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

2851–2875 of 17762

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-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
ModerateFDA (Drugs)·D-0486-2023·2023-04-05
Simvastatin Tablets Recalled Nationwide Over Manufacturing Practice Deviations
Direct Rx is recalling 269 bottles of Simvastatin 40 mg nationwide due to Good Manufacturing Practice deviations. No adverse events have been reported. Consult your healthcare provider before changing your medication.
Product
Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0484-2023·2023-04-05
Drug Manufacturer Recalls Simvastatin Tablets for Manufacturing Deviations
Direct Rx recalled Simvastatin 10 mg tablets nationwide due to manufacturing process deviations discovered during production. No illnesses or injuries have been reported.
Product
Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0480-2023·2023-04-05
Drug Recall: Glimepiride Tablets Due to Manufacturing Deviations
Direct Rx is recalling Glimepiride, USP, 1 mg Tablets nationwide due to cGMP deviations. The firm-initiated recall impacts both 30-count and 90-count bottles distributed across the USA.
Product
Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0485-2023·2023-04-05
Simvastatin 20mg Tablets Recalled for Manufacturing Practice Deviations
Direct Rx recalled Simvastatin 20mg tablets nationwide due to manufacturing practice deviations. The voluntary recall affects bottles distributed across the United States.
Product
Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0477-2023·2023-04-05
Finasteride Tablets Recalled Nationwide for Manufacturing Practice Deviations
Direct Rx is recalling 19 bottles of Finasteride 5 mg Tablets nationwide due to cGMP deviations. The firm initiated this recall voluntarily.
Product
Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0483-2023·2023-04-05
Drug Recall: Simvastatin 5 mg tablets due to manufacturing compliance violations
Direct Rx is recalling 51 bottles of Simvastatin 5 mg tablets nationwide due to Good Manufacturing Practice deviations. The recall is voluntary and was initiated in March 2023.
Product
Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0476-2023·2023-04-05
Drug Recall: Montelukast Sodium Tablets Due to Manufacturing Deviations
Direct Rx is recalling Montelukast Sodium 10 mg tablets nationwide due to manufacturing process deviations. The voluntary recall affects approximately 508 bottles distributed across the United States.
Product
Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0482-2023·2023-04-05
Glimepiride tablet recall due to manufacturing practice deviations
Direct Rx is recalling Glimepiride 4 mg tablets nationwide due to manufacturing process deviations. The recall is voluntary and affects specific lots of 30-count and 90-count bottles.
Product
Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0478-2023·2023-04-05
Prescription Drug Ropinirole 0.25 mg Tablets Recalled for Manufacturing Deviations
Direct Rx is recalling Ropinirole, USP, 0.25 mg tablets (NDC 72189-0364-30, Lot 21JU2210) nationwide due to Good Manufacturing Practice (cGMP) deviations. The firm voluntarily initiated this recall on March 13, 2023.
Product
Ropinirole, USP, 0.25 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
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-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-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-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
ModerateFDA (Drugs)·D-0474-2023·2023-03-29
Dofetilide Capsules Recalled for Failed Content Uniformity Specifications
Sun Pharmaceutical is recalling 1,920 bottles of Dofetilide Capsules (500 mcg) nationwide due to failed content uniformity specifications, meaning the capsules do not contain uniform amounts of active ingredient.
Product
Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0470-2023·2023-03-29
Daytrana Methylphenidate Patches Recalled for Defective Delivery System
Noven Pharmaceuticals is recalling specific lots of Daytrana methylphenidate transdermal patches distributed nationwide because the delivery system is out of specification for shear. The affected lots require patient and healthcare provider attention.
Product
DAYTRANA — DAYTRANA (METHYLPHENIDATE)
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-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-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-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

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