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

1926–1950 of 11852

HighFDA (Drugs)·D-0498-2023·2023-04-12
Drug recall: Atorvastatin 20 mg tablets due to manufacturing process deviations
RemedyRepack Inc. is recalling 3,426 bottles of Atorvastatin 20 mg tablets nationwide due to Good Manufacturing Practice (cGMP) deviations. The recall was initiated voluntarily by the manufacturer.
Product
Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0475-2023·2023-04-05
Calcitonin Salmon Nasal Spray Recalled for Out-of-Specification Impurities and Low Potency
Endo Pharmaceuticals is recalling Calcitonin Salmon Nasal Spray due to out-of-specification impurities and subpotent drug content. Affected lots distributed nationwide have expiration dates ranging from March 2023 to March 2025.
Product
CALCITONIN SALMON — CALCITONIN SALMON (CALCITONIN SALMON)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0487-2023·2023-04-05
Apollo Care Fentanyl and Ropivacaine Epidural Injection Recalled for Contamination
Apollo Care is recalling 215 bags of Fentanyl and Ropivacaine epidural injection (Lot AC-016581) due to suspected microbial growth on external packaging. The recall affects product distributed in Missouri.
Product
Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0533-2023·2023-04-05
Dabigatran Etexilate Drug Recalled Due to N-nitroso Impurity
Ascend Laboratories is recalling 13,560 bottles of Dabigatran Etexilate 75 mg capsules nationwide because testing detected N-nitroso-dabigatran impurity levels above acceptable limits. The issue stems from a manufacturing quality control deviation.
Product
DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0534-2023·2023-04-05
Prescription Drug Dabigatran Etexilate Recalled for Excess Nitrosamine Impurity
Ascend Laboratories is recalling 12,804 bottles of Dabigatran Etexilate 150mg capsules nationwide due to detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake limit caused by manufacturing process deviations.
Product
DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0479-2023·2023-04-05
Ropinirole 1 mg Tablets Recalled Nationwide for Manufacturing Process Deviations
Direct Rx is recalling Ropinirole 1 mg tablets nationwide due to manufacturing process deviations. Consult a pharmacist before stopping this medication.
Product
Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0481-2023·2023-04-05
FDA Recalls Glimepiride Tablets Due to Manufacturing Quality Violations
Direct Rx is voluntarily recalling Glimepiride 2 mg tablets nationwide due to manufacturing practice violations. The recall affects multiple lot numbers of 30-count and 90-count bottles distributed across the United States.
Product
Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0488-2023·2023-03-29
Delsam Pharma Artificial Eye Ointment Recalled for Bacterial Contamination
Delsam Pharma's Artificial Eye Ointment is being recalled for bacterial contamination in unopened tubes. FDA analysis found non-sterility defects in approximately 50,000 units.
Product
Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0471-2023·2023-03-29
Daytrana Methylphenidate Patches Recalled for Defective Transdermal Delivery System
Noven Pharmaceuticals is recalling specific lots of Daytrana (methylphenidate) transdermal patches due to a defective delivery system that is out of specification for shear. Affected lots are Lot 91956 (6/2023) and Lot 92475 (7/2023), distributed nationwide.
Product
DAYTRANA — DAYTRANA (METHYLPHENIDATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0473-2023·2023-03-29
Daytrana Methylphenidate Transdermal Patches Recalled for Defective Delivery System
Noven Pharmaceuticals recalls Daytrana (methylphenidate) 30 mg transdermal patches nationwide due to defective delivery system components that fail shear specifications. Patients should contact their healthcare provider regarding medication alternatives.
Product
DAYTRANA — DAYTRANA (METHYLPHENIDATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0472-2023·2023-03-29
Daytrana methylphenidate patches recalled for defective delivery system
Noven Pharmaceuticals is recalling Daytrana methylphenidate transdermal patches for a defective delivery system that fails to meet shear specifications. The recall affects specific lots distributed nationwide.
Product
DAYTRANA — DAYTRANA (METHYLPHENIDATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0468-2023·2023-03-29
Prescription Drug Recall: Jardiance Empagliflozin 25 mg Label Mix-Up
Boehringer Ingelheim Pharmaceuticals is recalling Jardiance (Empagliflozin) 25 mg tablets due to a label mix-up affecting 69,375 bottles distributed nationwide.
Product
JARDIANCE — JARDIANCE (EMPAGLIFLOZIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0458-2023·2023-03-22
Alprazolam Tablets Recalled for Potential Cross-Contamination Risk
Breckenridge Pharmaceuticals is recalling Alprazolam Tablets, USP 0.25mg distributed nationwide due to a potential cross-contamination risk from manufacturing deviations.
Product
Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c) 1,000-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berli
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0469-2023·2023-03-22
Eye allergy medication recalled for out-of-specification impurity
Teva Pharmaceuticals is recalling 715,632 bottles of Clear Eyes Once Daily eye drops due to an out-of-specification impurity found during stability testing.
Product
Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 fl oz) bottle, Sterile, Distributed by Medtech Products Inc. Tarrytown, NY 10591, A Prestige Consumer Healthcare company, Made in Israel, UPC 67
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0460-2023·2023-03-22
Alprazolam Tablets Recalled for Potential Cross-Contamination from Manufacturing Deviations
Breckenridge Pharmaceutical is recalling Alprazolam 1 mg tablets distributed nationwide due to manufacturing practice deviations that pose a potential cross-contamination risk.
Product
Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c) 1,000-count bottle (NDC 51991-0706-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Bre
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0459-2023·2023-03-22
Alprazolam Tablets Recalled Due to Potential Cross-Contamination Risk
Breckenridge Pharmaceutical is recalling multiple lots of Alprazolam 0.5mg tablets nationwide due to manufacturing process deviations that created a potential cross-contamination risk.
Product
Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 51991-0705-05) and c) 1,000-count bottle (NDC 51991-0705-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: B
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0463-2023·2023-03-22
Clobazam Tablets Recalled Due to Cross Contamination Risk
Breckenridge Pharmaceutical is recalling Clobazam 20 mg tablets (Lot #5210147, exp. 12/2023) nationwide due to potential cross contamination from manufacturing deviations.
Product
Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-901-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0461-2023·2023-03-22
Alprazolam Tablets Recalled for Potential Cross-Contamination from Manufacturing Deviations
Breckenridge Pharmaceuticals is recalling Alprazolam 2 mg tablets nationwide due to manufacturing practice deviations creating potential cross-contamination risk. Affected tablets are distributed in 100-count and 500-count bottles.
Product
Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC 51991-0707-05), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0455-2023·2023-03-15
Hand Sanitizer Recalled for Methanol and Acetaldehyde Contamination
Snowy Range Blue hand sanitizer is recalled due to FDA findings of methanol, acetaldehyde, and acetal above permissible limits. The product was distributed nationwide across all lot codes.
Product
Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distributed by Reliable Products, LLC, Cheyenne, WY 82003, NDC 75288-100-04.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0456-2023·2023-03-15
Drug Recall: Pharmedica Non-Sterile MSM Drops Due to Contamination
Pharmedica USA recalled Purely Soothing 15% MSM Drops nationwide due to non-sterility concerns. The voluntary Class I recall affects approximately 1,904 bottles distributed via e-commerce and trade shows.
Product
Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7 31034 91379 9; Manufactured by: Pharmedica USA, Phoenix, AZ.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0445-2023·2023-03-15
FDA Recalls Phenylephrine IV Solution for Manufacturing Practice Deviations
Denver Solutions recalls 8,136 units of Phenylephrine HCl IV solution nationwide due to manufacturing practice deviations. The FDA classified this Class II recall as affecting prescription injectable solutions distributed to hospitals and government facilities.
Product
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0434-2023·2023-03-15
Heparin Sodium in Dextrose Injection Recalled for Low Anticoagulant Potency
B. Braun Medical Inc. is recalling Heparin Sodium in Dextrose Injection (Lot J2C017) due to subpotent anti-Factor IIa activity, which may reduce anticoagulant effectiveness.
Product
HEPARIN SODIUM IN DEXTROSE — HEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0439-2023·2023-03-15
NaturalCare bioAllers Homeopathic Drops Recalled for Manufacturing Quality Defect
Nutraceutical Corporation is recalling NaturalCare bioAllers homeopathic liquid drops nationwide due to a raw material manufacturing quality issue. The recall affects lot 222076 with an expiration date of 03/27.
Product
NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd. for Nutraceutical Corp. NaturalCare Park City, UT, 84098 USA
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0436-2023·2023-03-15
Verapamil Hydrochloride Tablets Recalled for Failed Dissolution Specification
Amerisource Health Services LLC is recalling 422 cartons of Verapamil Hydrochloride Extended-Release Tablets, 120 mg due to failed dissolution testing. The tablets did not meet specifications for drug release.
Product
Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0444-2023·2023-03-15
FDA Drug Recall: Phenylephrine IV Bags Recalled for Manufacturing Deviations
Denver Solutions recalls 1,212 units of Phenylephrine HCl IV bags nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall affects products distributed across the U.S. including government facilities.
Product
Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82
Category
Drug
Distribution
Distributed nationwide

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1926–1950 of 11852