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.
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.
Minimum severity
Akorn, Inc. recalled all lots of Gonak Hypromellose Ophthalmic Solution distributed in the USA and Puerto Rico after the firm ceased operations and could not complete required stability studies.
Akorn Inc. is recalling all lots of Pilocarpine Hydrochloride Ophthalmic Solution 2% due to manufacturing deviations that prevented completion of stability studies. The product was distributed nationwide in the USA and Puerto Rico.
FDA is recalling all lots of Calcitriol Injection 1 mcg/mL due to current good manufacturing practice (CGMP) violations. The manufacturer went out of business and could not complete required stability studies.
Akorn, Inc. has recalled all lots of Neomycin & Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment due to inability to complete required stability studies following the firm's business closure.
Akorn, Inc. is recalling all lots of Amantadine Hydrochloride Oral Solution (50mg/5mL) nationwide due to inability to complete required stability studies following the firm's closure, resulting in manufacturing quality deviations.
Ciclopirox 8% topical solution (nail lacquer) is recalled nationwide. The manufacturer went out of business and could not complete required stability testing to ensure product safety.
Akorn Operating Company is recalling all lots of Sodium Chloride Ophthalmic Solution (5%, 50mg/mL) nationwide because the firm went out of business and could not complete required stability studies to verify product safety and effectiveness.
Akorn Inc. is recalling all lots of Sufenta (Sufentanil Citrate Injection) distributed nationwide. The manufacturer ceased operations and could not complete required stability studies to verify drug safety and effectiveness over time.
Akorn, Inc. is recalling all lots of Hydrocortisone and Acetic Acid Otic Solution, USP (10 mL bottles) nationwide due to manufacturing deviations. The company ceased business and could not complete required stability studies to verify product quality.
Akorn, Inc. is recalling all lots of Lorazepam Oral Concentrate (2 mg/mL) due to Current Good Manufacturing Practice deviations. The manufacturer went out of business and could not complete required stability studies.
Akorn Inc. is recalling all lots of Oxcarbazepine Oral Suspension 300 mg/5 mL due to manufacturing practice deviations. The firm went out of business and could not complete required stability studies.
Akorn, Inc. is recalling all lots of Rifampin Capsules USP 150 mg distributed nationwide due to manufacturing deviations. The company ceased business before completing required stability studies to verify the drug remains safe and effective throughout its shelf life.
Akorn is recalling all lots of Artificial Tears Ointment nationwide due to manufacturing compliance deviations. The company went out of business and was unable to complete required stability studies.
Akorn, Inc. is recalling all lots of Hydromorphone Hydrochloride Injection due to CGMP deviations. The firm went out of business and could not complete required stability testing.
Akorn, Inc. is recalling all lots of Lidocaine HCl Jelly USP 2% in 5mL tubes nationwide due to manufacturing quality control violations. The company ceased operations and could not complete required stability testing.
Akorn Inc. is recalling all lots of Apraclonidine Ophthalmic Solution 0.5% due to manufacturing compliance deviations. The firm went out of business and could not complete required stability studies.
FDA is recalling all lots of DetomiSed (detomidine hydrochloride), a prescription-only drug, nationwide. Akorn Inc., the manufacturer, went out of business and could no longer conduct stability studies.
Akorn, Inc. is recalling all lots of Fentanyl Citrate Injection nationwide due to manufacturing compliance deviations. The company was unable to complete required stability studies after ceasing operations.
All lots of Trihexyphenidyl Hydrochloride Oral Solution (2mg/5mL) distributed nationwide have been recalled. The manufacturer went out of business and could not complete stability studies needed to verify the drug's safety over time.
Akorn, Inc. is recalling all lots of Tobramycin Ophthalmic Solution 0.3% because the manufacturer went out of business and could not complete required stability studies, a violation of manufacturing regulations.
Denison Pharmaceuticals recalls Pin-Away Pyrantel Pamoate pinworm treatment nationwide due to CGMP deviation: non-food-grade lubricant used in the manufacturing mixing vessel.
Akorn, Inc. is recalling all lots of Guaifenesin Oral Solution nationwide due to CGMP deviations. The manufacturer ceased operations before completing required stability testing to verify the product's safety and efficacy.
Fresenius Medical Care is recalling Sodium Chloride 0.9% Injection due to potential storage temperature exposure that may compromise sterility. The affected product includes 53,424 bags distributed to clinics in South Carolina, North Carolina, and Virginia.
Denison Pharmaceuticals is recalling Safe tussin DM DAY TIME Cough Relief due to use of non-food grade lubricant in the manufacturing process. Approximately 86,616 bottles were distributed nationwide.
Akorn, Inc. is recalling all lots of Artificial Tears Solution (Polyvinyl Alcohol 1.4%) nationwide due to CGMP compliance issues and inability to complete required stability studies after the firm went out of business.