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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5601–5625 of 11856

  • SevereFDA (Drugs)·D-0431-2019·2019-02-20

    Promise Pharmacy Recalls Acetylcysteine Ophthalmic Solution Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 75 bottles of Acetylcysteine Ophthalmic Solution because the product lacks sterility assurance. The recall covers nationwide distribution in the USA.

    Product
    Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0463-2019·2019-02-20

    Promise Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 266 vials of Sermorelin 15mg injections because they lack sterility assurance. The products were distributed nationwide.

    Product
    Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0457-2019·2019-02-20

    Promise Pharmacy Recalls Epithalon Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling Epithalon 15mg injections due to a lack of sterility assurance. The affected lots were distributed nationwide.

    Product
    Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0446-2019·2019-02-20

    Promise Pharmacy Recalls Ascorbic Acid Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 196 vials of Ascorbic Acid Injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0444-2019·2019-02-20

    Promise Pharmacy Recalls Amino Blend Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 158 vials of Amino Blend Injection because the product lacks sterility assurance. The recall covers lots distributed nationwide.

    Product
    Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0439-2019·2019-02-20

    Promise Pharmacy Recalls Multi Trace Injection Due to Sterility Concerns

    Promise Pharmacy is recalling Multi Trace injection vials because they may lack sterility assurance. The recall covers 30 mL vials distributed nationwide.

    Product
    Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0468-2019·2019-02-20

    Promise Pharmacy Recalls Nicotinamide Adenine Dinucleotide Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling specific lots of Nicotinamide Adenine Dinucleotide injections due to a lack of sterility assurance. The affected products were distributed nationwide in the USA.

    Product
    Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0445-2019·2019-02-20

    Promise Pharmacy Recalls Glutathione Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling specific lots of Glutathione Injection because of a lack of sterility assurance. The affected products were distributed nationwide.

    Product
    Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0447-2019·2019-02-20

    Promise Pharmacy Recalls Thymosin Beta-4 Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 94 vials of Thymosin Beta-4, 15 mg Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0481-2019·2019-02-20

    Promise Pharmacy Recalls Folic Acid Injection Due to Sterility Concerns

    Promise Pharmacy is recalling Folic Acid 5mg/ml injections because the product lacks sterility assurance. The recall covers nationwide distribution.

    Product
    Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0453-2019·2019-02-20

    Promise Pharmacy Recalls Ipamorelin Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 416 vials of Ipamorelin 9 mg injection because the product lacks sterility assurance. The affected lots were distributed nationwide.

    Product
    Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0473-2019·2019-02-20

    Promise Pharmacy Recalls Trim Calm Vials Due to Sterility Concerns

    Promise Pharmacy is recalling 7 vials of Trim Calm due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Trim Calm, GABA/Magnesium/Taurine/Theanine, 50mg/50mg/50mg/50mg/ml, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0451-2019·2019-02-20

    Promise Pharmacy Recalls Sermorelin Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 296 vials of Sermorelin/GHRP2/GHRP6 injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0460-2019·2019-02-20

    Promise Pharmacy Recalls HCG Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 654 vials of HCG injections nationwide due to a lack of sterility assurance.

    Product
    HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0471-2019·2019-02-20

    Promise Pharmacy Recalls Zinc Sulfate Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling specific lots of Zinc Sulfate injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0478-2019·2019-02-20

    Promise Pharmacy Recalls Dexpanthenol Injection Vials Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 7 vials of Dexpanthenol Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0437-2019·2019-02-20

    Promise Pharmacy Recalls Prednisolone and Bromfenac Ophthalmic Solution for Sterility Concerns

    Promise Pharmacy is recalling 167 bottles of compounded Prednisolone and Bromfenac Ophthalmic Solution due to a lack of sterility assurance.

    Product
    Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0472-2019·2019-02-20

    Promise Pharmacy Recalls Folic Acid Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling Folic Acid Injection, 10 mg/mL, 10mL vials due to a lack of sterility assurance. The affected lots were distributed nationwide.

    Product
    Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0469-2019·2019-02-20

    Promise Pharmacy Recalls Niacinamide Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling Niacinamide injection, 100mg/mL, 5mL vials due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0434-2019·2019-02-20

    Promise Pharmacy Recalls Prednisolone and Gatifloxacin Ophthalmic Solution for Sterility Concerns

    Promise Pharmacy is recalling compounded Prednisolone and Gatifloxacin ophthalmic solution due to a lack of sterility assurance.

    Product
    Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo Drops: 3 mL Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0461-2019·2019-02-20

    Promise Pharmacy Recalls HCG Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 2,595 vials of HCG injections nationwide due to a lack of sterility assurance.

    Product
    HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0493-2019·2019-02-20

    Tris Pharma Recalls Infants' Ibuprofen Due to Higher Concentration

    Tris Pharma is recalling specific lots of Infants' Ibuprofen because the medication may contain a higher concentration of ibuprofen than labeled.

    Product
    Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3, NDC 59779-925-23.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0433-2019·2019-02-20

    Promise Pharmacy Recalls Prednisolone and Gatifloxacin Eye Drops for Sterility Concerns

    Promise Pharmacy is recalling 55 bottles of compounded Prednisolone and Gatifloxacin Ophthalmic Solution due to a lack of sterility assurance.

    Product
    Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0495-2019·2019-02-20

    Tris Pharma Recalls Superpotent Infants' Ibuprofen Suspension

    Tris Pharma is recalling 35,280 bottles of Infants' Ibuprofen due to potential higher-than-labeled ibuprofen concentrations.

    Product
    Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39961 3, NDC 50428-1252-4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0443-2019·2019-02-20

    Promise Pharmacy Recalls Methylcobalamin Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 704 vials of Methylcobalamin 10,000 mcg Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide