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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8776–8800 of 18015

  • ModerateFDA (Drugs)·D-0513-2019·2019-02-27

    Lupin Recalls Lovastatin Tablets Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling Lovastatin 40 mg tablets because the drug substance used was out of specification for impurity results.

    Product
    LOVASTATIN — LOVASTATIN (LOVASTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0514-2019·2019-02-27

    Mometasone Furoate Cream Recalled for NDC Typographical Error

    ACP Nimble Buyer, Inc. is recalling Mometasone Furoate Cream due to a typographical error in the National Drug Code (NDC) on the label.

    Product
    Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0506-2019·2019-02-27

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules 180mg because routine stability testing found high out-of-specification impurities.

    Product
    Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0497-2019·2019-02-27

    Advanced Pharma Recalls Oxytocin Injectable Solution Due to Superpotent Drug Concerns

    Advanced Pharma Inc. is recalling 12 bags of Oxytocin 10 Units Injectable Solution because the product may contain higher concentrations than labeled.

    Product
    Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0512-2019·2019-02-27

    Perrigo Recalls Ciclopirox Shampoo Due to Stability Testing Failures

    Perrigo New York, Inc. is recalling specific lots of Ciclopirox shampoo 1% because stability testing revealed out-of-specification related substances.

    Product
    CICLOPIROX — CICLOPIROX (CICLOPIROX)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0516-2019·2019-02-27

    Amerigen Recalls Temozolomide Capsules Due to Dissolution Failures

    Amerigen Pharmaceuticals is recalling Temozolomide Capsules, 5 mg, because the product failed to meet dissolution specifications.

    Product
    Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0476-2019·2019-02-20

    Promise Pharmacy Recalls Leucine/Isoleucine/Valine Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling Leucine/Isoleucine/Valine injection vials due to a lack of sterility assurance. The affected products were distributed nationwide.

    Product
    Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/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-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-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-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-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-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-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-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-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-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-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-0449-2019·2019-02-20

    Promise Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 255 vials of Sermorelin 9 mg injection nationwide due to a lack of sterility assurance.

    Product
    Sermorelin 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-0442-2019·2019-02-20

    Promise Pharmacy Recalls Methylcobalamin Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 252 vials of Methylcobalamin Injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Methylcobalamin lyophilized 50,000 mcg 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-0466-2019·2019-02-20

    Promise Pharmacy Recalls ICB-Complex Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 846 vials of ICB-Complex injection nationwide due to a lack of sterility assurance.

    Product
    ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine: 25mg/25mg/5mg/2.5mg/25mg/5mg/5mg/0.1mg/1.5mg/25mg/25mg/10mg/ML, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 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-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-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-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