU number of BB10068.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1499-2014·2014-08-06

    Teva Recalls Lansoprazole Triple Therapy Blister Packs Due to Impurities

    Teva Pharmaceuticals is recalling 89,215 blister packs of triple therapy containing lansoprazole, clarithromycin, and amoxicillin due to failed impurity specifications.

    Product
    triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2265-2014·2014-08-06

    GM Manufacturing Recalls BTI Lean Formula Dietary Supplements

    GM Manufacturing is recalling BTI Lean Formula dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

    Product
    BTI Lean Formula, 400cc HDPE Bottle
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1489-2014·2014-08-06

    FDA Recalls Unapproved Dermamedics and Therametics Baby's Relief Creams

    Dermamedics, L.L.C. is recalling specific lots of Dermamedics and Therametics Baby's Relief Calm and Repair Cream because the products are unapproved new drugs and misbranded.

    Product
    Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS 1016; and Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of BR008.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1493-2014·2014-08-06

    Dermamedics Calm and Correct Cream Recalled for Lack of FDA Approval

    Dermamedics, L.L.C. is recalling Calm and Correct Cream because the FDA determined the product is an unapproved new drug and misbranded.

    Product
    Dermamedics Calm and Correct Cream 2 oz. containers in the Dermamedics Post Medical Procedure Kit with a SKU number of SK1005
    Category
    Drug
    Distribution
    Distributed nationwide