The Recall Desk

Hazard

Out Of Specification recalls

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

What the numbers show

Total
261
Critical
2
Severe
6
Most recent
2026-07-29

Of the 261 out of specification recalls we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (2%) 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 out of specification 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.

201–225 of 261

  • ModerateFDA (Drugs)·D-0352-2022·2022-01-12

    Wal-Fex Fexofenadine Hydrochloride Tablets Recalled for Impurity Specification Failure

    Perrigo Company PLC is recalling Wal-Fex Fexofenadine Hydrochloride 180mg tablets distributed nationwide because impurity A levels exceeded specifications during stability testing.

    Product
    Wal-Fex Fexofenadine Hydrochloride tablets, 180mg/antihistamine, 24HR, packaged as a) 5 count bottle, NDC 0363-0600-13,UPC 3 11917 12267 0, b)30 count bottle, NDC 0363-0600-39 UPC 3 11917 16172 3 c) 90 count bottle, NDC 0363-0600-75 UPC 3 11917 12271 7 ; Distributed by Walgree
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0361-2022·2022-01-12

    Pregabalin Capsules Recalled for Out-of-Specification Manufacturing Defects

    Sun Pharmaceutical Industries is recalling Pregabalin 50 mg capsules due to out-of-specification results in particle size distribution and bulk density of the active pharmaceutical ingredient.

    Product
    PREGABALIN — PREGABALIN (PREGABALIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0336-2022·2022-01-12

    DG/health Aller.Ease Fexofenadine Tablets Recalled for Impurity

    Perrigo Company PLC is recalling DG/health Aller.Ease Fexofenadine Hydrochloride 180 mg tablets nationwide because they failed impurity specifications during stability testing.

    Product
    DG/health Aller.Ease, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 10 count bottle, Distributed by: Made in Czech Republic. Distributed by Dolgencorp, LLC, 100 Mission Ridge Goodlettsville, TN 37072. UPC 3 70030 65779 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0341-2022·2022-01-12

    Kroger Allergy Relief Fexofenadine Tablets Recalled for Impurity

    Perrigo Company is recalling Kroger Allergy Relief Fexofenadine Hydrochloride 60mg tablets due to an out-of-specification impurity detected during stability testing.

    Product
    Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinnati, Ohio 45202. Made in the Czech Republic, NDC 30142-555-53 UPC 0 41260 35588 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0328-2022·2022-01-12

    EQUALINE Fexofenadine Hydrochloride Tablets Recalled for Failed Impurity Testing

    Perrigo Company is recalling EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, due to impurity A exceeding specification limits during stability testing. The recalled products were distributed nationwide.

    Product
    EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22, UPC 0 41163 48067 4; b) 70 tablets per bottle, NDC 41163-571-01, UPC 0 41163 49847 1; Made in the Czech Republic, Distributed by: UNFI Providence, RI 02908.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0252-2022·2021-11-24

    REGARD Ear Tray recalled due to out-of-spec swabstick component

    ROi CPS LLC is recalling the REGARD Ear Tray because it contains a Povidone-Iodine swabstick component that does not meet specifications. The product was distributed in Florida, Louisiana, and Missouri.

    Product
    REGARD Ear Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0253-2022·2021-11-24

    REGARD Newborn Tray Recalled Due to Out-of-Spec Antiseptic Component

    ROi CPS LLC is recalling REGARD Newborn Trays (lot 86453F) distributed in FL, LA, and MO because some units contain a povidone-iodine swabstick component manufactured out of specifications.

    Product
    REGARD Newborn Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0255-2022·2021-11-24

    REGARD Ultrasound Trays Recalled for Out-of-Specification Swabstick Component

    ROi CPS LLC has recalled REGARD Ultrasound Trays because they contain out-of-specification Povidone-Iodine swabstick components. The 240 affected trays were distributed in Florida, Louisiana, and Missouri.

    Product
    REGARD Ultrasound Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0256-2022·2021-11-24

    REGARD Vitrectomy Tray Recalled for Out-of-Specification Antiseptic Component

    ROi CPS LLC is recalling 22 REGARD Vitrectomy Trays because the povidone-iodine swab component was manufactured out of specifications. Distribution was limited to Florida, Louisiana, and Missouri.

    Product
    REGARD Vitrectomy Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0233-2022·2021-11-24

    Flocinolone Acetonide 0.01% Topical Oil Recalled for Subpotency

    Amneal Pharmaceuticals is recalling Flocinolone Acetonide 0.01% Topical Oil due to an out-of-specification assay result indicating the drug is subpotent and may not deliver the intended therapeutic dose.

    Product
    Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0072-2022·2021-11-03

    ZEE+ Painaid ESF Tablets Recalled for Failed Stability Specifications

    Ultra Seal Corporation is recalling ZEE+ Painaid ESF Extra-Strength Formula tablets nationwide due to out-of-specification results for Salicylic Acid, an aspirin-related compound. The recall affects 50-count and 125-count packages with lot numbers AK-9547 (exp. April 22) and AK-9941 (exp. December 22).

    Product
    ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shi
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0022-2022·2021-10-27

    AirDuo Digihaler 232/14 Inhalation Powder Subpotent Recall

    Teva Pharmaceuticals is recalling AirDuo Digihaler 232/14 inhalation powder because some units do not deliver the correct amount of salmeterol as labeled.

    Product
    AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0858-2021·2021-10-06

    ZTE-105 Formula Gentle Detoxing Recall Due to Failed Identification Testing

    Washington Homeopathic Products is recalling ZTE-105 Formula Gentle Detoxing due to out-of-specification test results from identification testing. The product was distributed nationwide.

    Product
    ZTE-105 Formula Gentle Detoxing. Contents 1000 mL, RX Only, REMEDY: Bryoni Alba 10X, Chelidonium Majus 10X, Carduus Marianus 10X, Dolichos Pruriens 10X, Solidago Vigaurea 10X, Alfalfa 10X, Boldo 10X, Cynara Scolymus 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum M
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0873-2021·2021-10-06

    Washington Homeopathic Products Althaea 6X Bladder Pills Recalled

    Washington Homeopathic Products is recalling Althaea 6X Irritable Bladder Pills due to out-of-specification test results from identification testing. Ten bottles nationwide have been affected.

    Product
    Althaea 6X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 1 OZ, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0875-2021·2021-10-06

    Althaea 30X Homeopathic Pills Recalled for Failed Identification Testing

    Washington Homeopathic Products is recalling Althaea 30X Irritable Bladder sucrose/lactose pills (Lot #29377, expiration 8/17/2026) distributed nationwide because testing revealed out-of-specification results for product identification.

    Product
    Althaea 30X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0860-2021·2021-10-06

    Yeast Guard Blend Homeopathic Medicine Fails Identification Testing

    Washington Homeopathic Products is recalling Yeast Guard Blend homeopathic medicine because test results show it does not meet specification requirements for identification testing.

    Product
    Yeast Guard Blend, Calcarea Carbonica 6X, Collinsonia Canadensis 3X, Kali Muriaicum 3X, WHP Homeopathic Medicine, For Manufacturing Use Only. 1.957 kg Lactose, Manufactured by Wasington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0862-2021·2021-10-06

    Cedar Fever Drops Homeopathic Drug Recalled for Failed Identification Testing

    Washington Homeopathic Products is recalling Cedar Fever Drops due to out-of-specification test results from identification testing. The affected product was distributed nationwide.

    Product
    Cedar Fever Drops, 20% USP ALCOHOL, 30 mL, homeopathic drug for symptoms of cder allerges, Manufactured for Peoples RX, 3801 S Lamar, Austin, TX 78704. UPC 7 40640 64166 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0871-2021·2021-10-06

    Washington Homeopathic Products Kali Sulphuricum fails identification test

    Washington Homeopathic Products is recalling Kali Sulphuricum 3X homeopathic medicine nationwide because identification testing using HPTLC analysis produced out-of-specification results.

    Product
    Kali Sulphuricum 3X, 960ml 20% Alcohol, WHP Homeopathic Medicine, For Manufacturing Use Only. Manufactured by Washington Homeopathic Products 260JR hawvermale Way Berkeley Springs WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0877-2021·2021-10-06

    Washington Homeopathic Products Quebracho 4C Fever Medicine Recall

    Washington Homeopathic Products is recalling Quebracho 4C Fever homeopathic medicine (Lot #28930, expiration 8/17/2026) distributed nationwide due to out-of-specification test results from identification testing.

    Product
    Quebracho 4C, Fever*, 20% Alcohol, Packaged as 100ml, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0888-2021·2021-10-06

    ZTE 1015 Formula Homeopathic Product Recall for Out-of-Specification Test Results

    Washington Homeopathic Products is recalling ZTE 1015 Formula due to out-of-specification test results from identification testing. The product failed HPTLC analysis.

    Product
    ZTE 1015 Formula, Contents 1000 ml, For Manufacturing Use only, REMEDY: Argentum Nitricum 10X, Rhus Toxicodendron 10X, Aurum Metallicum 10X, Iris Versicolor 10X, Lycopodium Clavatum 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0874-2021·2021-10-06

    Althaea 6X Irritable Bladder Homeopathic Drops Recalled for Failed Identification Testing

    Washington Homeopathic Products is recalling Althaea 6X Irritable Bladder drops (Lot #29377) distributed nationwide because identification testing via HPTLC analysis produced out-of-specification results.

    Product
    Althaea 6X, Iritable Bladder* 20% Alcohol, Drops, packaged as 15 ml, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0863-2021·2021-10-06

    Althaea Officinalis 4X Homeopathic Medicine Recalled for Failed Identification Testing

    Washington Homeopathic Products is recalling Althaea Officinalis 4X, Iritable Bladder homeopathic medicine (Lot # 29377, Exp 8/17/2026) distributed nationwide because testing results failed to meet specifications for product identification.

    Product
    Althaea Officinalis 4X, Iritable Bladder* packaged as Sucrose/Lactose Pills, 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0895-2021·2021-10-06

    Washington Homeopathic Products Aconitum Napellus 12X Fear Recall

    Washington Homeopathic Products is recalling Aconitum Napellus 12X Fear homeopathic medicine due to out-of-specification test results from identification testing.

    Product
    Aconitum Napellus 12X Fear* 87% Alcohol HPUS: packaged in 30 mL containers; WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0887-2021·2021-10-06

    ZTE 1013 Formula Antimicrobial Homeopathic Product Recall

    Washington Homeopathic Products is recalling ZTE 1013 Formula Antimicrobial (1000 ml, Lot # 25738) distributed nationwide because testing identified out-of-specification results during identification analysis.

    Product
    ZTE 1013 Formula Antimicrobial - F&M , Contents 1000 ml, REMEDY: Bryonia Alba 10X, Antimonium Crudum 10X, Iodium 10X, Lycopodium Clavatum 10X, Pulsatilla 10X, Berberus Vulgaris 10X, Glycyrrhiza Clabra 10X, Condurango 10X, Ginco Biloba 10X, Chromium Sulphuricum 10X, Manganum Metal
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0869-2021·2021-10-06

    Viola Odorata Homeopathic Medicine Recall for Failed Identification Testing

    Washington Homeopathic Products is recalling Viola Odorata homeopathic medicine (Lot #29057, expiration 8/17/2026) distributed nationwide because identification testing using HPTLC analysis returned out-of-specification results.

    Product
    Viola Odorata 4X, 10X, 12X, Bee Stings*, Sucrose/Lactose Pills, 4X Packaged in a) 2 Dram; 10X Packaged in b) 2 Dram; 12X Packaged in c) 2 Dram; d) 4 Dram; WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.
    Category
    Drug
    Distribution
    Distributed nationwide