The Recall Desk

Hazard

Specification Failure recalls

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

What the numbers show

Total
108
Critical
2
Severe
7
Most recent
2026-07-08

Of the 108 specification failure recalls we have scored against our rubric, 2 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (6%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all specification failure 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.

26–50 of 108

  • ModerateFDA (Drugs)·D-0353-2022·2022-01-12

    Wal-Fex Fexofenadine Tablets Recalled for Impurity Specifications

    Perrigo Company is recalling Wal-Fex Fexofenadine Hydrochloride 60mg tablets due to out-of-specification impurity levels detected during stability testing. The recall affects 4,536 containers distributed nationwide.

    Product
    Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle, Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic, NDC 0363-0903-62 UPC 3 11917 18625 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0339-2022·2022-01-12

    H.E.B Allergy Relief Fexofenadine tablets recalled for impurity specification failure

    Perrigo Company is recalling H.E.B Allergy Relief fexofenadine hydrochloride 60mg tablets nationwide due to failure of impurity specifications during stability testing.

    Product
    H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0329-2022·2022-01-12

    GoodSense Aller.Ease fexofenadine tablets recalled for impurity specification failure

    Perrigo Company PLC is recalling GoodSense Aller.Ease fexofenadine hydrochloride 60 mg tablets nationwide due to failed impurity and degradation specifications identified during stability testing.

    Product
    GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 count bottle, UPC 3 0113 0425 62 7; Made in the Czech Republic, Distributed by: Perrigo Allergan MI 49010.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0870-2021·2021-10-06

    Washington Homeopathic Products Homeopathic Medicine Fails Identity Testing

    Washington Homeopathic Products is recalling La Core LCL-2-0191 Blend homeopathic medicine due to out-of-specification test results in identification testing. The product was distributed nationwide.

    Product
    La Core LCL-2-0191 Blend, 149,980ml 20% Alcohol, WHP Homeopathic Medicine, For Manufacturing Only, Liter LCL-2-0191-Bend: 12% Lycopodium Clavatum 10X, 12% Carbo Vegetabilis 16X, 12% Natrum Muriaticum 9X, 12% Calcarea Carbonica 12X, 10% Hypothalamus 30X, 6% Pituitarum Posterium 12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0898-2021·2021-10-06

    Sodium Phenylbutyrate Powder Recalled for Impurity Specification Failures

    SigmaPharm Laboratories is recalling Sodium Phenylbutyrate Powder due to failed impurity and degradation specifications detected during routine testing. The affected lots are distributed nationwide.

    Product
    Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0891-2021·2021-10-06

    Aconitum Napellus Fear Homeopathic Medicine Recalled for Failed Identification Testing

    Washington Homeopathic Products is recalling 562 bottles of Aconitum Napellus Fear homeopathic medicine nationwide due to out-of-specification test results from identification testing.

    Product
    Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, 6X, 26X, 30X, packaged in 15mL containers, Aconitum Napellus Fear* 20% Alcohol HPUS: 6X, 10X, packaged in 30mL containers Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, 10X, 12X, 30X, packaged in 50mL containers Aconitum Napellus Fear
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0861-2021·2021-10-06

    Washington Homeopathic Products Haloderm Homeopathic Blend Recalled

    Washington Homeopathic Products is recalling Haloderm Homeopathic Blend due to out-of-specification test results from identification testing. The product was distributed nationwide.

    Product
    Haloderm Homeopathic Blend, For Manufacturing Use Only, 1,000 ml 20% Alcohol, Contains: Dulcamara 10x, Nitricum Acidum 12x, Thuja Occidentalis 10x, Antimonium Crudum 12x, Calcarea Cadbonica 12x, Silicea 12x, WHP Homeopathic Medicine, FOr Manufacturing Use Only. 1.957 kg Lactose
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0886-2021·2021-10-06

    ZTE-1035 Homeopathic Formula Recalled for Test Failures

    Washington Homeopathic Products is recalling ZTE-1035 Formula, an antimicrobial homeopathic combination product, due to out-of-specification test results for identification testing based on HPTLC analysis.

    Product
    ZTE-1035 Formula, Antimicrobial Combination, Contents 1006 ml, REMEDY: Arsenicum Album 10X, Baptista Tinctoria 10X, Phosphorus 10X, Arnica Montana 10X, Bryonia Alba 10X, Antimonium Crudum 10X, Iodium 10X, Lycopodium Clavatum 10X, Pulsatilla 10X, Berberis Vulgaris 10X, Glycyrrhiz
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0868-2021·2021-10-06

    Verbena Officinalis Homeopathic Pills Fail Identification Testing

    Washington Homeopathic Products is recalling 3 bottles of Verbena Officinalis 6X (Lot #29060, expiration 8/17/2026) distributed nationwide due to out-of-specification test results in identification testing.

    Product
    Verbena Officinalis 6X, Nervousness* Sucrose/Lactose Pills, Packaged 2 Dram, WHP Homeopathic Medicine, Washington Hoemopathis Producs, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0785-2021·2021-09-08

    Lidocaine Ointment USP 5% Recalled for Failed Viscosity Specifications

    Teligent Pharma is recalling Lidocaine Ointment USP 5% (114,456 tubes, Lots 15378 and 14418) distributed nationwide because certain lots do not meet viscosity specifications, as determined through routine testing.

    Product
    Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0728-2021·2021-08-25

    Avicel Microcrystalline Cellulose Recall for Out-of-Specification Conductivity

    DuPont Nutrition USA, Inc. is recalling Avicel microcrystalline cellulose (bulk PH101 NF, PH102 NF, PH200 NF) due to out-of-specification conductivity results. The product was distributed nationwide and internationally.

    Product
    Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0815-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0104-2021·2020-12-02

    Jubilant Cadista Recalls Clomipramine Hydrochloride Capsules Due to Specification Failure

    Jubilant Cadista Pharmaceuticals is recalling 4,416 bottles of clomipramine hydrochloride capsules because they failed tablet/capsule specifications.

    Product
    clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0594-2018·2018-02-14

    Hetero Labs Recalls Aripiprazole Tablets Due to CGMP Deviations

    Hetero Labs is recalling 3,000 bottles of Aripiprazole 10 mg tablets because the active ingredient did not meet all intended specifications.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2159-2017·2017-05-31

    MesaLabs Conductivity Standard Solution Recalled for Specification Failure

    Mesa Laboratories is recalling 9,900 units of Conductivity/TDS Calibrator Solution because the product failed to meet specifications. The solution is used for calibrating hemodialysis equipment and does not contact patients.

    Product
    MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02.0027). Polyethylene bottle Conductivity/TDS Calibrator solutions are a secondary standard solution used for the calibration of conductivity/TDS cells toget
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0955-2016·2016-06-08

    Lupin Recalls Ceftriaxone Sodium API Due to CGMP Deviations

    Lupin Pharmaceuticals Inc. is recalling Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient because intermediates failed specifications.

    Product
    Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 09
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1902-2015·2015-07-08

    FDA Recalls Palindrome Precision HSI Chronic Catheter Kits for Antimicrobial Issues

    The FDA is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1888-2015·2015-07-08

    Recall of Palindrome Precision SI Chronic Catheters Due to Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall covers 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1897-2015·2015-07-08

    Palindrome Precision HSI Chronic Catheter Kit Recalled for Antimicrobial Defect

    Covidien LLC is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1894-2015·2015-07-08

    Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1892-2015·2015-07-08

    Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1904-2015·2015-07-08

    Palindrome HSI Chronic Catheters Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.

    Product
    Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1908-2015·2015-07-08

    Covidien Recalls Chronic Catheters That May Not Meet Antimicrobial Specifications

    Covidien LLC is recalling specific lots of Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2015·2015-07-08

    Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Failure

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.

    Product
    Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063P
    Category
    Medical Device
    Distribution
    Distributed nationwide