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

51–75 of 669

SevereFDA (Drugs)·D-0223-2025·2025-02-12
Adrenalin Chloride Epinephrine Nasal Solution Recalled for Misleading Label
Par Pharmaceutical is recalling Adrenalin Chloride Solution (Epinephrine Nasal Solution) due to a misleading label that resembles the FDA-approved Adrenalin epinephrine injection product, creating potential confusion.
Product
Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01
Category
Drug
Distribution
Distributed nationwide
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
SevereFDA (Drugs)·D-0210-2025·2025-02-05
FDA Class I Recall: Astagraf XL Immunosuppressant Capsules May Be Empty
Astellas Pharma is recalling Astagraf XL (tacrolimus) due to manufacturing defects; bottles shipped nationwide may contain empty capsules instead of medication.
Product
ASTAGRAF XL — ASTAGRAF XL (TACROLIMUS EXTENDED-RELEASE CAPSULES)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0207-2025·2025-01-29
FOUZEE SugarLin Herbal Formula Capsules Recalled for Undeclared Prescription Drugs
Shoppers-Plaza is recalling FOUZEE SugarLin Herbal Formula capsules because FDA testing found undeclared metformin and glyburide. The product was marketed without FDA approval.
Product
FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0200-2025·2025-01-22
Systane Lubricant Eye Drops Recalled for Non-Sterility Risk
Alcon Research is voluntarily recalling Systane Lubricant Eye Drops, Ultra PF, due to non-sterility concerns. The recall affects 55,960 boxes distributed nationwide.
Product
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0179-2025·2025-01-15
Clonazepam Orally Disintegrating Tablets Carton Mislabeled on Declared Strength
Endo USA recalls 8,029 cartons of Clonazepam 0.125 mg tablets nationwide due to incorrect carton labeling, although the tablets in the blister strips have the correct strength.
Product
CLONAZEPAM — CLONAZEPAM (CLONAZEPAM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0181-2025·2025-01-15
Clonazepam Tablets Recalled Due to Carton Labeling Error
Endo USA, Inc. is recalling 22,513 cartons of clonazepam tablets due to incorrect strength labeling on some carton exteriors. The actual tablets inside have correct labeling.
Product
CLONAZEPAM — CLONAZEPAM (CLONAZEPAM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0180-2025·2025-01-15
Clonazepam Tablets Recalled Due to Incorrect Carton Labeling
Endo USA recalls clonazepam tablets because some cartons are labeled with incorrect declared strength. The medication inside the blister strips contains the correct strength.
Product
CLONAZEPAM — CLONAZEPAM (CLONAZEPAM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0177-2025·2025-01-15
Herbal Capsules Recalled Nationwide for Undeclared Pharmaceutical Ingredients
Herbal capsules sold nationwide have been recalled after the FDA found undeclared medications inside. The product contained furosemide, dexamethasone, and chlorpheniramine without proper labeling.
Product
Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang, Malasia.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0178-2025·2025-01-15
Clonazepam tablets recalled for incorrect carton labeling
Endo USA is recalling approximately 9,816 cartons of Clonazepam 2 mg tablets due to incorrect strength labeling on the carton exterior. The blister strips inside contain the correct formulation.
Product
CLONAZEPAM — CLONAZEPAM (CLONAZEPAM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0170-2025·2025-01-08
FORCE FOREVER supplement tablets recalled for undisclosed drugs
GNMart LLC is recalling FORCE FOREVER 400mg tablets nationwide after the FDA found the product contains undisclosed Diclofenac and Dexamethasone. The Class I recall affects all lots of this dietary supplement product.
Product
FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0085-2025·2024-12-11
ZoomMax Capsules contain undeclared sildenafil and diclofenac
ZoomMax Capsules have been recalled by the FDA due to containing undeclared sildenafil and diclofenac. The product was marketed without FDA approval.
Product
ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0086-2025·2024-12-11
ZapMax Capsules Recalled for Undeclared Sildenafil and Diclofenac
ZapMax Capsules, 500 mg are recalled for containing undeclared sildenafil and diclofenac without FDA approval. The product was distributed nationwide; consumers should stop using immediately and consult their healthcare provider.
Product
ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0084-2025·2024-12-11
PeakMax Capsules Recalled for Undeclared Sildenafil and Diclofenac
PeakMax Capsules contain undeclared sildenafil and diclofenac and were marketed without FDA approval. This Class I recall affects capsules distributed nationwide.
Product
PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0083-2025·2024-12-11
VitalityXtra Capsules Recalled for Undeclared Sildenafil and Diclofenac
VitalityXtra Capsules containing undeclared sildenafil and diclofenac are being recalled nationwide. The product was marketed without required FDA approval and poses health risks from undeclared pharmaceutical ingredients.
Product
VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0040-2025·2024-11-13
Ascorbic Acid Injection Recalled Nationwide for Glass Contamination
Staska Pharmaceuticals recalled ascorbic acid injectable solution due to glass contamination. The FDA classified the recall as Class I; 4,773 vials nationwide were affected.
Product
Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0012-2025·2024-10-23
Atovaquone Oral Suspension Recalled for Cohnella Bacteria Contamination
Bionpharma Inc. is recalling Atovaquone Oral Suspension (750 mg/5 mL) nationwide due to Cohnella bacteria contamination. The recall affects 1,980 bottles.
Product
ATOVAQUONE — ATOVAQUONE (ATOVAQUONE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0008-2025·2024-10-16
Vail-Bon Jie Yang Wan capsules recalled for undeclared pharmaceutical ingredients
Vail-Bon Jie Yang Wan capsules have been recalled for containing undeclared dexamethasone and chlorpheniramine. The product was marketed without FDA approval.
Product
Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0003-2025·2024-10-09
Hard Steel Capsules Recalled for Undeclared Acetaminophen and Sildenafil
Hard Steel Capsules contain undeclared acetaminophen and sildenafil and were marketed without FDA approval. All 729 units distributed nationwide and internationally are included in the recall.
Product
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0004-2025·2024-10-09
Gold Hard Steel Plus Liquid recalled for undeclared acetaminophen and sildenafil
FDA has recalled Gold Hard Steel Plus Liquid because the product was marketed without FDA approval and contains undeclared pharmaceutical ingredients: acetaminophen and sildenafil.
Product
Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0005-2025·2024-10-09
FDA Recalls Veklury Injection Vials for Presence of Glass Particles
Gilead Sciences recalls 105,000 vials of Veklury (remdesivir) for injection nationwide because glass particles are present in the medication.
Product
VEKLURY — VEKLURY (REMDESIVIR)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0649-2024·2024-09-11
FDA Recalls Heparin Sodium Injection for Endotoxin Contamination
Baxter Healthcare Corporation is recalling 44,208 containers of Heparin Sodium in Sodium Chloride Injection nationwide after endotoxin testing revealed out-of-limit results. The contamination poses a risk of serious adverse reactions in patients receiving the intravenous medication.
Product
HEPARIN SODIUM IN SODIUM CHLORIDE — HEPARIN SODIUM IN SODIUM CHLORIDE (HEPARIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0638-2024·2024-08-28
FDA Class I Recall: B. Braun Sodium Chloride Injection for Particulate Matter
B. Braun Medical Inc. is recalling 63,444 containers of 0.9% Sodium Chloride Injection USP nationwide due to the presence of particulate matter. This intravenous medication may pose a serious health risk if administered to patients.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0641-2024·2024-08-28
Acetaminophen Aspirin Caffeine Tablets Recalled for Missing Drug Facts Labels
Aurohealth LLC is recalling Acetaminophen, Aspirin and Caffeine tablets because some bottles are missing the manufacturer's label containing drug facts information. Affected product was distributed in NJ, NY, and PA.
Product
ACETAMINOPHEN ASPIRIN AND CAFFEINE — ACETAMINOPHEN ASPIRIN AND CAFFEINE (ACETAMINOPHEN, ASPIRIN AND CAFFEINE)
Category
Drug
Distribution
3 states
SevereFDA (Drugs)·D-0635-2024·2024-08-28
FDA Recalls Acetaminophen Injection Due to Labeling Mix-up
Hikma Pharmaceuticals is recalling Acetaminophen Injection because bags of Dexmedetomidine HCl were found packaged inside Acetaminophen-labeled overWraps. The error could result in patients receiving the wrong intravenous medication.
Product
ACETAMINOPHEN — ACETAMINOPHEN (ACETAMINOPHEN)
Category
Drug
Distribution
2 states

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