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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10726–10750 of 17785

  • ModerateFDA (Drugs)·D-0689-2017·2017-05-10

    Fluconazole Tablets Recalled for Failed Dissolution Specifications

    The Harvard Drug Group is recalling 914 cartons of Fluconazole 200 mg tablets because they failed to meet required dissolution specifications.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0688-2017·2017-05-10

    Harvard Drug Group Recalls Fluconazole Tablets for Failed Dissolution

    The Harvard Drug Group is recalling 2,341 cartons of Fluconazole 100 mg tablets because they failed to meet dissolution specifications.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0696-2017·2017-05-10

    Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failures

    Akorn Inc is recalling 55,968 bottles of Sulfamethoxazole and Trimethoprim Oral Suspension because the product failed to meet dissolution specifications.

    Product
    Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0694-2017·2017-05-10

    P & L Development Recalls Subpotent Diphenhydramine HCl Allergy Softgels

    P & L Development is recalling 369,012 cartons of diphenhydramine HCl allergy softgels sold under multiple brands due to low potency test results.

    Product
    Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24, UPC 0-36800-39134-5; (b) Rexall Since 1903 Aller
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0693-2017·2017-05-10

    Amneal Recalls Rabeprazole Sodium Tablets for Failed Dissolution Specifications

    Amneal Pharmaceuticals is recalling Rabeprazole Sodium Delayed Release Tablets, 20 mg, because the product failed to meet dissolution specifications.

    Product
    Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0692-2017·2017-05-10

    Aripiprazole Tablets Recalled for Out-of-Specification Assay Results

    The Harvard Drug Group is recalling Aripiprazole Tablets, 2 mg, due to out-of-specification assay results. The recall covers 36,990 tablets distributed nationwide and in Puerto Rico.

    Product
    Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0695-2017·2017-05-10

    Fagron Recalls Zinc Oxide Paste Due to Labeling Error

    Fagron, Inc. is recalling Zinc Oxide Paste 25% because of an incorrect strength value in the Drug Facts Panel.

    Product
    Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0681-2017·2017-05-03

    Isomeric Pharmacy Recalls Methylprednisolone Acetate Injection Vials for Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 4,001 vials of Methylprednisolone Acetate and Lidocaine HCl injection due to production processes that cannot assure sterility.

    Product
    Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1010, barcode 3 70285 10101 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0682-2017·2017-05-03

    Isomeric Pharmacy Recalls Methylprednisolone Acetate Injection Vials for Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 2,352 vials of Methylprednisolone Acetate and Lidocaine HCl injection due to production processes that cannot assure sterility.

    Product
    Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1011, barcode 3 70285 10111 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0683-2017·2017-05-03

    Isomeric Pharmacy Recalls Triamcinolone Acetonide Injection Vials for Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 2,335 vials of Triamcinolone Acetonide and Lidocaine HCl injection due to production processes that cannot assure sterility.

    Product
    Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1020, barcode 3 70285 10201 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0677-2017·2017-05-03

    FDA Recalls Unapproved hCG Body Shaper Product for Contamination

    The FDA is recalling hCG Body Shaper because it was marketed without approval and contains human chorionic gonadotropin, making it an unapproved drug.

    Product
    hCG Body Shaper, Highly Purified Human Chorionic Gonadotrophin 5000 IU, Colloidal Silver B12, Stabilizers/Excipients, Not For Medical Use, Must Be Refrigerated, Distributed by HCG Body Shaper, St. Peters, MO
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0687-2017·2017-05-03

    Isomeric Pharmacy Recalls Phenylephrine and Tropicamide Ophthalmic Drops

    Isomeric Pharmacy Solution, LLC is recalling 5,165 bottles of Phenylephrine 2.5% and Tropicamide 1% ophthalmic drops due to a lack of assurance of sterility.

    Product
    Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1300, barcode 3 70285 13001 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0686-2017·2017-05-03

    Isomeric Pharmacy Recalls Testosterone Injection Vials Due to Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 2,156 vials of Testosterone Cypionate and Propionate injection due to production processes that cannot assure sterility.

    Product
    Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1200, barcode 3 70285 12003 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0685-2017·2017-05-03

    Isomeric Pharmacy Recalls Injection Vials Due to Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 851 vials of a multi-dose injection product because production processes cannot assure sterility.

    Product
    Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0684-2017·2017-05-03

    Isomeric Pharmacy Recalls Triamcinolone Diacetate Vials Due to Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 1,951 vials of Triamcinolone Diacetate injection because production processes cannot assure sterility. The FDA has classified this as a Class II recall.

    Product
    Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0678-2017·2017-05-03

    Novartis Recalls Isopto Carpine Eye Drops for Impurity Failures

    Novartis Pharmaceuticals is recalling specific lots of Isopto Carpine eye drops due to failed impurities and degradation specifications.

    Product
    Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA NDC 0998-0206-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0680-2017·2017-05-03

    McKesson Recalls Donepezil HCl Tablets Due to Out-of-Specification Assay

    McKesson Packaging Services is recalling 476 cartons of Donepezil HCl 10mg tablets because routine stability testing revealed an out-of-specification assay result.

    Product
    Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container, Rx only, Manufactured by Sandoz, Inc., 506 Carnegie Center, Suite 400, Princeton, NJ 08805, Distributed by: McKesson Packaging Services, 7101 Weddington Rd, Concord, NC 28027, NDC
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0676-2017·2017-04-26

    Taro Recalls Nystatin and Triamcinolone Acetonide Cream for Stability Failures

    Taro Pharmaceuticals is recalling Nystatin and Triamcinolone Acetonide Cream because it failed content uniformity specifications during 18-month stability testing.

    Product
    NYSTATIN AND TRIAMCINOLONE ACETONIDE — NYSTATIN AND TRIAMCINOLONE ACETONIDE (NYSTATIN AND TRIAMCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0674-2017·2017-04-26

    InnovaGel Recalls Subpotent Diphenhydramine HCl Softgel Capsules

    InnovaGel is recalling approximately 7.9 million subpotent Diphenhydramine HCl 25 mg softgel capsules distributed in New York.

    Product
    Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0048P, NDC 6897080284
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0672-2017·2017-04-26

    Valeant Recalls CLENZIderm M.D. Pore Therapy Salicylic Acid Acne Treatment

    Valeant Pharmaceuticals is voluntarily recalling CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment due to discoloration.

    Product
    CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA. Product SKU 301876102042, NDC 0187-6102-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0673-2017·2017-04-26

    Valeant Recalls CLENZIderm M.D. Acne Treatment Kits Due to Discoloration

    Valeant Pharmaceuticals is voluntarily recalling 5,647 units of CLENZIderm M.D. Acne Treatment Systems nationwide due to product discoloration.

    Product
    CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotion (benzoyl peroxide 5% Acne Treatment) 47mL bottle, b) Daily Care Foaming Cleanser (Salicylic Acid 2% Acne Treatment) 118 mL bottle, c) Salicylic Acid 2% Acne Treatment 148mL, Valeant Pharmaceuticals No
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0675-2017·2017-04-26

    InnovaGel Recalls Subpotent Dye Free Allergy Softgel Gelatin Capsules

    InnovaGel is voluntarily recalling Dye Free Allergy Softgel Gelatin Capsules because they are subpotent. The affected product was distributed in New York.

    Product
    Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0067P, NDC 6897080284
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0657-2017·2017-04-19

    FDA Recalls Estrone Micronized Bulk Drug Due to Quality Assurance Failures

    The FDA is recalling Estrone Micronized bulk drug products manufactured by Qinhuangdao Zizhu Pharmaceutical due to cGMP deviations and lack of quality assurance.

    Product
    Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-003-04) (NDC 44132-003-02)(NDC 44132-003-06)
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0659-2017·2017-04-19

    FDA Recalls Ethinyl Estradiol Bulk Drug Due to Quality Assurance Failures

    The FDA is recalling bulk Ethinyl Estradiol Micronized manufactured by Qinhuangdao Zizhu Pharmaceutical due to cGMP deviations and lack of quality assurance.

    Product
    Ethinyl Estradiol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-002-05)
    Category
    Drug
    Distribution
    6 states