The Recall Desk

Hazard

Quality Deviation recalls

42 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
42
Critical
0
Severe
5
Most recent
2021-06-02

Of the 42 quality deviation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (12%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all quality deviation recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 42

  • ModerateFDA (Drugs)·D-0478-2021·2021-06-02

    Cardinal Health Recalls Advair HFA Inhalers Due to Temperature Excursions

    Cardinal Health is recalling 297 units of Advair HFA inhalers due to intermittent temperature exposure during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0552-2021·2021-06-02

    Cardinal Health Recalls LYRICA Capsules Due to Temperature Excursions

    Cardinal Health is recalling 49 bottles of LYRICA (pregabalin) 200mg capsules due to intermittent exposure to temperature excursions during storage.

    Product
    LYRICA (pregabalin) capsules, 200mg 90-count bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, MADE IN SINGAPORE
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1586-2019·2019-08-14

    Glenmark Recalls Mometasone Furoate Cream Due to Gritty Texture Complaints

    Glenmark Pharmaceuticals is recalling Mometasone Furoate Cream 0.1% because patients reported the product felt gritty. The recall covers 15g and 45g tubes distributed nationwide.

    Product
    MOMETASONE FUROATE — MOMETASONE FUROATE (MOMETASONE FUROATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0063-2019·2018-10-24

    Walgreens Anefrin Nasal Spray Recalled for Manufacturing Quality Issues

    Product Quest Manufacturing LLC is recalling 355,056 bottles of Walgreens Anefrin Nasal Spray due to manufacturing conditions that could impact product quality.

    Product
    Walgreens, NO DRIP, Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Original, 12 Hour, Maximum Strength, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015,NDC 0363-7005-01, UPC 3 11917 18537 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0062-2019·2018-10-24

    Product Quest Recalls Well at Walgreens Sinus Relief Mist for Quality Issues

    Product Quest Manufacturing LLC is recalling Well at Walgreens ULTRA FINE Sinus Relief Mist due to manufacturing deviations that could impact product quality.

    Product
    Well at Walgreens, ULTRA FINE Sinus Relief Mist (Oxymetazoline HCl 0.05%) bottle, Sinus Reliever, Nasal Decongestant, 12 Hour Pump Mist, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7000-01, UPC 3 11917 18535 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0039-2019·2018-10-24

    Harmon Face Values Saline Nasal Gel Recalled for Quality Deviations

    Product Quest Manufacturing LLC is recalling Harmon Face Values Saline Nasal Gel with Soothing Aloe due to manufacturing deviations that could impact product quality.

    Product
    Harmon Face Values, Saline Nasal Gel with Soothing Aloe, 0.5 oz. (14.1 g) tube, Distributed by: Harmon Stores, Inc., Union, NJ 07083 USA, UPC 7 27510 00474 7 .
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0029-2019·2018-10-24

    Product Quest Recalls CareOne Saline Nasal Gel Due to Quality Concerns

    Product Quest Manufacturing LLC is recalling CareOne Saline Nasal Gel With Soothing Aloe because it was manufactured under conditions that could impact product quality.

    Product
    CareOne, Saline Nasal Gel With Soothing Aloe, Net Wt. 0.5 OZ (14.1 g) tube, Distributed by Foodhold U.S.A., LLC., Landover, MD 20785, 1-877-846-9949, UPC 3 41520 00175 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0052-2019·2018-10-24

    Thayers Saline Nasal Mist Recalled for Manufacturing Quality Deviations

    Product Quest Manufacturing is recalling Thayers Saline Nasal Mist due to manufacturing conditions that could impact product quality.

    Product
    Thayers Natural Remedies, Saline Nasal Mist, Allergy & Sinus Relief, Slippery Elm, 3 FL OZ (89 mL) can, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00659 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0040-2019·2018-10-24

    Harmon Face Values Saline Nasal Spray Recalled for Quality Deviations

    Product Quest Manufacturing LLC is recalling Harmon Face Values Saline Nasal Spray due to manufacturing deviations that could impact product quality.

    Product
    Harmon Face Values, Saline Nasal Spray (sodium chloride), 0.65%, packaged as a) 1.5 FL OZ (44 mL) bottle UPC 7 27510 00501 0; b) 3 FL OZ (88 mL) bottle UPC 7 27510 00502 7, Distributed by Harmon Stores, Inc., Union, NJ 07083 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0034-2019·2018-10-24

    CVS Saline Nasal Gel Recalled for Manufacturing Quality Deviations

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

    Product
    CVS Health, Saline Nasal Gel with Soothing Aloe, packaged as a) Baby Net Wt. 0.5 OZ (14.2 g) tube UPC 0 50428 58392 0 Product #282476; and b) Net Wt. 0.5 OZ tube (14.2 g) UPC 0 50428 31746 4 Product #896071; Distributed by CVS Pharmacy, Inc,. One CVS Drive, Woonsocket, RI 02895.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0064-2019·2018-10-24

    Walgreens Severe Anefrin Nasal Spray Recalled for Quality Deviations

    Product Quest Manufacturing LLC is recalling Walgreens NO DRIP Severe Anefrin Nasal Spray due to manufacturing deviations that could impact product quality.

    Product
    Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour + Menthol, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7001-01, UPC 3 11917 18536 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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-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-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-0048-2019·2018-10-24

    Premier Value Saline Nasal Spray Recalled for Quality Concerns

    Product Quest Manufacturing LLC is recalling Premier Value Saline Nasal Spray due to manufacturing deviations that could impact product quality.

    Product
    Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL) bottle NDC 68016-388-00 UPC 8 40986 01483 3; b) 1.5 FL OZ (44 mL) bottle NDC 68016-466-00 UPC 8 40986 01482 6, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca R
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0043-2019·2018-10-24

    Product Quest Recalls HuMist Saline Nasal Mist Due to Manufacturing Deviations

    Product Quest Manufacturing LLC is recalling HuMist Saline Nasal Mist bottles due to manufacturing deviations that could impact product quality.

    Product
    HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer Labs International, LLC. 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02742 68045 9 .
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0057-2019·2018-10-24

    Product Quest Recalls Best Choice Nasal Spray Due to Manufacturing Deviations

    Product Quest Manufacturing LLC is recalling Best Choice 12 Hour Sinus Relief Nasal Spray because it was manufactured under conditions that could impact product quality.

    Product
    Best Choice, 12 Hour Sinus Relief, Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co,. 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 63684 7.
    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 (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 (Drugs)·D-0028-2019·2018-10-24

    Rhinall Nasal Decongestant Recalled for Manufacturing Quality Deviations

    Product Quest Manufacturing LLC is recalling Rhinall nasal drops due to CGMP deviations that could impact product quality.

    Product
    Rhinall (phenylephrine hydrochloride) Nasal Decongestant Nose Drops, 0.25%, 1 FL OZ (30 mL) bottle, Distributed by: Scherer Labs International, LLC., 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02747 52531 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0035-2019·2018-10-24

    CVS Health Saline Nasal Spray Recalled for Manufacturing Deviations

    Product Quest Manufacturing LLC is recalling 552 bottles of CVS Health Saline Nasal Spray due to CGMP deviations that could impact product quality.

    Product
    CVS Health, Saline Nasal Spray, 1.5 FL OZ bottle, Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, Product #277790.
    Category
    Drug
    Distribution
    Distributed nationwide