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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1–25 of 58

  • CriticalFDA (Drugs)·D-0211-2025·2025-02-05

    Prograf Tacrolimus Capsules Recall: Empty Capsules in Bottles

    Astellas Pharma recalls Prograf (tacrolimus) 0.5 mg capsules distributed nationwide due to empty capsules in bottles. Affected lot 0E3353D expires March 31, 2026.

    Product
    PROGRAF — PROGRAF (TACROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0620-2024·2024-08-07

    Dietary Supplement Recalled for Undeclared Diclofenac and Omeprazole

    SoloVital's Umary Hyaluronic Acid supplement was recalled because FDA testing found it contains undeclared Diclofenac and Omeprazole. The product, marketed without approved NDA/ANDA, affected 1,331 bottles distributed nationwide.

    Product
    Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0554-2024·2024-06-19

    Docetaxel Injection Recalled Nationwide for Stopper Particulate Matter

    Sagent Pharmaceuticals is recalling Docetaxel Injection due to particulate matter from the vial stopper contaminating the drug. The recall affects 2,806 vials distributed nationwide.

    Product
    DOCETAXEL — DOCETAXEL (DOCETAXEL ANHYDROUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0508-2024·2024-05-29

    Phenylephrine Injection Recalled Due to Ephedrine Label Mix-Up

    Hikma Injectables USA Inc is recalling phenylephrine injection syringes that were mislabeled as containing ephedrine. The mix-up creates a serious risk of administering the wrong medication to patients.

    Product
    Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
    Category
    Drug
    Distribution
    5 states
  • CriticalFDA (Drugs)·D-0459-2024·2024-05-01

    FDA Recalls Alcoholada Gel Pain Reliever Over Methanol Contamination

    Alcoholada Gel pain reliever is being recalled because the ethanol ingredient contains methanol contamination. The FDA classified this as a Class I recall affecting 9,625 bottles distributed nationwide.

    Product
    Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1 , Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbe
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0298-2024·2024-02-14

    Drug: CVS Health Lubricant Gel Drops recalled nationwide for non-sterility

    CVS Health Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) are being recalled nationwide due to non-sterility concerns. All lots of the product in single and twin pack bottles are affected.

    Product
    CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-704-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-704-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0303-2024·2024-02-14

    FDA recalls non-sterile EQUATE lubricant eye drops nationwide

    Walmart's EQUATE brand Hydration PF Lubricant Eye Drops are being recalled due to non-sterility. This FDA Class I recall affects 33,984 bottles distributed nationwide.

    Product
    EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10 mL) bottles, Distributed by: Walmart Inc., Bentonville, AR 72712, NDC 79903-168-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0305-2024·2024-02-14

    FDA Recalls CVS Health Lubricating Eye Drops Due to Non-Sterility

    CVS Health brand Lubricating Eye Drops are being recalled due to non-sterility. The FDA Class I recall affects 45,408 bottles distributed nationwide.

    Product
    CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-711-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0293-2024·2024-02-14

    FDA recalls Rugby brand lubricating eye drops nationwide for non-sterility

    Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops are being recalled nationwide due to non-sterility. The recall affects all lots of the 0.5 FL OZ bottles distributed.

    Product
    Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0308-2024·2024-02-14

    FDA Class I Drug Recall: Non-Sterile Multi-Action Relief Drops

    Rite Aid is recalling Multi-Action Relief Drops nationwide due to non-sterility concerns. The FDA classified this as a Class I recall affecting 9,216 bottles.

    Product
    Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-2254-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0299-2024·2024-02-14

    Drug recall: DRY EYE RELIEF eye drops for non-sterility

    FDA recalls DRY EYE RELIEF eye drops nationwide due to non-sterility. The ophthalmic product distributed in 23,208 bottles affects all lots. Consumers should discontinue use immediately.

    Product
    DRY EYE RELIEF — DRY EYE RELIEF (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0279-2024·2024-02-07

    Phenylephrine IV Bags Recalled for Double-Dose Filling System Malfunction

    Denver Solutions is recalling 29,016 Phenylephrine HCl IV bags distributed nationwide. A filling system malfunction can result in some bags receiving double doses of this potent injectable drug.

    Product
    PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0323-2024·2024-02-07

    FDA Recalls Zenzedi Dextroamphetamine Sulfate Due to Label Mix-up

    The FDA has recalled Zenzedi (Dextroamphetamine Sulfate) 30 mg tablets due to a labeling error. The recall affects 4,662 bottles distributed nationwide.

    Product
    ZENZEDI — ZENZEDI (DEXTROAMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0277-2024·2024-02-07

    Fentanyl Citrate IV Bags Recalled Due to Double-Dose Filling System Malfunction

    Denver Solutions recalled 8,976 IV bags of fentanyl citrate nationwide due to a malfunction in the semi-automated filling system that could deliver double the intended dose.

    Product
    FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0282-2024·2024-02-07

    FDA Recalls Vancomycin IV Bags Due to Dosing System Malfunction

    Denver Solutions is recalling 7,548 IV bags of vancomycin due to a manufacturing system malfunction that can deliver double doses. The product was distributed nationwide.

    Product
    VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0131-2024·2023-11-29

    Eye Drops Recalled for Non-Sterility Issues from Manufacturing Facility

    Cardinal Health is recalling LEADER brand Eye Irritation Relief drops due to non-sterility concerns. FDA testing found insanitary conditions and positive bacterial results at the manufacturing facility, affecting 11,629 units distributed nationwide.

    Product
    EYES IRRITATION RELIEF — EYES IRRITATION RELIEF (POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0132-2024·2023-11-29

    FDA Recalls Non-Sterile Dry Eye Relief Drops Due to Bacterial Contamination

    Cardinal Health is recalling all lots of LEADER brand Dry Eye Relief nationwide due to non-sterility. FDA found insanitary manufacturing conditions and positive bacterial test results.

    Product
    DRY EYE RELIEF — DRY EYE RELIEF (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0107-2024·2023-11-29

    Polyvinyl Alcohol Eye Drops Recalled for Non-Sterile Manufacturing Conditions

    FDA recalls Polyvinyl Alcohol 1.4% Lubricating Eye Drops nationwide due to non-sterile manufacturing conditions found during inspection.

    Product
    Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0037-2024·2023-10-11

    FDA Recalls Dr. Berne's MSM Drops Due to Non-Sterility Concerns

    Dr. Berne's MSM DROPS 5% Solution was recalled by the FDA for non-sterility issues. Lot 6786, with expiration date March 31, 2025, is distributed nationwide and internationally.

    Product
    Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], UPC 00854582001111.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0921-2023·2023-07-19

    Artificial Tears Eye Drops Recalled for Bacterial Contamination

    Delsam Pharma's Artificial Tears eye drops are being recalled nationwide due to bacterial contamination found in unopened bottles. Consumers should stop using affected products immediately.

    Product
    Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0938-2023·2023-07-19

    Prescription albuterol inhalers recalled nationwide due to defective valve seals

    Cipla USA is recalling 278,538 albuterol sulfate inhalers nationwide with specific lot numbers due to defective valve gaskets that cause empty inhalers or medication leakage. Check your lot number and contact your healthcare provider if affected.

    Product
    ALBUTEROL SULFATE — ALBUTEROL SULFATE (ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0455-2023·2023-03-15

    Hand Sanitizer Recalled for Methanol and Acetaldehyde Contamination

    Snowy Range Blue hand sanitizer is recalled due to FDA findings of methanol, acetaldehyde, and acetal above permissible limits. The product was distributed nationwide across all lot codes.

    Product
    Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distributed by Reliable Products, LLC, Cheyenne, WY 82003, NDC 75288-100-04.
    Category
    Drug
    Distribution
    Distributed nationwide