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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3201–3225 of 17964

  • HighFDA (Drugs)·D-0128-2023·2023-01-25

    Prescription Anesthetic Drug Recalled for Subpotent Epinephrine Content

    Fresenius Kabi is recalling Sensorcaine anesthetic injections nationwide due to subpotent epinephrine content. Affected batches may not provide adequate anesthesia or hemostasis during procedures.

    Product
    SENSORCAINE — SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0127-2023·2023-01-25

    Injectable Anesthetic Sensorcaine Recalled for Subpotent Epinephrine

    Sensorcaine injectable anesthetic is being recalled because testing showed the epinephrine component is below the required potency level. No illnesses or injuries have been reported.

    Product
    SENSORCAINE — SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0166-2023·2023-01-25

    Hand Sanitizer Recalled for Chemical Impurities and Manufacturing Defects

    SIREtizer Hand Sanitizer is recalled for containing acetal and acetaldehyde above allowable limits and manufacturing defects, including one superpotent lot.

    Product
    SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0, and c) 16.9 oz (500 ml), UPC 8 60003 85880 6 bottles, Southwest Iowa Renewable Energy, 10868 189th Street, Council Bluffs, IA 51503; Bottled by Southwest 6th Be
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0159-2023·2023-01-25

    Rasagiline Tablets Recalled for Foreign Particle Contamination

    Ascend Laboratories is recalling Rasagiline Mesylate Tablets 1 mg due to black spots and metallic specks on tablets. The recall affects 12,192 bottles distributed to customers in 19 states and Puerto Rico.

    Product
    RASAGILINE — RASAGILINE (RASAGILINE)
    Category
    Drug
    Distribution
    20 states
  • HighFDA (Drugs)·D-0141-2023·2023-01-25

    Ketorolac Tromethamine ophthalmic solution recalled due to manufacturing deviations

    Akorn is recalling Ketorolac Tromethamine Ophthalmic Solution nationwide due to manufacturing practice deviations. The voluntary recall affects multiple lot numbers of the 0.5% formulation.

    Product
    Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0160-2023·2023-01-25

    Triamterene and Hydrochlorothiazide Capsules Recalled for Failed Quality Specifications

    Lannett Company is recalling Triamterene and Hydrochlorothiazide Capsules nationwide because certain lots failed impurity and degradation quality specifications. Consumers taking affected lots should consult their pharmacist or physician.

    Product
    Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-1632-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0142-2023·2023-01-25

    Akorn recalls Levofloxacin eye drops due to manufacturing compliance issues

    Akorn, Inc. is recalling Levofloxacin Ophthalmic Solution due to manufacturing process deviations. The voluntary recall affects 3,108 bottles distributed nationwide.

    Product
    Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0140-2023·2023-01-25

    FDA recalls GONAK ophthalmic drug solution for manufacturing deviations

    Akorn voluntarily recalled 196,254 bottles of GONAK ophthalmic solution nationwide due to CGMP manufacturing practice deviations. This professional-use eye solution is employed in gonioscopic examinations.

    Product
    GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations, Mfd. by: Akorn, INc., Lake Forest, IL 60045. NDC: 17478-064-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0167-2023·2023-01-25

    SINUVA Sinus Implant Recalled for Failed Drug Release Specification

    Intersect ENT, Inc. is recalling 9,898 pouches of SINUVA sinus implants nationwide after detecting failed drug release specifications during stability testing. The implant may not deliver the medication as intended.

    Product
    SINUVA — SINUVA (MOMETASONE FUROATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0152-2023·2023-01-25

    FDA Recalls Akorn PAREMYD Eye Medication for Manufacturing Quality Deviations

    Akorn, Inc. is voluntarily recalling 51,601 bottles of PAREMYD eye medication nationwide due to manufacturing process deviations. The firm initiated the recall in October 2022.

    Product
    PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-704-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0134-2023·2023-01-25

    Akorn Artificial Tears Eye Drops Recalled for Manufacturing Quality Deviations

    Akorn, Inc. is voluntarily recalling 967,075 bottles of Artificial Tears Solution eye drops nationwide due to manufacturing process deviations identified during quality inspections.

    Product
    Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-060-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0162-2023·2023-01-25

    Levofloxacin Tablets Recalled for Embossing and Packaging Insert Mismatch

    Macleods Pharma USA recalls Levofloxacin Tablets 500 mg due to mismatched embossing on tablets versus the package insert labeling. The distributed bottles do not match the documented tablet markings.

    Product
    Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-022-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0136-2023·2023-01-25

    Ciprofloxacin ophthalmic solution recalled for manufacturing practice deviations

    Akorn, Inc. is recalling 1,584 bottles of Ciprofloxacin Ophthalmic Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary recall.

    Product
    Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-714-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0138-2023·2023-01-25

    Drug Recall: Erythromycin Ophthalmic Ointment Due to Manufacturing Deviations

    Akorn, Inc. recalls 1.1 million tubes of Erythromycin Ophthalmic Ointment nationwide due to manufacturing deviations. The voluntary, Class II recall was initiated by the firm.

    Product
    ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0150-2023·2023-01-25

    Antihistamine eye drops recalled due to manufacturing process deviations

    Akorn, Inc. is recalling 163,996 bottles of Olopatadine HCl Ophthalmic Solution 0.1% due to manufacturing process deviations. Affected lot numbers expire from October through December 2023.

    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0149-2023·2023-01-25

    Olopatadine HCl ophthalmic solution recalled for manufacturing deviations

    Olopatadine HCl Ophthalmic Solution 0.2% manufactured by Akorn, Inc. is being recalled nationwide due to Current Good Manufacturing Practice (CGMP) deviations affecting 173,928 bottles.

    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0148-2023·2023-01-25

    Ophthalmic solution recalled due to manufacturing quality control deviations

    Akorn, Inc. is recalling 1,752 bottles of Olopatadine HCL Ophthalmic Solution, USP 0.1% nationwide due to manufacturing quality control deviations. Lot 1L03A with expiration 10/31/2023 is affected.

    Product
    Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0146-2023·2023-01-25

    Ofloxacin Ophthalmic Solution Recalled Nationwide for Manufacturing Quality Issues

    Akorn, Inc. is recalling Ofloxacin Ophthalmic Solution 0.3% due to manufacturing quality deviations. The recall affects 65,006 bottles distributed nationwide.

    Product
    Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC: 13985-602-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0154-2023·2023-01-25

    Drug recall: Proparacaine eye solution due to manufacturing deviations

    Akorn, Inc. is recalling Proparacaine Hydrochloride Ophthalmic Solution due to manufacturing process deviations. The voluntary recall affects 23,026 bottles distributed nationwide.

    Product
    Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Distributed By: MWI Boise, ID 83705, NDC: 13985-611-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0137-2023·2023-01-25

    FDA Recalls Cromolyn Sodium Eye Drops Nationwide for Manufacturing Defects

    Akorn, Inc. is recalling 188,550 bottles of Cromolyn Sodium Ophthalmic Solution nationwide due to manufacturing quality control deviations.

    Product
    Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0164-2023·2023-01-25

    Hand Sanitizer Recalled Due to Manufacturing Practice Deviations

    Fisher Scientific voluntarily recalls hand sanitizer due to manufacturing deviations. The recall affects products distributed after March 31, 2022.

    Product
    Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0161-2023·2023-01-25

    Triamterene and Hydrochlorothiazide Capsules Recalled for Failed Quality Specifications

    Lannett Company is recalling Triamterene and Hydrochlorothiazide Capsules nationwide because the medication failed quality testing for impurity and degradation specifications. The recall affects 20,040 bottles.

    Product
    Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 100 Count bottle: 0527-1632-01; NDC 1,000 bottle: 0527-1632-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0151-2023·2023-01-25

    Prescription eye drop recall due to manufacturing compliance issues

    Akorn, Inc. is recalling Olopatadine HCl Ophthalmic Solution due to manufacturing process deviations. The nationwide voluntary recall involves 121,176 bottles distributed across the United States.

    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0145-2023·2023-01-25

    FDA recalls Akorn ophthalmic ointment for manufacturing process deviations

    Akorn, Inc. is recalling 2,082 tubes of Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment nationwide due to manufacturing process deviations. The recall is voluntary and initiated by the manufacturer.

    Product
    Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn, INC., Lake Forest, IL 60045. NDC: 17478-235-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0144-2023·2023-01-25

    Akorn Recalls Moxifloxacin Ophthalmic Solution for CGMP Deviations

    Akorn, Inc. is recalling 2,563 bottles of Moxifloxacin Ophthalmic Solution nationwide due to manufacturing deviations. The recall is voluntary and affects lot 1E28A with expiration date 4/30/2023.

    Product
    Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19
    Category
    Drug
    Distribution
    Distributed nationwide