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 the agency’s own highest classification or reported deaths or serious injuries, 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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12301–12325 of 17987

  • LowFDA (Drugs)·D-0818-2016·2016-04-20

    Fresenius Kabi Recalls Haloperidol Decanoate Injection Due to Impurity

    Fresenius Kabi USA, LLC is recalling Haloperidol Decanoate Injection due to an impurity out-of-specification result. The recall affects 48,210 units distributed nationwide and in Puerto Rico.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0823-2016·2016-04-20

    Amerisource Recalls Fenofibrate Capsules Due to Incorrect or Missing Labeling

    Amerisource Health Services is recalling 5,034 cartons of Fenofibrate Capsules (Micronized), 200 mg, due to incorrect or missing lot and expiration dates.

    Product
    Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 Carton of 30:NDC 68084-835-32, Individual Dose: NDC 68084-835-33.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0821-2016·2016-04-20

    Impax Recalls Fenofibrate Capsules Due to Incorrect or Missing Labeling

    Impax Laboratories is recalling 42,239 bottles of Fenofibrate Capsules (Micronized) 200 mg because some bottles have incorrect or missing lot and expiration dates.

    Product
    Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0803-2016·2016-04-13

    Meditech Formula 4 Injection Recalled for Sterility Assurance Issues

    Meditech Laboratories is recalling Formula 4 Injection vials due to incomplete data regarding production sterility.

    Product
    Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. .
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0808-2016·2016-04-13

    Meditech Formula 2 Vials Recalled Due to Expired Active Ingredient

    Meditech Laboratories is recalling Formula 2 vials because an active ingredient expired before the labeled Beyond Use Date.

    Product
    Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0816-2016·2016-04-13

    Actavis Recalls Amphetamine Tablets Due to Impurity Failures

    Actavis is recalling specific lots of amphetamine tablets because they failed impurity specifications. Consumers should stop using the product and contact their pharmacist.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0814-2016·2016-04-13

    Actavis Recalls Dextroamphetamine Tablets Due to Impurity Failures

    Actavis Elizabeth LLC is recalling 257,746 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, because they failed impurity specifications.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0804-2016·2016-04-13

    Meditech Formula 9 Injection Recalled for Sterility Assurance Issues

    Meditech Laboratories is recalling Formula 9 Injection vials due to incomplete production data regarding sterility assurance.

    Product
    Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0807-2016·2016-04-13

    Meditech Formula 0 Injection Recalled for Sterility Assurance Issues

    Meditech Laboratories is recalling Formula 0 Injection due to incomplete production data regarding sterility assurance.

    Product
    Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0802-2016·2016-04-13

    Meditech Formula 2 Injection Recalled for Superpotent Drug Ingredient

    Meditech Laboratories is recalling Formula 2 Injection vials because one ingredient exceeded assay specifications, making the drug superpotent.

    Product
    Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0810-2016·2016-04-13

    Purdue Pharma Recalls Intermezzo Tablets for Dissolution Failures

    Purdue Pharma is recalling Intermezzo (zolpidem tartrate) sublingual tablets because they failed to meet dissolution specifications.

    Product
    Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30.
    Category
    Drug
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0806-2016·2016-04-13

    Meditech Formula 3 Injection Recalled Due to Expired Active Ingredient

    Meditech Laboratories is recalling Formula 3 Injection vials because the active ingredient expired before the labeled Beyond Use Date.

    Product
    Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0805-2016·2016-04-13

    Meditech Formula 1 Injection Recalled Due to Expired Active Ingredient

    Meditech Laboratories is recalling 1,320 vials of Formula 1 Injection because the active ingredient expired before the labeled Beyond Use Date.

    Product
    Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0815-2016·2016-04-13

    Actavis Recalls Dextroamphetamine Tablets Due to Impurity Failures

    Actavis Elizabeth LLC is recalling 182,378 bottles of 30 mg Dextroamphetamine and Amphetamine tablets because they failed impurity specifications.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0813-2016·2016-04-13

    Actavis Recalls Dextroamphetamine Tablets for Impurity Failures

    Actavis is recalling specific lots of 10 mg dextroamphetamine tablets because they failed impurity specifications. The recall covers 114,388 bottles distributed nationwide.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0809-2016·2016-04-13

    Bio-pharm Recalls Ranitidine Syrup Due to Elevated Impurity Levels

    Bio-pharm, Inc. is recalling Ranitidine Syrup because routine stability testing detected elevated impurity levels.

    Product
    Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0801-2016·2016-04-13

    Virtus Pharmaceuticals Recalls Prenatal Supplement Due to Leaking Capsules

    Virtus Pharmaceuticals is recalling prenatal/postnatal folic acid supplements because the capsules may leak. The recall covers 688 bottles distributed nationwide.

    Product
    VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0811-2016·2016-04-13

    Apace KY LLC Recalls Minocycline Capsules Due to Mislabeled Lot Numbers

    Apace KY LLC is recalling 291 cartons of Minocycline Hydrochloride Capsules because individual blisters are mislabeled with an incorrect lot number.

    Product
    Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911) per carton (NDC 50268-569-13, barcode 5026856913), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0786-2016·2016-04-06

    Walter's Pharmacy Recalls Cefazolin Ophthalmic Solution Due to Sterility Concerns

    Walter's Pharmacy is recalling specific lots of Cefazolin 50 mg/mL Ophthalmic Solution because the sterility of the product cannot be assured.

    Product
    Cefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9999-69 / 89999-9001-04
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0795-2016·2016-04-06

    Walter's Pharmacy Recalls Edetate Disodium Eye Drops Due to Sterility Concerns

    Walter's Pharmacy is recalling specific lots of Edetate Disodium 2% Ophth Solution because the sterility of the product cannot be assured.

    Product
    Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0790-2016·2016-04-06

    Walter's Pharmacy Recalls Silver Nitrate Ophthalmic Solution Due to Sterility Concerns

    Walter's Pharmacy is recalling Silver Nitrate 1% Ophthalmic Solution due to a lack of assurance of sterility. The product is distributed in Pennsylvania.

    Product
    Silver Nitrate 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9991-92
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0794-2016·2016-04-06

    Walter's Pharmacy Recalls Acetylcysteine Eye Drops Due to Sterility Concerns

    Walter's Pharmacy is recalling two bottles of Acetylcysteine 10% Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed in Pennsylvania.

    Product
    Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9018-33
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0796-2016·2016-04-06

    Walter's Pharmacy Recalls Lidocaine Nebulizer Solution Due to Sterility Concerns

    Walter's Pharmacy is recalling Lidocaine Nebulizer 1% Solution because the product lacks assurance of sterility. The recall affects five bottles distributed in Pennsylvania.

    Product
    Lidocaine Nebulizer 1% Solution, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9020-61
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0791-2016·2016-04-06

    Walter's Pharmacy Recalls Tobramycin Ophthalmic Solution Due to Sterility Concerns

    Walter's Pharmacy is recalling Tobramycin 15mg/mL Ophthalmic Solution because the product lacks assurance of sterility. The recall affects specific lots distributed in Pennsylvania.

    Product
    Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9996-35
    Category
    Drug
    Distribution
    1 state