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

1051–1075 of 17978

SevereFDA (Drugs)·D-0453-2025·2025-06-04
Endurance Boost With Horny Goat Weed Supplement Recalled for Undisclosed Drug Content
VEPEMVA Nutrition's Endurance Boost with Horny Goat Weed has been recalled because it contains Sildenafil and Propoxyphenylsildenafil, undisclosed active pharmaceutical ingredients. The product was marketed and sold without FDA approval.
Product
ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance, UPC X004BB9Z8N
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0451-2025·2025-06-04
Carvedilol Tablets 25 mg Recalled Due to Impurity Above Acceptable Limit
Glenmark Pharmaceuticals is recalling Carvedilol Tablets USP 25 mg nationwide due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit, resulting from CGMP deviations.
Product
CARVEDILOL — CARVEDILOL (CARVEDILOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0452-2025·2025-06-04
Theophylline Extended-Release Tablets recalled for dissolution test failure
Glenmark Pharmaceuticals is recalling Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, due to out-of-specification results on dissolution testing. The recall affects 8,520 bottles distributed nationwide.
Product
THEOPHYLLINE — THEOPHYLLINE (THEOPHYLLINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0447-2025·2025-06-04
Bromfenac Ophthalmic Solution 0.09% Recalled for Failed Impurities Specifications
Alembic Pharmaceuticals Limited is recalling Bromfenac Ophthalmic Solution 0.09% nationwide due to failed impurities and degradation specifications. Three affected lots expire May 31, 2025.
Product
BROMFENAC OPHTHALMIC SOLUTION 0.09% — BROMFENAC OPHTHALMIC SOLUTION 0.09% (BROMFENAC OPHTHALMIC SOLUTION 0.09%)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0442-2025·2025-05-28
Esomeprazole Magnesium Oral Suspension Recalled for Failed Impurity Specifications
Zydus Pharmaceuticals is recalling Esomeprazole Magnesium 40 mg delayed-release oral suspension because out-of-specification test results were found for unknown degradation products during stability testing.
Product
ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0441-2025·2025-05-28
ChloraPrep One-Step Applicators Recalled Due to Compromised Sterile Packaging
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators nationwide because affected units may have open seals on the packaging, compromising sterility assurance.
Product
CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0444-2025·2025-05-28
AIRSUPRA Albuterol and Budesonide Inhalation Aerosol Recalled for Defective Delivery System
AstraZeneca is recalling AIRSUPRA (albuterol sulfate and budesonide) inhalation aerosol due to a defective delivery system. The recall affects multiple lot numbers and expiration dates distributed nationwide.
Product
AIRSUPRA — AIRSUPRA (ALBUTEROL SULFATE AND BUDESONIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0435-2025·2025-05-28
Nature Mint Anticavity Fluoride Toothpaste Recalled for CGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 19,500 tubes distributed in Delaware and North Carolina.
Product
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 4.6 OZ (130 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-06
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0430-2025·2025-05-28
Cinnafresh Anticavity Gel Toothpaste Recalled Due to CGMP Deviations
Cinnafresh anticavity gel toothpaste (sodium fluoride 0.22%, Bold Cinnamon Flavor) is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer, KENIL HEALTHCARE PRIVATE LIMITED, initiated this voluntary recall.
Product
Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-01
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0438-2025·2025-05-28
Nature Mint Anticavity Fluoride Toothpaste Recall Due to Manufacturing Deviations
KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste (0.85 oz tubes) distributed in Delaware and North Carolina due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-03
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0423-2025·2025-05-28
Antifungal Cream Recalled for Manufacturing Deviations
Kenil Healthcare is recalling CURA HONGOS Antifungal Cream (Clotrimazole 1%, 2 oz tubes) distributed in Delaware and North Carolina due to CGMP (Current Good Manufacturing Practice) deviations detected during manufacturing.
Product
CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 997110 011052.
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0432-2025·2025-05-28
Maximum Security Anticavity Gel Toothpaste recalled for CGMP deviations
Maximum Security Anticavity Gel Toothpaste is being recalled due to Current Good Manufacturing Practice (CGMP) deviations identified by the manufacturer. The recall affects toothpaste tubes distributed in Delaware and North Carolina.
Product
Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made in India, Dist. by Bob Barker Co. Inc. Fuquay-Varnia, NC 27526, NDC 53247-132-03
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0436-2025·2025-05-28
Nature Mint Anticavity Fluoride Toothpaste Recall Due to CGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED is voluntarily recalling Nature Mint Anticavity Fluoride Toothpaste due to Current Good Manufacturing Practice (CGMP) deviations. The affected toothpaste was distributed in Delaware and North Carolina.
Product
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-02
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0443-2025·2025-05-28
Esomeprazole Magnesium oral suspension recalled for failed impurity specifications
Zydus Pharmaceuticals is recalling Esomeprazole Magnesium delayed-release oral suspension, 20 mg, due to out-of-specification test results for unknown degradation products detected during long-term stability testing.
Product
ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0428-2025·2025-05-28
Rapidol Hydrocortisone 1% Anti-Itch Cream Recalled for CGMP Deviations
Kenil Healthcare is recalling 10,000 tubes of Rapidol Maximum Strength Hydrocortisone 1% Anti-Itch Cream (2 oz, Lot SP26A, Expiration 09/30/2026) distributed in Delaware and North Carolina due to manufacturing quality issues.
Product
RAPIDOL — RAPIDOL (HYDROCORTISONE)
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0427-2025·2025-05-28
Optim V Anti-Itch Cream Recalled for Current Good Manufacturing Practice Deviations
Optim V Anti-Itch Cream (Benzocaine 20% & Resorcinol 3%) is being recalled because the manufacturer did not follow current good manufacturing practice (CGMP) standards. The voluntary recall affects 6,372 tubes distributed in Delaware and North Carolina.
Product
Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto 1 oz (28g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-300-01, UPC 8 59424 00420 6.
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0424-2025·2025-05-28
Kingskin SacaCallos salicylic acid solution recalled for manufacturing deviations
Kingskin SacaCallos 17% salicylic acid bottles are being recalled due to manufacturing deviations. The firm initiated the voluntary recall affecting approximately 9,000 bottles distributed in Delaware and North Carolina.
Product
Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-423-15, UPC 8 10096 77163 6.
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0433-2025·2025-05-28
Maximum Security Anticavity Toothpaste Sachets Recalled for CGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED is recalling Maximum Security Anticavity Gel Toothpaste sachets distributed in Delaware and North Carolina due to Current Good Manufacturing Practice (CGMP) deviations identified by the FDA.
Product
Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15 OZ (4.25 g) Sachets, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-01
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0446-2025·2025-05-28
Phentermine Hydrochloride Capsules 30mg Recalled for cGMP Deviations
KVK Tech, Inc. is recalling 9,680 bottles of Phentermine Hydrochloride Capsules 30mg nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall is voluntary and firm-initiated.
Product
PHENTERMINE HYDROCHLORIDE — PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0426-2025·2025-05-28
KOFAL Methyl Salicylate External Analgesic Ointment Recall
KOFAL Athletes Penetrating Pain Relief external analgesic ointment (methyl salicylate 10.5%) is being recalled due to CGMP deviations in manufacturing. The voluntary recall affects 11,808 jars distributed in Delaware and North Carolina.
Product
KOFAL — KOFAL (METHYL SALICYLATE)
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0445-2025·2025-05-28
Indomethacin Extended-Release Capsules Recalled for cGMP Deviations
KVK Tech, Inc. is recalling Indomethacin Extended-Release Capsules USP, 75 mg (Lot #18400A) nationwide due to cGMP deviations. The recall affects approximately 9,107 bottles distributed nationwide.
Product
INDOMETHACIN — INDOMETHACIN (INDOMETHACIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0429-2025·2025-05-28
Rapidol Triple Antibiotic Ointment Recalled for CGMP Deviations
Rapidol Triple Antibiotic First Aid Ointment (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate) distributed in Delaware and North Carolina is being recalled for CGMP deviations. The manufacturer initiated a voluntary recall of 9,336 tubes.
Product
RAPIDOL — RAPIDOL (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE)
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0421-2025·2025-05-28
Artridon Topical Analgesic Recalled for Manufacturing Process Deviations
Kenil Healthcare is recalling 9,984 tubes of Artridon topical analgesic (menthol and methyl salicylate) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects units distributed in Delaware and North Carolina.
Product
ARTRIDON — ARTRIDON (MENTHOL, METHYL SALICYLATE)
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0440-2025·2025-05-28
Nature Mint Anticavity Fluoride Toothpaste Recall CGMP Deviations
Nature Mint Anticavity Fluoride Toothpaste (0.76% sodium monofluorophosphate, 2.75 OZ tube) is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The affected lots were distributed in Delaware and North Carolina.
Product
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-05
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0422-2025·2025-05-28
Antifungal Drug Recalled for Manufacturing Process Deviations
Pharmadel LLC is recalling CURA HONGOS 1% Clotrimazole topical lotion due to Current Good Manufacturing Practice (CGMP) deviations identified during production. The voluntary recall affects approximately 10,128 bottles distributed in Delaware and North Carolina.
Product
CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-34-01, UPC 8 10096 77170 4.
Category
Drug
Distribution
2 states

How to read this listing

Filters

1051–1075 of 17978