The Recall Desk

Hazard

Out Of Specification recalls

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

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.

126–150 of 170

  • SevereFDA (Drugs)·D-0992-2022·2022-06-08

    Anagrelide Capsules Recalled Due to Failed Dissolution Specifications

    Teva Pharmaceuticals is recalling Anagrelide Capsules USP 0.5 mg nationwide due to failed dissolution specifications discovered during stability testing. The recall involves lot GD01090 (expired May 2022).

    Product
    Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0970-2022·2022-06-08

    Equate Tartar Control Plus Mouthwash Recalled for Out-of-Specification Formula

    Walmart is recalling Equate Tartar Control Plus mouthwash from certain lots because they were found to have active ingredients outside the approved specification.

    Product
    Equate Tartar Control Plus (Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%) Antiseptic Mouthrise Plus, Antigingivitis/Antiplaque, Blue Mint, 1.5 Liter (50.7 FL OZ) bottle, Distributed By: Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 14800
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0558-2022·2022-02-23

    Diazepam Oral Solution Recalled for Failed Impurity Specifications

    Lannett Company is recalling Diazepam Oral Solution (Concentrate) 5 mg/mL due to out-of-specification results for related substances, indicating failed impurities and degradation testing.

    Product
    Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1768-36.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0586-2022·2022-02-16

    Diagnostic Control Microorganism Recalled for Incorrect Test Results

    Diagnostic control microorganisms manufactured by Microbiologics Inc are recalled for returning incorrect antibiotic susceptibility test results. These controls failed quality specifications and could cause inaccurate lab test results.

    Product
    LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0520-2022·2022-02-09

    Tretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications

    Teva Pharmaceuticals USA is recalling Tretinoin Capsules 10 mg due to failed dissolution specifications and out-of-specification test results. Approximately 1,175 bottles distributed nationwide may not dissolve properly.

    Product
    Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02
    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-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-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-0343-2022·2022-01-12

    Meijer Fexofenadine Hydrochloride Allergy Relief Tablets Recalled

    Meijer allergy relief tablets containing fexofenadine hydrochloride are being recalled nationwide due to out-of-specification impurity results found during stability testing.

    Product
    Meijer allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 41250-060-22 UPC 7 60236 18716 5; b) 30 count bottle, NDC 41250-060-39, UPC 7 60236 18717 2; c) 45 count bottle, NDC 41250-060-95, UPC 7 60236 18732 5; Made
    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
  • ModerateFDA (Drugs)·D-0335-2022·2022-01-12

    CVS Allergy Relief Fexofenadine Tablets Recalled for Impurity

    CVS Allergy Relief Fexofenadine Hydrochloride Tablets 60 mg are being recalled because stability testing found an out-of-specification result for impurity A. The recall affects approximately 138,144 containers distributed nationwide.

    Product
    CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 60 mg Antihistamine, 12HR, packaged as a) 12 count bottle, NDC 59779-425-53, UPC 0 50428 25414 1; b)24 count bottle, NDC 59779-425-62, UPC 0 50428 53435 9; Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02
    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-0356-2022·2022-01-12

    CVS Allergy Relief Fexofenadine Tablets Recalled for Impurity Specifications

    Perrigo Company is recalling CVS Allergy Relief Fexofenadine Hydrochloride 180 mg tablets due to an out-of-specification impurity result found during stability testing. The recall affects one lot distributed nationwide.

    Product
    CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4
    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 (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
  • 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
  • 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-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-0894-2021·2021-10-06

    Aconitum nap Fear Homeopathic Medicine Recalled for Failed Product Identification Testing

    Washington Homeopathic Products is recalling Aconitum nap Fear 20% Alcohol homeopathic medicine (Lot #26198) distributed nationwide due to out-of-specification test results from HPTLC identification analysis.

    Product
    Aconitum nap Fear* 20% Alcohol HPUS: 6X, packaged in 50mL & 8 oz containers Aconitum nap Fear* 20% Alcohol HPUS: 7X, 12X, packaged in 15mL containers WHP Homeopathic Medicine, Washington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0884-2021·2021-10-06

    Z-1070 Formula Anxioheal Homeopathic Medicine Recall for Testing

    Washington Homeopathic Products, Inc. is recalling Z-1070 Formula Anxioheal, a 1000ml homeopathic remedy containing 20% alcohol, due to out-of-specification test results from HPTLC identification testing. The product was distributed nationwide.

    Product
    Z-1070 Formula Anxioheal. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY:Causticum 30X, Conium Maculatum 8X, Conium Maculatum 12X, Crataegus Oxyacantha 12X, Crataegus Oxyacantha 30X, Ignatia Amara 24X, Lycopus Virginicus 12X, Phosphoricu
    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-0889-2021·2021-10-06

    Strophanthus Hisp 30X Homeopathic Medicine Fails Identification Test

    Washington Homeopathic Products is recalling 91 bottles of Strophanthus hisp 30X for Hives due to failed identification testing. The product did not meet specifications in HPTLC analysis and was distributed nationwide.

    Product
    Strophanthus hisp 30X, Hives*, 20% Alcohol, Packaged in (a) 15 mL, UPC 7 40640 47553 9; (b) 30mL UPC 7 40640 47557 7; (c) 100mL, UPC 7 40640 47565 2; WHP Homeopathic Mecicine, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide