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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10626–10650 of 17785

  • ModerateFDA (Drugs)·D-0808-2017·2017-05-31

    Advanced Pharma Recalls Sufentanil Citrate Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all lots of Sufentanil Citrate because the product may contain latex, which is not currently disclosed on the label.

    Product
    Sufentanil Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0842-2017·2017-05-31

    Advanced Pharma Recalls Famotidine HCl Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all lots of Famotidine HCl because the product may contain latex but lacks proper labeling.

    Product
    Famotidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0826-2017·2017-05-31

    Advanced Pharma Recalls Ephedrine Sulfate Due to Latex Labeling Defect

    Advanced Pharma Inc. is recalling all lots of Ephedrine Sulfate because the product may contain latex but lacks proper labeling.

    Product
    Ephedrine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0859-2017·2017-05-31

    Qualitest Recalls Hydrocortisone Lotion for Excessive Potency

    Qualitest Pharmaceuticals is recalling 109,620 bottles of Hydrocortisone Lotion, USP, 2.5% because the product is superpotent, meaning it contains more active ingredient than specified.

    Product
    HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7785-52.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0858-2017·2017-05-31

    Strides Pharma Recalls Benzonatate Capsules for Stability Failure

    Strides Pharma Inc. is recalling Benzonatate capsules due to out-of-specification preservative levels. The FDA classified this as a Class III recall.

    Product
    BENZONATATE — BENZONATATE (BENZONATATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0857-2017·2017-05-31

    Sun Pharmaceutical Recalls Children's Cetirizine Tablets for Hardness Issues

    Sun Pharmaceutical Industries is recalling 13,200 bottles of Children's Cetirizine Hydrochloride Chewable Tablets due to out-of-specification tablet hardness.

    Product
    Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-343-83.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0747-2017·2017-05-24

    Key Pharmacy Recalls TRI MIX Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX 40/30/2 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.

    Product
    TRI MIX 40/30/2 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0770-2017·2017-05-24

    Key Pharmacy Recalls Methyl-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 25 vials of Methyl-B12 injection due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.

    Product
    METHYL-B12 *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0765-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Glutathione Inhalation Solution

    Key Pharmacy and Compounding Center is recalling sterile compounded glutathione inhalation solution due to lack of assurance of sterility.

    Product
    GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0764-2017·2017-05-24

    Key Pharmacy Recalls Iron Special Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling Iron Special 5mL multiple-dose vials due to a lack of assurance of sterility.

    Product
    IRON SPECIAL 5ML MDV 60/10MG/5MCG/ML INJ, Injection, 60mg/1mg/5mcg/mL, Rx only, 5mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0779-2017·2017-05-24

    Key Pharmacy Recalls Sodium Carboxymethylcellulose Ophthalmic Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Sodium Carboxymethylcellulose 0.5% Ophthalmic Solution because the firm cannot ensure the product is sterile.

    Product
    SODIUM CARBOXYM-CELL PF 0.5% OPHTH, opthalmic, 0.50%, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0712-2017·2017-05-24

    Key Pharmacy Recalls Atropine Sulfate Ophthalmic Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling Atropine Sulfate 0.5% Ophthalmic Solution because the firm cannot assure the sterility of the product.

    Product
    ATROPINE SULFATE 0.5% OPHTH, Ophthalmic 0.50%, Rx only, 15mlLGlass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0743-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX 20/30/0.5 injection vials due to a lack of assurance of sterility.

    Product
    TRI MIX 20/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0760-2017·2017-05-24

    FDA Recalls Compounded Injection Due to Lack of Sterility Assurance

    Key Pharmacy and Compounding Center is recalling CHOL/IN/ME(L)/B6 10ML MDV injection due to lack of assurance of sterility.

    Product
    CHOL/IN/ME(L)/B6 10ML MDV 50/50/25/0.1MG/ML INJ, Injection, 50mg/50mg/25mg/0.1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0763-2017·2017-05-24

    Key Pharmacy Recalls Ferric Gluconate Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Ferric Gluconate Injection because the firm cannot guarantee the sterility of the compounded drug.

    Product
    FERR GLUC MDV 60MG/ML INJ, Injection, 60mg/mL, Rx only, Packaged in 5mL and 10mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0741-2017·2017-05-24

    Key Pharmacy Recalls TRI MIX Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX 16.7/4/0.27 5ML MDV MCG/MG/MG/ML INJ due to a lack of assurance of sterility.

    Product
    TRI MIX 16.7/4/0.27 5ML MDV MCG/MG/MG/ML INJ, Injection, 16.7mcg/4mg/0.27mg/ml, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0756-2017·2017-05-24

    Key Pharmacy Recalls PGE1/Procaine Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of PGE1/Procaine injections because the firm cannot guarantee the products are sterile.

    Product
    PGE1/PROCAINE 5ML MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0771-2017·2017-05-24

    Key Pharmacy Recalls Procaine HCL Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Procaine HCL 1% injections because the firm cannot assure the products are sterile.

    Product
    PROCAINE HCL 50ML MDV (CALIF) 1% INJ, Injection, 1%, Rx only, 50mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0769-2017·2017-05-24

    Key Pharmacy Recalls Methyl-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 26 vials of Methyl-B12 injection due to a lack of assurance of sterility.

    Product
    METHYL-B12 5ML MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0713-2017·2017-05-24

    Key Pharmacy Recalls CO-Q-10 Oil Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling CO-Q-10 Oil Injection due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.

    Product
    CO-Q-10 OIL 20ML MDV (CALIF) 25MG/ML INJ, Injection, 25mg/mL, Rx only, 20mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0758-2017·2017-05-24

    Key Pharmacy Recalls Alpha Lipoic Acid Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling Alpha Lipoic Acid injections due to a lack of assurance of sterility. The affected product was distributed in the U.S., Australia, and Canada.

    Product
    ALPHA LIPOIC ACID 25ML MDV 25MG/ML INJ, Injection, 25mg/mL, Rx only, 25 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0733-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded PGE1/CPZ Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ due to lack of assurance of sterility. The recall affects 2 vials distributed in the U.S., Australia, and Canada.

    Product
    PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ, Injection, 20mcg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0711-2017·2017-05-24

    Key Pharmacy Recalls Atropine Sulfate Ophthalmic Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Atropine Sulfate 0.01% Ophthalmic Solution because the firm cannot assure the sterility of the product.

    Product
    ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0768-2017·2017-05-24

    Key Pharmacy Recalls Magnesium Sulfate Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Magnesium Sulfate 50% injections because the firm cannot assure the sterility of the product.

    Product
    MAGNESIUM SO4 10ML MDV 50% INJ, Injection, 50%, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0718-2017·2017-05-24

    Key Pharmacy Recalls Folinic Acid Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Folinic Acid injections because the firm cannot guarantee the products are sterile.

    Product
    FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide