The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

3776–3800 of 4878

  • SevereFDA (Food)·F-0919-2022·2022-03-16

    Abbott Similac Human Milk Fortifier Recalled Due to Pathogen Risk

    Abbott Similac Human Milk Fortifier pouches are recalled due to potential Cronobacter sakazakii and Salmonella Newport contamination. The recall affects infants who may have received contaminated product.

    Product
    Abbott Similac Human Milk Fortifier 0.9g Pouch / Sachet, 50 Pouch / Sachet per retail unit. 3 retail units per case Item numbers: 54598 5459813 5459814 5459820 5459886 6771009 Retail UPCs: 70074545998 070074545998 055325545996 070074109404 070074103297 07007467
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0952-2022·2022-03-16

    Abbott EleCare Jr Amino Acid Powder Recalled for Pathogenic Bacteria

    Abbott EleCare Jr Amino Acid-Based Nutrition Powder (banana) is recalled due to consumer complaints of Cronobacter sakazakii or Salmonella Newport in infants, with pathogen evidence in the manufacturing facility.

    Product
    Abbott EleCare Jr Amino Acid-Based Nutrition Powder Banana 14.1oz. can. 6 cans per case. Item numbers: 66275 Retail UPCs: 070074662763
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0936-2022·2022-03-16

    Abbott Alimentum infant formula recalled due to Cronobacter sakazakii contamination

    Abbott Laboratories is recalling Alimentum infant formula due to Cronobacter sakazakii detected in the manufacturing facility and consumer complaints of Cronobacter and Salmonella Newport in infants.

    Product
    Abbott Alimentum, Abbott Similac Alimentum, Abbott Similac Alimentum HMO, Abbott Alimentum Similac, Abbott Similac Gold Alimentum HMO 400g can. 6 cans per case. Item numbers: 674845 6748406 6748408 6748412 6748425 6748426 6748430 6748453 6748484 Retail UPCs: 00
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0949-2022·2022-03-16

    Abbott EleCare Infant Formula Recalled for Potential Cronobacter and Salmonella

    Abbott Laboratories is recalling EleCare infant formula nationwide and worldwide due to potential contamination with Cronobacter sakazakii and Salmonella Newport. Consumer complaints related to these pathogens have been received involving infants.

    Product
    Abbott EleCare Amino Acid-Based Powder Infant Formula with Iron 14.1oz. can, Abbott Elecare 400g. can, Abbott Elecare Unflavored 14.1oz. can. 6 cans per case. Item numbers: 55251 5525157 5525189 Retail UPCs: 070074535111 070074116297 070074119854
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0935-2022·2022-03-16

    Abbott Similac infant formula recalled due to bacterial contamination

    Abbott is recalling multiple Similac infant formula products due to potential contamination with Cronobacter sakazakii and Salmonella Newport. These pathogens pose serious health risks to infants.

    Product
    Abbott Similac Advance Infant Formula with Iron 12.4oz. can, 23.2oz. plastic jar, 20.6oz. plastic jar. 6 units per case. Abbott Similac Pro-Advance 34oz. plastic jar. 6 jars per case. Item numbers: 53359 68084 5595776 6748701 Retail UPCs: 070074533605 07007468
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0718-2022·2022-03-16

    FDA Recalls COVID-19 Antibody Test Kits for Lacking Regulatory Authorization

    Lusys Laboratories is recalling 33,955 COVID-19 antibody test kits distributed across the US and internationally because the product lacks FDA authorization, clearance, or approval for marketing or use.

    Product
    COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0717-2022·2022-03-16

    Luscient Diagnostics COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization

    Lusys Laboratories' Luscient Diagnostics COVID-19 Antigen Test Kits are being recalled because they lack FDA authorization. The kits were not approved, cleared, or authorized for distribution in the United States.

    Product
    Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0942-2022·2022-03-16

    Abbott Similac Alimentum infant formula recalled for Cronobacter and Salmonella

    Abbott Laboratories is recalling Similac Alimentum infant formula due to contamination with Cronobacter sakazakii and Salmonella Newport. The recall involves 34,704 cases distributed nationwide and worldwide following consumer complaints and manufacturing facility testing.

    Product
    Abbott Similac Alimentum with 2'-FL HMO, Abbott Similac Alimentum HMO, Abbott Alimentum HMO, Abbott Similac Alimentum infant formula, Abbott Similac Alimentum 400g can. 6 cans per case. Item numbers: 6749111 6749117 6749118 6749124 6749134 6749166 6749181 6749199
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0927-2022·2022-03-16

    Abbott Similac Alimentum Infant Formula Recalled for Bacterial Contamination

    Abbott Laboratories recalls Similac Alimentum Infant Formula with Iron due to potential Cronobacter sakazakii and Salmonella Newport contamination. Consumer complaints related to infections in infants and manufacturing facility contamination prompted the FDA Class I recall.

    Product
    Abbott Similac Alimentum Infant Formula with Iron 12oz. can. 6 jars per case; 19.8oz. can. 4 cans per case; 7oz. can. 6 cans per case Item numbers: 64715 64717 64719 Retail UPCs: 070074647128 070074647166 070074647180
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0827-2022·2022-03-16

    Taiwan Best Quality Enoki Mushrooms Recalled for Listeria Contamination

    Jan Fruits, Inc. is recalling Taiwan Best Quality Enoki Natural Mushrooms due to Listeria monocytogenes contamination found by California Department of Public Health. Approximately 617 cases were distributed in California.

    Product
    Taiwan Best Quality Enoki Natural Mushrooms, Premium 200g/7.5 oz. clear plastic package. 50 pcs per box. Manufacturer: Changhua County Mushroom Production Cooperative; Distributed by Jan Fruits. UPC: 8 51084 00835 8
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0946-2022·2022-03-16

    Abbott Similac Organic Infant Formula recalled for Cronobacter and Salmonella

    Abbott Similac Organic with A2 Milk Infant Formula is being recalled following consumer complaints related to Cronobacter sakazakii and Salmonella Newport in infants, plus evidence of Cronobacter in the manufacturing facility.

    Product
    Abbott Similac Organic with A2 Milk Infant Formula with Iron 8oz. and 7oz. can. 6 cans per case. 20.6oz. plastic jar. 4 jars per case. Item numbers: 67904 68016 68099 Retail UPCs: 070074677545 070074680170 070074681009
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0957-2022·2022-03-16

    Abbott Infant Formula Powder Recalled for Bacterial Contamination

    Abbott Laboratories is recalling infant formula powder due to potential contamination with Cronobacter sakazakii and Salmonella Newport. Consumer complaints related to these pathogens in infants have been reported.

    Product
    Abbott Infant Formula Powder 12.6oz. can. 6 cans per case. Item numbers: Clinical Retail UPCs: N/A - Clinical
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0929-2022·2022-03-16

    Abbott Similac EleCare infant formula recalled for pathogen contamination

    Abbott is recalling approximately 95,077 cases of Similac EleCare infant formula due to consumer complaints involving Cronobacter sakazakii and Salmonella Newport in infants, and detection of Cronobacter sakazakii in the manufacturing facility.

    Product
    Abbott Similac EleCare HMO, Abbott Similac EleCare, Abbott EleCare Similac Gold, Abbott EleCare Similac 400g can. 6 cans per case Item numbers: 6676006 6676012 6676021 6676025 6676030 6676045 6676053 6676057 Retail UPCs: 8699548995217 0070074124155 007007412385
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0925-2022·2022-03-16

    Abbott Similac infant formula recalled for pathogen contamination

    Abbott is recalling Similac infant formula due to possible contamination with Cronobacter sakazakii and Salmonella Newport. The recall covers approximately 103,025 cases distributed nationwide and worldwide.

    Product
    Abbott Similac Advance Step-2 22.5oz. plastic jar. 6 jars per case. Abbott Similac Advance 34oz. can. 6 cans per case. Abbott Similac Pro-Advance 20.6oz. and 859g. plastic jar. 6 jars per case. Item numbers: 6499113 6698313 6818113 6818313 Retail UPCs: 055325000808
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0953-2022·2022-03-16

    Abbott EleCare Jr Nutrition Powder Recalled Due to Bacterial Contamination

    Abbott is recalling EleCare Jr Amino Acid-Based Nutrition Powder due to consumer complaints of Cronobacter sakazakii and Salmonella Newport in infants. The bacteria was also found in the manufacturing facility.

    Product
    Abbott EleCare Jr Amino Acid-Based Nutrition Powder Chocolate 14.1oz. can. 6 cans per case. Item numbers: 66273 Retail UPCs: 070074662718
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0954-2022·2022-03-16

    Abbott Similac Alimentum Infant Formula Recalled for Pathogenic Bacterial Contamination

    Abbott is recalling Similac Alimentum infant formula due to consumer complaints involving Cronobacter sakazakii and Salmonella Newport bacteria. The bacteria were found in some products and in the manufacturing facility.

    Product
    Abbott Similac Alimentum 400g. can. 6 cans per case. Item numbers: 5705806 Retail UPCs: 8699548994869
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0918-2022·2022-03-16

    Abbott EleCare Infant Formula Batch 26811Z200 Recalled for Pathogen Contamination

    Abbott Laboratories is recalling Batch 26811Z200 of Abbott EleCare Infant Formula Unflavoured due to consumer complaints involving Cronobacter sakazakii and Salmonella Newport in infants.

    Product
    Abbott EleCare Infant Formula Unflavoured 400g can. 6 cans per case. Item number 5466539 Retail unit UPC 070074104591
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0933-2022·2022-03-16

    Abbott Similac Pro-Advance infant formula recalled for Cronobacter and Salmonella

    Abbott is recalling Similac Pro-Advance infant formula due to potential contamination with Cronobacter sakazakii and Salmonella Newport. Consumer complaints related to these pathogens in infants have been reported, and the bacteria was found in the manufacturing facility.

    Product
    Abbott Similac Pro-Advance 20.6oz., 30.3oz., 34oz., and 658g plastic jar. 6 jars per case. 7oz. can. 6 cans per case. Item numbers: 6720113 6720813 6726613 6818013 6818213 6832313 Retail UPCs: 055325002499 055325002543 055325002604 055325002819 055325002833 05
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0652-2022·2022-03-16

    Oxycodone Hydrochloride Oral Solution Recall Due to Impurity Failure

    American Health Packaging is recalling one lot of Oxycodone Hydrochloride Oral Solution due to impurity failure detected at initial testing of the repackaged product.

    Product
    OXYCODONE HYDROCHLORIDE — OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0926-2022·2022-03-16

    Abbott Similac Sensitive Infant Formula Recalled for Bacterial Contamination

    Abbott Similac Sensitive infant formula is being recalled due to consumer complaints of Cronobacter sakazakii and Salmonella Newport in infants, with evidence of bacterial contamination in the manufacturing facility.

    Product
    Abbott Similac Sensitive Lactose Sensitivity 22oz. plastic jar. 6 jars per case. Item numbers: 6499813 Retail UPCs: 055325001218
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0944-2022·2022-03-16

    Abbott Similac Organic infant formula recalled for pathogenic bacteria contamination

    Abbott is recalling Similac Organic infant formula due to potential Cronobacter sakazakii and Salmonella Newport contamination. The recall affects roughly 8514 cases distributed nationwide and internationally.

    Product
    Abbott Similac Organic with A2 Milk Toddler Drink 23.2oz plastic jar. 4 jars per case. Abbott Similac Organic Toddler with A2 Milk Infant Formula with Iron 20.6oz. plastic jar. 4 jars per case. Item numbers: 67905 68104 Retail UPCs: 070074677576 070074681054
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0947-2022·2022-03-16

    Abbott Similac 360 Infant Formula Recalled for Cronobacter and Salmonella Contamination

    Abbott Laboratories is recalling Similac 360 Total Care Sensitive Infant Formula due to potential Cronobacter sakazakii or Salmonella Newport contamination. The recall affects products distributed in the United States and worldwide.

    Product
    Abbott Similac 360 Total Care Sensitive Infant Formula with Iron 7oz. can. 6 cans per case. 20.1oz. and 29.5oz. plastic jar. 4 jars per case. Item numbers: 68070 68072 68118 Retail UPCs: 070074680712 070074680736 070074681191
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0938-2022·2022-03-16

    Abbott Similac Sensitive infant formula recall due to pathogen contamination

    Abbott is recalling Similac Sensitive infant formula due to potential contamination with Cronobacter sakazakii or Salmonella Newport. Consumer complaints related to these pathogens in infants and evidence of Cronobacter in the facility prompted the Class I recall.

    Product
    Abbott Similac Sensitive 34oz. plastic jar. 6 jars per case. Abbott Similac Sensitive Infant Formula with Iron 12.5oz. can and 20.1oz. plastic jar. 6 units per case. Item numbers: 68082 5753978 6748901 674891L Retail UPCs: 070074680835 070074575414 070074122380
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0716-2022·2022-03-16

    LuSys COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization

    Lusys Laboratories is recalling 14,745 kits of COVID-19 antigen test kits that lack FDA clearance, approval, or emergency use authorization. The kits were distributed nationwide and internationally without required regulatory validation.

    Product
    LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0955-2022·2022-03-16

    Abbott Similac Alimentum Infant Formula Recalled for Cronobacter and Salmonella Contamination

    Abbott Laboratories is recalling 45,223 cases of Similac Alimentum infant formula due to consumer complaints involving Cronobacter sakazakii and Salmonella Newport in infants, and evidence of Cronobacter sakazakii in the manufacturing facility.

    Product
    Abbott Similac Alimentum Allergies & Colic Hypoallergenic Infant Formula 400g. can. 6 cans per case. Item numbers: 5707713 Retail UPCs: 055325000624
    Category
    Food
    Distribution
    Distributed nationwide