The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

2301–2325 of 18005

  • ModerateFDA (Drugs)·D-1091-2023·2023-08-30

    Helix Tri-Active Therapy Cream Recalled for Manufacturing Quality Deviations

    Parker Laboratories is voluntarily recalling Helix Tri-Active Therapy Cream due to manufacturing quality control deviations. The recall affects products with lot numbers A1221010 and A1221011, expiring December 9, 2023, distributed in the United States, Singapore, Korea, and Hong Kong.

    Product
    Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (NDC 30775-052-03) and b) 4 fl. oz. tube (NDC 30775-052-04) Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1084-2023·2023-08-23

    Toothpaste Label Mix-Up: Wrong Tube Labels in Strawberry Cartons

    Hello wild strawberry fluoride toothpaste cartons contain tubes incorrectly labeled as hello fresh watermelon fluoride free toothpaste. 182,046 units affected nationwide.

    Product
    hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v fluoride ion), NET WT 4.2 OZ (119 g), Distributed by Hello Products LLC, Montclair, NJ 07042, UPC 8 19156 02026 4 (carton), 12-count case GTIN: 20819156020268; strawberry tubes also sold in Strawberry 3-p
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1085-2023·2023-08-23

    PLUVICTO Injection Recalled for Incorrect Lot and Expiration Date Labels

    PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) injection vials were labeled with incorrect lot numbers and expiration dates. The manufacturer is recalling affected lots distributed nationwide.

    Product
    PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelerator Appllications USA, Inc., 57 E. Willow Street NJ 07041, Milburn, USA, NDC 69488-010-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1086-2023·2023-08-23

    Tobramycin Ophthalmic Solution recalled for failed quality specifications

    Alembic Pharmaceuticals is recalling 82,400 bottles of Tobramycin Ophthalmic Solution nationwide because the product failed to meet impurities and degradation specifications.

    Product
    TOBRAMYCIN OPHTHALMIC SOLUTION — TOBRAMYCIN OPHTHALMIC SOLUTION (TOBRAMYCIN OPHTHALMIC SOLUTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1082-2023·2023-08-16

    Dofetilide Capsules Recalled Due to Out-of-Specification Content Uniformity

    Sun Pharmaceutical recalls Dofetilide 500 mcg capsules nationwide due to out-of-specification results in content uniformity testing. Affected lot DNE0217A with expiration 01/2025 may not meet pharmaceutical specifications.

    Product
    DOFETILIDE — DOFETILIDE (DOFETILIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1081-2023·2023-08-09

    Prescription Birth Control Tablets Recalled for Failed Stability Testing

    Lupin Pharmaceuticals is recalling TYDEMY birth control tablets due to failed stability testing. Consumers should contact their healthcare provider.

    Product
    TYDEMY — TYDEMY (DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0996-2023·2023-08-09

    Neonatal TPN solution recalled for lack of sterility assurance

    Central Admixture Pharmacy Services is recalling 296 bags of neonatal TPN starter solution due to lacking validation data for decontamination cycles, raising concerns about sterility assurance.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0418-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1041-2023·2023-08-09

    FDA Recalls Cardioplegia Solution for Lacking Sterility Validation Data

    Central Admixture Pharmacy Services is recalling a cardioplegia solution used during heart surgery due to insufficient validation data for sterilization cycles. The 104-bag recall covers products distributed nationwide.

    Product
    CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-0215-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0985-2023·2023-08-09

    Neonatal TPN Starter Bags Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services recalls 128 neonatal TPN starter bags distributed nationwide due to lacking validation of decontamination procedures, creating inability to assure product sterility.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0400-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1020-2023·2023-08-09

    Cardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling a cardioplegia solution nationwide due to lack of sterility assurance and insufficient validation data for sterilization decontamination cycles.

    Product
    CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium/low tromethamine, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0009-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0953-2023·2023-08-09

    IV Medication Recall: dilTIAZem Bags Lack Sterility Assurance

    Central Admixture Pharmacy Services is recalling 3,699 bags of dilTIAZem IV medication due to lack of assurance of sterility and missing validation data for decontamination cycles. The affected medication was distributed nationwide.

    Product
    dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0950-2023·2023-08-09

    Vancomycin IV Bags Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 4,824 bags of vancomycin IV medication nationwide due to inadequate validation of sterilization processes. The manufacturer cannot confirm proper sterility.

    Product
    vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix AZ 85043, NDC: 72196-6073-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1064-2023·2023-08-09

    Morphine Syringes Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 1,699 morphine syringes nationwide due to lack of validated sanitization cycles, which may compromise sterility assurance.

    Product
    morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2040-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0954-2023·2023-08-09

    EPINEPHrine IV bags recalled nationwide due to lack of sterility assurance

    Central Admixture Pharmacy Services is recalling 9,121 epinephrine IV bags distributed nationwide due to lack of sterility assurance and insufficient validation data for decontamination cycles.

    Product
    EPINEPHrine 4mg/250mL added to 0.9% sodium chloride, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0951-2023·2023-08-09

    FDA recalls dilTIAZem IV bags due to sterility assurance concerns

    Central Admixture Pharmacy Services is recalling 2,260 dilTIAZem IV bags nationwide because validation data for the decontamination process is lacking. Affected lots expire between July and August 2023.

    Product
    dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0998-2023·2023-08-09

    Neonatal TPN Bags Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services recalls 420 bags of neonatal TPN containing amino acids and dextrose due to lack of assurance of sterility. Validation data for decontamination cycles was not available.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0428-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1038-2023·2023-08-09

    Cardioplegia Solution Recalled Due to Inadequate Sterility Assurance

    Central Admixture Pharmacy Services is recalling cardioplegia solution IV bags nationwide due to lack of validated sterilization processes. The recall affects 184 bags from two lots.

    Product
    CARDIOPLEGIA SOLUTION, low K, Maintenance 4:1 Plasmalyte/Tromethamine, Low Potassium, IV Bag, total volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0112-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1021-2023·2023-08-09

    Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency

    Central Admixture Pharmacy Services recalls Cardioplegia Solution (Lot 36-253947) due to lack of sterility assurance and insufficient decontamination validation. Healthcare facilities should discontinue use and contact the manufacturer.

    Product
    CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag, Total Volume = 572.64 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1023-2023·2023-08-09

    Cardioplegia Solution recalled for lack of sterility assurance

    Central Admixture Pharmacy Services is recalling 56 bags of Cardioplegia Solution due to lack of sterility assurance and missing validation data for decontamination cycles. Product was distributed nationwide.

    Product
    CARDIOPLEGIA SOLUTION, 7.5 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 238.75 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0007-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0957-2023·2023-08-09

    Epinephrine IV Bags Recalled Due to Unvalidated Sterility Process

    Central Admixture Pharmacy Services is recalling 333 units of epinephrine 2 mg in dextrose 5% IV bags because validation data for sterilization procedures is lacking, raising concerns about product sterility assurance.

    Product
    EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0948-2023·2023-08-09

    Vancomycin IV Bags Recalled Nationwide for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 3,980 IV vancomycin bags nationwide. The decontamination process was not properly validated, raising sterility concerns. No illnesses reported.

    Product
    vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6064-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1016-2023·2023-08-09

    FDA Recalls Cardioplegia Solution for Lack of Sterility Assurance

    The FDA has recalled Central Admixture Pharmacy Services' Cardioplegia Solution 40 mEq K due to insufficient validation data for sterilization processes. The 80-bag lot may not meet sterility standards required for cardiac use.

    Product
    CARDIOPLEGIA SOLUTION 40 mEq K, Warm Induction 4:1 High Potassium, IV Bag, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0002-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0981-2023·2023-08-09

    Heparin intravenous bags recalled due to sterility assurance failure

    Central Admixture Pharmacy Services is recalling 448 bags of heparin 7500 units in 0.9% sodium chloride IV solution due to lack of assurance of sterility. Validation data for decontamination cycles was not established.

    Product
    heparin 7500 units added to 0.9% sodium chloride 1000mL, CONCENTRATION = 7.5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7009-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1071-2023·2023-08-09

    Ketamine Injection Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 2,994 syringes of ketamine injection distributed nationwide due to lack of validated sterilization procedures that ensure product sterility.

    Product
    ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1
    Category
    Drug
    Distribution
    Distributed nationwide