The Recall Desk

Severity 5 of 5

Critical recalls

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

What “critical” means here

Severity 5 (Critical) covers recalls where deaths or serious injuries have been reported, or where the agency itself classified the action as the highest severity (FDA Class I, NHTSA 'death/serious injury reported'). These are the recalls you should treat as urgent — stop using the product immediately and follow the agency's guidance. Common Severity-5 categories are pathogen-contaminated ready-to-eat foods (Listeria, E. coli O157, Salmonella), drug products with confirmed adverse-event reports, and vehicle defects with documented fatal crashes.

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.

1251–1275 of 7439

  • CriticalFDA (Drugs)·D-0663-2021·2021-07-28

    Shogun-X Capsules Recalled for Undeclared Prescription Drug Ingredients

    Shogun-X capsules have been recalled because they contain undeclared tadalafil, sildenafil, and/or vardenafil—prescription drugs not listed on the label. These are unapproved drugs whose safety and efficacy have not been established.

    Product
    Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0677-2021·2021-07-28

    Goose Creek Hand Sanitizer Recalled for Methanol and Chemical Contamination

    Goose Creek Hand Sanitizer aloe Dragonfruit Splash (3.38 FL. OZ.) is being recalled because the product is contaminated with methanol, benzene, and acetaldehyde. Consumers should stop using the product immediately.

    Product
    Goose Creek Hand Sanitizer aloe Dragonfruit Splash, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01332 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0686-2021·2021-07-28

    Thumbs Up 7 Black 25K Capsules Recalled for Undeclared Tadalafil

    Nuri Trading LLC is recalling Thumbs Up 7 Black 25K capsules nationwide because they contain undeclared tadalafil, an FDA-approved drug. The product was marketed without required approval, making it an unapproved drug with unestablished safety and efficacy.

    Product
    Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0685-2021·2021-07-28

    Shogun-X 7000 Capsules Recalled for Undeclared Prescription Drug Ingredients

    Nuri Trading LLC is recalling Shogun-X 7000 capsules nationwide because they contain undeclared tadalafil and sildenafil, FDA-approved prescription drugs not listed on the label, making the product an unapproved drug.

    Product
    Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0662-2021·2021-07-28

    Krazy Night Capsules Contain Undeclared Prescription Drug Ingredients

    Krazy Night capsules (1-count blister cards and 10-count boxes) are being recalled nationwide because they contain undeclared tadalafil, sildenafil, and/or vardenafil without FDA approval. These unapproved drugs have not undergone safety and efficacy review.

    Product
    Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0679-2021·2021-07-28

    Goose Creek Hand Sanitizer Recalled for Methanol and Benzene Contamination

    Scentsational Soaps & Candles Inc is recalling Goose Creek Hand Sanitizer aloe Melon Picnic spray (3.38 FL. OZ., Lot #20259) due to contamination with methanol, benzene, and acetaldehyde.

    Product
    Goose Creek Hand Sanitizer aloe Melon Picnic, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 14630 02424 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0642-2021·2021-07-07

    Ginseng Power 5000 Capsules Recalled for Undeclared Prescription Drug Ingredients

    NSNY Distributor Inc is recalling Ginseng Power 5000 capsules nationwide because they contain undeclared sildenafil and/or tadalafil, prescription medications not listed on the label or approved for sale in this product.

    Product
    Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010, UPC 0 40232 18144 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0641-2021·2021-07-07

    Premium OrgaZEN 7000 Capsules Recalled for Undeclared Sildenafil and Tadalafil

    Premium OrgaZEN 7000 capsules distributed nationwide have been recalled because they were marketed without FDA approval and contain undeclared sildenafil and/or tadalafil, prescription drugs that pose serious health risks.

    Product
    Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 32555 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·023-2021·2021-07-03

    Tyson Recalls Ready-to-Eat Chicken Products Due to Listeria Contamination

    Tyson Foods is recalling approximately 8.9 million pounds of ready-to-eat chicken products due to possible Listeria monocytogenes contamination linked to illnesses and one death.

    Product
    Tyson Foods Inc. Recalls Ready-To-Eat Chicken Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0634-2021·2021-06-30

    PremierZEN Platinum 8000 Capsules Recalled for Undeclared Drug Ingredients

    PremierZEN Platinum 8000 capsules, distributed nationwide, are being recalled because the product contains undeclared pharmaceutical ingredients (Sildenafil and Tadalafil) and was marketed without FDA approval.

    Product
    PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1786-2021·2021-06-16

    Medical Convenience Kits Recalled Due to Mold Contamination Risk

    Avid Medical is recalling 160 fistula care kits due to potential contamination from Aspergillus penicillioides fungal growth in a component applicator. The contamination could breach the kit's package integrity and affect other sterile components.

    Product
    FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0627-2021·2021-06-09

    Pfizer Lidocaine and Bupivacaine Injection Label Mix-Up Recall

    Pfizer has recalled 139,050 vials of injectable anesthetic medications due to a label mix-up: some vials labeled as Lidocaine contain Bupivacaine, and some labeled as Bupivacaine contain Lidocaine. Patients and healthcare providers should verify medication identity before use.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1651-2021·2021-06-09

    Alaris Infusion Pump Module Bezel Repair Parts Recalled for Separation Risk

    FDA recalls 22 serviced Alaris Model 8100 infusion pump units with bezel components that may crack or separate, risking free flow, over-infusion, under-infusion, or treatment interruption. Units distributed to Indiana and Texas between September 2020 and February 2021.

    Product
    Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
    Category
    Medical Device
    Distribution
    2 states
  • CriticalCPSC·21147·2021-06-03

    Fisher-Price Recalls Rock 'n Glide Soothers After Four Infant Deaths

    Fisher-Price is recalling 4-in-1 Rock 'n Glide Soothers and 2-in-1 Soothe 'n Play Gliders due to reports of four infant deaths from suffocation.

    Product
    Fisher-Price 4-in-1 Rock 'n Glide Soothers and 2-in-1 Soothe 'n Play Gliders
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0397-2021·2021-06-02

    Acella Recalls Subpotent NP Thyroid 15 Tablets Nationwide

    Acella Pharmaceuticals is recalling 154,726 bottles of NP Thyroid 15 tablets because they contain less active ingredient than labeled.

    Product
    NP THYROID 15 — NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0396-2021·2021-06-02

    Acella Recalls Subpotent NP Thyroid 15 Prescription Tablets

    Acella Pharmaceuticals is recalling NP Thyroid 15 tablets because they contain less active ingredient than labeled. The recall covers specific lots distributed nationwide.

    Product
    NP THYROID 15 — NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0395-2021·2021-06-02

    Acella Recalls Subpotent NP Thyroid 15 Tablets Nationwide

    Acella Pharmaceuticals is recalling NP Thyroid 15 tablets because they contain less active ingredient than labeled. The recall covers bottles distributed nationwide.

    Product
    NP THYROID 15 — NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0625-2021·2021-06-02

    Safeway Fresh Foods Recalls Robinson Fresh Turnip Greens Due to Listeria

    Safeway Fresh Foods is voluntarily recalling Robinson Fresh Turnip Greens because the product tested positive for Listeria monocytogenes.

    Product
    Robinson Fresh, Turnip Greens, 1lb. packages / Bags, 8 packages per case , Perishable/Keep Refrigerated . BEST IF USED BY 04/26/21 .
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0503-2021·2021-05-26

    Hi Tech Pharmaceuticals Recalls Isomorph 28 Whey Isolate for Undeclared Allergens

    Hi Tech Pharmaceuticals is recalling Isomorph 28 Pure Whey Isolate dietary supplements because FDA inspections found undeclared milk, wheat, and soy.

    Product
    ISOMORPH 28 PURE WHEY iSOLATE NEOPOLITAN ICE CREAM DIETARY SUPPLEMENT NET WT. 2lb, UPC 8 11836 02251 3 & 5lb, UPC 8 11836 02252 0 jugs Manufactured By: APS Distribution, Inc. 6015-B Unity Drive Norcross, GA 30071
    Category
    Food
    Distribution
    44 states
  • CriticalFDA (Food)·F-0539-2021·2021-05-26

    Natural Way Almond Butter Recalled for Potential Undeclared Peanuts

    Simkins Brothers Sweets is recalling Natural Way Almond Butter due to potential undeclared peanuts. Consumers should check for lot #505721.

    Product
    Natural Way Almond Butter 16 oz. UPC 850001775175 packaged in clear plastic jars
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0373-2021·2021-05-19

    Chloraprep One-Step Applicator Recalled for Loose Endcap Releasing Glass Shards

    CareFusion 213, LLC is recalling Chloraprep One-Step applicators because the endcap may fall off during activation, releasing glass shards into the solution.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0792-2021·2021-05-19

    Nature's Sunshine Recalls Vegan Protein Meal Replacement for Potential Milk Traces

    Nature's Sunshine Products is recalling specific lots of Love & Peas Protein Rich Meal Replacement because an ingredient may contain traces of milk, posing a risk to consumers avoiding dairy.

    Product
    Love & Peas Protein Rich Meal Replacement, Sugar Free, 1 LB 9 OZ (713 G) bag, Nature's Sunshine Products, Inc., Spanish Fork, Utah, 84660 (800) 223-8225, naturessunshine.com, UPC 0 99904 03087 9
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0487-2021·2021-05-19

    T. Marzetti Blanched Penne Rigati Recalled for Undeclared Egg Allergen

    T. Marzetti is recalling Blanched Penne Rigati because it contains an undeclared egg allergen. The product was distributed to a single consignee in California.

    Product
    Blanched Penne Rigati 8oz plastic bag 40 bags per case
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0581-2021·2021-05-12

    Velvet Cookie Dough Extreme Ice Cream Recalled for Listeria Risk

    Velvet Ice Cream Company is recalling Cookie Dough Extreme ice cream products due to potential Listeria monocytogenes contamination.

    Product
    Velvet Cookie Dough Extreme 3 Gallon Tub - 1 Tub per Case 56oz Carton - 4 Cartons per Case
    Category
    Food
    Distribution
    9 states