The Recall Desk

Hazard

Lack Of Efficacy recalls

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

What the numbers show

Total
16
Critical
2
Severe
9
Most recent
2021-04-21

Of the 16 lack of efficacy recalls we have scored against our rubric, 2 (13%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (56%) 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 lack of efficacy 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.

1–16 of 16

  • CriticalFDA (Drugs)·D-0614-2021·2021-04-21

    Novo Nordisk Recalls Levemir Insulin Pens Due to Temperature Abuse

    Novo Nordisk is recalling Levemir FlexTouch insulin pens stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    LEVEMIR — LEVEMIR (INSULIN DETEMIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0621-2021·2021-04-21

    Novo Nordisk Recalls TRESIBA Insulin Pens Due to Temperature Abuse

    Novo Nordisk is recalling specific lots of TRESIBA insulin pens because they were stored below 32°F, which may reduce efficacy and damage the device.

    Product
    TRESIBA — TRESIBA (INSULIN DEGLUDEC)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0620-2021·2021-04-21

    Novo Nordisk Recalls TRESIBA Insulin Samples Due to Temperature Abuse

    Novo Nordisk is recalling TRESIBA (insulin degludec) samples stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    TRESIBA — TRESIBA (INSULIN DEGLUDEC)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0612-2021·2021-04-21

    Novo Nordisk Recalls Fiasp Insulin Due to Temperature Abuse

    Novo Nordisk is recalling Fiasp insulin cartridges stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    FIASP — FIASP (INSULIN ASPART INJECTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0611-2021·2021-04-21

    Novo Nordisk Recalls Fiasp Insulin Pens Due to Temperature Abuse

    Novo Nordisk is recalling Fiasp insulin pen samples stored below 32°F. The temperature abuse may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    FIASP — FIASP (INSULIN ASPART INJECTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0619-2021·2021-04-21

    Novo Nordisk Recalls TRESIBA Insulin Pens Due to Temperature Abuse

    Novo Nordisk is recalling TRESIBA (insulin degludec) prefilled pens because they were stored below 32°F, which may reduce efficacy and damage the device.

    Product
    TRESIBA — TRESIBA (INSULIN DEGLUDEC)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0613-2021·2021-04-21

    Novo Nordisk Recalls Fiasp Insulin Samples Due to Temperature Abuse

    Novo Nordisk is recalling Fiasp (insulin aspart injection) samples stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    FIASP — FIASP (INSULIN ASPART INJECTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0623-2021·2021-04-21

    Novo Nordisk Recalls Xultophy 100/3.6 Due to Temperature Abuse

    Novo Nordisk is recalling Xultophy 100/3.6 samples stored below 32°F. The temperature abuse may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    XULTOPHY 100/3.6 — XULTOPHY 100/3.6 (INSULIN DEGLUDEC AND LIRAGLUTIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0615-2021·2021-04-21

    Novo Nordisk Recalls Insulin Diluting Medium Due to Temperature Abuse

    Novo Nordisk is recalling specific samples of Insulin Diluting Medium for NovoLog because they were stored below 32°F, potentially causing lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    INSULIN DILUTING MEDIUM FOR NOVOLOG — INSULIN DILUTING MEDIUM FOR NOVOLOG (WATER INJECTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0617-2021·2021-04-21

    Novo Nordisk Recalls OZEMPIC Injection Pens Due to Temperature Abuse

    Novo Nordisk is recalling OZEMPIC sample pens stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-4132-90 (Pen), NDC 0169-4132-97 (Kit)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0622-2021·2021-04-21

    Novo Nordisk Recalls Victoza Injection Due to Temperature Abuse

    Novo Nordisk is recalling specific lots of Victoza (liraglutide) injection because they were stored below 32°F, potentially causing loss of efficacy and device damage.

    Product
    VICTOZA — VICTOZA (LIRAGLUTIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0618-2021·2021-04-21

    Novo Nordisk Recalls Saxenda Injection Samples Due to Temperature Abuse

    Novo Nordisk is recalling Saxenda (liraglutide) injection samples that were stored below 32°F. The temperature abuse may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    SAXENDA — SAXENDA (LIRAGLUTIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0003-2019·2018-09-26

    QuVa Pharma Recalls Subpotent Norepinephrine IV Bags Nationwide

    QuVa Pharma is recalling 528 bags of Norepinephrine 4 mg in 5% Dextrose because the active ingredient may be missing. The product was distributed to hospitals nationwide.

    Product
    Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0528-2018·2018-02-14

    Angiodynamics Recalls Accu2i Microwave Tissue Ablation Applicators

    Angiodynamics, Inc. is recalling Accu2i pMTA Microwave Tissue Ablation Applicators that may fail to deliver energy due to coolant ingress.

    Product
    Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (UPN) H7879006020, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperativ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0694-2017·2017-05-10

    P & L Development Recalls Subpotent Diphenhydramine HCl Allergy Softgels

    P & L Development is recalling 369,012 cartons of diphenhydramine HCl allergy softgels sold under multiple brands due to low potency test results.

    Product
    Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24, UPC 0-36800-39134-5; (b) Rexall Since 1903 Aller
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1693-2012·2012-10-03

    Actavis Recalls Fentanyl Transdermal Systems Due to Subpotent Product

    Actavis is recalling Fentanyl Transdermal Systems, 100 mcg/h, because some patches may not contain fentanyl gel. The recall covers 98,088 cartons distributed nationwide.

    Product
    Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (NDC 0591-3214-72 (Carton)), Manufactured by Watson laboratories Inc., Corona, CA,
    Category
    Drug
    Distribution
    Distributed nationwide