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.

9826–9850 of 21595

  • ModerateFDA (Drugs)·D-0054-2019·2018-10-24

    TopCare Saline Nasal Gel Recalled for Manufacturing Quality Deviations

    Product Quest Manufacturing LLC is recalling TopCare Saline Nasal Gel with Soothing Aloe due to manufacturing conditions that could impact product quality.

    Product
    TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed By Topco Associates LLC, Elk Grove Village, IL 60007, UPC 0 36800 42146 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0060-2019·2018-10-24

    Walgreens Nasal Decongestant Recalled for Manufacturing Quality Deviations

    Product Quest Manufacturing LLC is recalling Walgreens Nasal Spray (Oxymetazoline HCl 0.05%) due to CGMP deviations that could impact product quality.

    Product
    Walgreens, Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour, 0.75 FL OZ (22 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, UPC 3 11917 18622 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0145-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 16 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and two foreign countries.

    Product
    Affixus Hip Fracture Nail Left 125 9 mm x 260 mm, Item Number 814409260 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0169-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect

    Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0030-2019·2018-10-24

    CVS Health Saline Nasal Mist Recalled for Quality Control Issues

    Product Quest Manufacturing LLC is recalling CVS Health Sterile Saline Nasal Mist due to manufacturing deviations that could impact product quality.

    Product
    CVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9%, packaged in a) Net Wt. 1.52 OZ (43 g) can UPC 0 50428 37079 7 Product #896831; b) Net Wt. 4.25 OZ (120 g) can UPC 0 50428 36124 5; c) Children's Net Wt. 2 OZ (57 g) can UPC 0 50428 58685 3 Pro
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0073-2019·2018-10-24

    CVS Triple Antibiotic Ointment Spray Recalled for Low Bacitracin Zinc Levels

    Product Quest Manufacturing LLC is recalling CVS Health Triple Antibiotic Ointment Spray because the bacitracin zinc ingredient was found to be subpotent.

    Product
    CVS Health, Original Strength, Triple Antibiotic Ointment Spray (bacitracin zinc 400 units, neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units per gram), 2 OZ (57 g) can, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Product#957603, UPC 0 50428 29
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0031-2019·2018-10-24

    Tropical Nut & Fruit Company Recalls United Fitness Mix Due to Maggots

    Tropical Nut & Fruit Company is recalling United Fitness Mix 25LB boxes after a customer reported finding maggots in the product.

    Product
    United Fitness Mix 25LB box, Almonds, Walnuts, Pumpkin Seeds, Cashews, Blueberries***Manufactured or packed in a facility that uses tree nuts, peanuts, milk, soy, and wheat products" Distributed by: Truly Good Foods, Orlando, FL 32811 UPC 0 94154 00803 7
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0059-2019·2018-10-24

    Product Quest Recalls Best Choice Saline Nasal Spray for Quality Deviations

    Product Quest Manufacturing LLC is recalling Best Choice Saline Nasal Spray because it was manufactured under conditions that could impact product quality.

    Product
    Best Choice, SALINE Nasal Spray (Sodium Chloride 0.65% Phenylcarbinol & Benzalkonium Chloride as Preservatives), 1.5 FL OZ (44 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 58487 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0047-2019·2018-10-24

    FDA Recalls Premier Value Nasal Decongestant Spray Due to Quality Concerns

    Product Quest Manufacturing LLC is recalling Premier Value Nasal Decongestant Nasal Spray because it was manufactured under conditions that could impact product quality.

    Product
    Premier Value, Nasal Decongestant, Nasal Spray (oxymetazoline HCl 0.05%), Regular Strength, 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-316-03, UPC 8 40986 01516 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0078-2019·2018-10-24

    Rexall Nasal Spray Recalled for Manufacturing Quality Deviations

    Product Quest Manufacturing LLC is recalling Rexall Extra Moisturizing No Drip Nasal Spray due to manufacturing conditions that could impact product quality.

    Product
    Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48 pk. (12687901)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0024-2019·2018-10-24

    Humco Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels

    Humco Holding Group, Inc. is recalling 10 kilograms of Thyroid, USP powder because it has inconsistent levels of levothyroxine and liothyronine.

    Product
    Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain Liothyronine 29.2 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 0395-6580-43 Packaged by: Humco Texarkana, TX 75501 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0038-2019·2018-10-24

    Product Quest Recalls Saline Nasal Mist Due to Manufacturing Deviations

    Product Quest Manufacturing LLC is recalling 46,056 cans of FAMILY wellness Sterile Saline Nasal Mist because they were manufactured under conditions that could impact product quality.

    Product
    FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium Chloride Solution), 4.25 FL OZ (126 mL) can, Distributed by: Midwood Brands, LLC, 10611 Monroe Rd., Matthews, NC 28105, UPC 0 32251 11617 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0046-2019·2018-10-24

    Premier Value Sterile Saline Nasal Mist Recalled for Quality Concerns

    Product Quest Manufacturing LLC is recalling 10,584 cans of Premier Value Sterile Saline Nasal Mist due to manufacturing deviations that could impact product quality.

    Product
    Premier Value, Sterile Saline Nasal Mist, Saline Nasal Moisturizer (0.9% Sodium Chloride) Solution, 4.25 FL OZ (126 mL) can, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 8 40986 02998 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0104-2019·2018-10-24

    Valeris Medical Apollo Medial Suture Anchor Recalled for Mislabeling

    Valeris Medical is recalling 75 units of Apollo Medial Suture Anchors because the product was mislabeled as containing the incorrect type of suture.

    Product
    Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1) PEEK Screw, (1) #2 ForceBraid Blue, and (1) #2 ForceBraid White, 5 packages per container, Sterile, Rx. The firm name on the label is Valeris Medical, Marietta, GA.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0075-2019·2018-10-24

    Rhinall Nasal Decongestant Spray Recalled for Manufacturing Quality Deviations

    Product Quest Manufacturing LLC is recalling Rhinall Nasal Decongestant Nasal Spray due to manufacturing conditions that could impact product quality.

    Product
    Rhinall Nasal Decongestant Nasal Spray (phenylephrine HCl), 0.25%, 1 1/3 Fl Oz. (40 ml), Manufactured for: Scherer Laboratories, Inc., Atlanta, GA 30339.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0158-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 85 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0142-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling nine Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the products were opened in surgery.

    Product
    Affixus Hip Fracture Nail Right 125 13 mm x 360 mm, Item Number 814313360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0133-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 12 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0151-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect

    Zimmer Biomet is recalling 15 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers US and foreign distribution.

    Product
    Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0051-2019·2018-10-24

    Rite Aid Nasal Spray Recalled for Manufacturing Quality Deviations

    Product Quest Manufacturing LLC is recalling Rite Aid nasal spray due to manufacturing conditions that could impact product quality.

    Product
    Rite Aid Pharmacy, nasal relief NO DRIP PUMP SPRAY nasal spray, (oxymetazoline hydrochloride 0.05%), 12 Hour, 1 FL OZ (30 mL) bottle, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 31412 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0162-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0161-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 44 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers US and foreign distribution.

    Product
    Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0109-2019·2018-10-24

    FDA Recalls Ambu Aura40 Reusable Laryngeal Masks Due to Labeling Error

    Besmed Health Business Corporation is recalling Ambu Aura40 Standard reusable laryngeal masks because they are packaged in pouches marked as single-use.

    Product
    Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0032-2019·2018-10-24

    CVS Health Sterile Saline Nasal Mist Recalled for Quality Deviations

    Product Quest Manufacturing LLC is recalling CVS Health Sterile Saline Nasal Mist due to manufacturing deviations that could impact product quality.

    Product
    CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, 3.0%, 4.25 OZ (126 g) can, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 41854 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0032-2019·2018-10-24

    Coca-Cola Bottling Company Recalls Caffeine Free Diet Coke Due to Plastic Material

    Coca-Cola Bottling Company is recalling Caffeine Free Diet Coke 12 oz bottles because the product contains plastic material. The recall affects shipments to six states.

    Product
    CAFFEINE FREE Diet Coke 12 FL OZ (355 ml) CONTAINS PHENYLALANINE CAFFEINE FREE THE COCA-COLA COMPANY FOR CONSUMER INFORMATION CALL 1-800-438-2653 UPC 0 496130 1
    Category
    Food
    Distribution
    6 states