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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3176–3200 of 17762

  • HighFDA (Drugs)·D-0157-2023·2023-01-25

    Prescription Eye Drops Recalled for Manufacturing Control Deviations

    Akorn, Inc. is voluntarily recalling over 2 million bottles of Tobramycin Ophthalmic Solution due to Current Good Manufacturing Practice deviations affecting four product lots distributed nationwide.

    Product
    Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-290-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0132-2023·2023-01-25

    FDA Recalls Akorn AK-POLY-BAC Eye Ointment for CGMP Violations

    Akorn Inc. voluntarily recalls 36,025 tubes of AK-POLY-BAC Bacitracin/Polymixin B eye ointment nationwide due to manufacturing process deviations affecting product quality and sterility.

    Product
    AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35
    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-0156-2023·2023-01-25

    Eye-drop drug recall: Timolol solution due to manufacturing deviations

    Akorn is recalling over 1.3 million bottles of Timolol Maleate eye drops distributed nationwide due to manufacturing process violations. The voluntary recall addresses risks from Current Good Manufacturing Practice deviations.

    Product
    Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0165-2023·2023-01-25

    Prescription Rifampin Capsules Recalled Due to Failed Quality Specifications

    Amerisource Health Services is recalling Rifampin Capsules USP 300 mg nationwide due to failed impurities and degradation specifications. Affected patients should contact their healthcare provider before using remaining inventory.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0129-2023·2023-01-25

    Local anesthetic Sensorcaine vials recalled for subpotent epinephrine

    Fresenius Kabi is recalling Sensorcaine-MPF local anesthetic vials due to subpotent epinephrine levels. The affected batch (31,600 vials) was distributed nationwide.

    Product
    SENSORCAINE — SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0153-2023·2023-01-25

    Proparacaine Ophthalmic Solution Recalled for Manufacturing Quality Deviations

    Akorn is voluntarily recalling Proparacaine Ophthalmic Solution nationwide due to Current Good Manufacturing Practice deviations.

    Product
    Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12
    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-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
  • 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
  • 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-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-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-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-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-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-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-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-0155-2023·2023-01-25

    Sodium Chloride Ophthalmic Ointment Recalled for Manufacturing Deviations

    Akorn, Inc. has voluntarily recalled 524,506 tubes of Sodium Chloride Ophthalmic Ointment, USP 5%, nationwide due to Current Good Manufacturing Practice deviations.

    Product
    Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35
    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-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-0158-2023·2023-01-25

    FDA Recalls Tobramycin Ophthalmic Solution for Manufacturing Compliance Issues

    Akorn, Inc. is recalling 91,692 bottles of Tobramycin Ophthalmic Solution (0.3%) nationwide due to Current Good Manufacturing Practice deviations. The voluntary recall was initiated on October 13, 2022.

    Product
    Tobramycin 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 13985-604-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0163-2023·2023-01-25

    Hand Sanitizer Recalled for Manufacturing Practice Deviations

    Fisher Scientific voluntarily recalls HSANI500ML hand sanitizer (75% isopropyl alcohol) due to manufacturing practice deviations. The product was made under expired temporary FDA approval.

    Product
    Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.
    Category
    Drug
    Distribution
    Distributed nationwide