The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. 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.

12851–12875 of 29186

  • 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-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 (Food)·F-0927-2019·2019-02-20

    Oskri Cashew Butter Recalled for Potential Listeria Contamination

    Oskri Corp. is recalling specific lots of cashew butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Cashew Butter, packaged under the following brands and sizes: - Wholesome Pantry Organic Cashew Butter UPC 04119006006. - Oskri Branded 16 oz. plastic jars UPC 66016-31647. Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551.
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Drugs)·D-0480-2019·2019-02-20

    Promise Pharmacy Recalls Zinc Sulfate Injection Due to Sterility Concerns

    Promise Pharmacy is recalling three vials of Zinc Sulfate injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Zinc Sulfate,10mg/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-0474-2019·2019-02-20

    Promise Pharmacy Recalls Procaine HCl Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 11 vials of Procaine HCl 2% injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Procaine HCl, 2% 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-0459-2019·2019-02-20

    Promise Pharmacy Recalls BPC 157 Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 37 vials of BPC 157 injections because they lack sterility assurance. The affected lot was distributed nationwide.

    Product
    BPC 157, 10mg injection, 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-0450-2019·2019-02-20

    Promise Pharmacy Recalls Sermorelin Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 341 vials of Sermorelin/GHRP2/GHRP6 injection because the product lacks sterility assurance. The recall covers lots distributed nationwide in the USA.

    Product
    Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/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-0440-2019·2019-02-20

    Promise Pharmacy Recalls Vitamin D3 Injections Due to Sterility Concerns

    Promise Pharmacy is recalling specific lots of Vitamin D3 50,000iu/mL injections nationwide due to a lack of sterility assurance.

    Product
    Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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-0477-2019·2019-02-20

    Promise Pharmacy Recalls Lysine HCl Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 11 vials of Lysine HCl injection due to a lack of sterility assurance. The affected lot was distributed nationwide.

    Product
    Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0467-2019·2019-02-20

    Promise Pharmacy Recalls MIC B12 Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling MIC B12+L-Carnitine+Chromium injections due to a lack of sterility assurance. The recall covers 64 vials distributed nationwide.

    Product
    MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium, 25mg/50mg/50mg/1mg/100mg/0.4mcg/ml, 10mL, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0454-2019·2019-02-20

    Promise Pharmacy Recalls Ipamorelin and Sermorelin Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 139 vials of Ipamorelin and Sermorelin injections nationwide due to a lack of sterility assurance.

    Product
    Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    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
  • SevereFDA (Food)·F-0922-2019·2019-02-20

    Oskri Organic Peanut Butter Recalled for Potential Listeria Contamination

    Oskri Corp. is recalling Organic Peanut Spicy Cayenne Butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Organic Peanut Spicy Cayenne Butter, packaged in 16 oz. Plastic jars UPC 66016-40111, pouches UPC 66016-40164. Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551.
    Category
    Food
    Distribution
    21 states
  • 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-0470-2019·2019-02-20

    Promise Pharmacy Recalls Myer's Cocktail Vials Due to Sterility Concerns

    Promise Pharmacy is recalling 5 vials of Myer's Cocktail due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6/Vit B1/Leucine/Vit B5/Riboflavin/Ascorbic Acid/Hydroxycobalamin/Magnesium Chloride, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0464-2019·2019-02-20

    Promise Pharmacy Recalls IGF-1-LR3 Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 59 vials of IGF-1-LR3, 3 mg injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    IGF-1-LR3, 3 mg injection, 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-0485-2019·2019-02-20

    Dr. Reddy's Recalls Levetiracetam Injection Due to Labeling Error

    Dr. Reddy's Laboratories is recalling Levetiracetam Injection bags because the primary label incorrectly identifies the product strength and sodium chloride concentration.

    Product
    LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM INJECTION)
    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-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-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