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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

2151–2175 of 11852

HighFDA (Drugs)·D-0224-2023·2023-02-01
FDA Recalls Mitomycin Ophthalmic Solution for Sterility Assurance Failure
Pharmacy Innovations is recalling Mitomycin ophthalmic solutions nationwide due to a lack of sterility assurance. An FDA inspection found insanitary conditions at the manufacturing facility.
Product
MITOMYCIN 0.4MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.4MG/ML (1ML VIAL) OPH SOLUTION; MITOMYCIN 0.4MG/ML (4ML VIAL) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0178-2023·2023-02-01
Sterile water injection vials recalled for trace product carryover risk
Nephron Pharmaceuticals recalls approximately 389,730 vials of sterile water for injection nationwide due to potential product carryover from manufacturing deviations. No illnesses have been reported.
Product
STERILE WATER — STERILE WATER (STERILE WATER)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0240-2023·2023-02-01
Antibiotic Eye Drops Recalled for Sterility Assurance Failure
Pharmacy Innovations is recalling Tobramycin Fortified 15mg/mL Ophthalmic Solution nationwide due to insanitary facility conditions that compromised sterility assurance. Consumers should discontinue use and contact their healthcare provider.
Product
TOBRAMYCIN FORTIFIED 15MG/ML OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0233-2023·2023-02-01
Pharmacy Innovations Progesterone Injectable Vial Recalled for Sterility Concerns
Pharmacy Innovations is recalling PROGESTERONE-GS OIL 100MG/ML injectable vials distributed nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.
Product
PROGESTERONE-GS OIL- 100MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0207-2023·2023-02-01
Injectable Ethyl Alcohol 95% Recalled Due to Sterility Assurance Concerns
Pharmacy Innovations is recalling Ethyl Alcohol 95% (5ML vial) Injectable nationwide because FDA inspection revealed insanitary conditions at the manufacturing facility that compromise sterility assurance.
Product
Ethyl Alcohol 95% (5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0235-2023·2023-02-01
FDA Recalls Scopolamine Ophthalmic Solution for Sterility Assurance Issues
Pharmacy Innovations recalled Scopolamine Hydrobromide 0.25% ophthalmic solution nationwide due to FDA inspection findings of insanitary facility conditions that compromise sterility assurance.
Product
SCOPOLAMINE HYDROBROMIDE 0.25% OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0230-2023·2023-02-01
Injectable Drug Recalled Due to Sterility Assurance Concerns
An injectable phosphatidylcholine/deoxycholic acid product manufactured by Pharmacy Innovations is being recalled nationwide due to lack of sterility assurance. FDA inspection revealed insanitary conditions at the manufacturing facility.
Product
PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID (10ML VIAL) 50MG/50MG/ML (5%/5%) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0200-2023·2023-02-01
Pharmacy Innovations Cyclosporine Eye Drops Recalled for Sterility Defect
Pharmacy Innovations is recalling Cyclosporine ophthalmic solutions (0.1%, 0.2%, 1%, 2%, and corn-oil-based 1%) due to lack of sterility assurance. FDA inspection found insanitary facility conditions.
Product
Cyclosporine (A) 0.1%; Cyclosporine (A) 0.2%; Cyclosporine (A) 1%; Cyclosporine (A) 2%; Cyclosporine (A) - Corn oil - 1% Oph solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0131-2023·2023-01-25
Daptomycin for Injection Recalled Due to Incorrect Labeling Dosage
Accord Healthcare is recalling Daptomycin for Injection labeled as 350 mg/vial but containing 500 mg/vial vials. The labeling error poses a dosing risk to patients.
Product
Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0133-2023·2023-01-25
Drug Recall: Artificial Tears Eye Ointment Due to Manufacturing Deviations
Akorn, Inc. is recalling Artificial Tears Ointment (1.16 million tubes nationwide) due to manufacturing practice deviations. The firm voluntarily initiated this recall.
Product
Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35
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-0147-2023·2023-01-25
Eye drop medication Olopatadine HCl recalled nationwide for manufacturing deviations
Akorn, Inc. is recalling 31,073 bottles of Olopatadine HCl ophthalmic solution nationwide due to current good manufacturing practice deviations. This voluntary recall was initiated by the manufacturer.
Product
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05
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-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-0135-2023·2023-01-25
Betaxolol ophthalmic solution recalled for manufacturing process violations
Akorn, Inc. is voluntarily recalling Betaxolol ophthalmic solution (6,273 bottles, lot 1A08A, exp. 12/31/2022) due to manufacturing deviations. Consumers should consult their healthcare provider.
Product
Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-705-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0139-2023·2023-01-25
FDA Recalls Nationwide Supply of Erythromycin Ophthalmic Ointment for Manufacturing Deviations
Akorn, Inc. is recalling 36,455 cartons of Erythromycin Ophthalmic Ointment USP 0.5% nationwide due to manufacturing process deviations. The company voluntarily initiated this Class II recall.
Product
Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31
Category
Drug
Distribution
Distributed nationwide
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-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-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-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-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-0103-2023·2023-01-18
QuadMix Plus Injectable Medication Recalled for Lack of Sterility Assurance
Northern VA Compounders is recalling QuadMix Plus injectable medication due to lack of assurance of sterility. The recall affects 78 vials distributed nationwide.
Product
QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
Category
Drug
Distribution
Distributed nationwide

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2151–2175 of 11852