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 17735

ModerateFDA (Drugs)·D-0419-2025·2025-05-21
La Roche-Posay Effaclar Duo Acne Treatment Recalled for Benzene
L'Oreal USA is voluntarily recalling all lots of La Roche-Posay Effaclar Duo Dual Action Acne Treatment due to detected trace levels of benzene in a specific lot.
Product
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, a) UPC 3606000508804, 20 mL (0.7 fl. oz.) Tube per Carton, b) 883140500759, 40 mL (1.35 fl. oz.) Tube per Carton, La Roche-Posay LLC, 10 Hudson Yards, New Yor
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0418-2025·2025-05-21
La Roche-Posay Effaclar Acne Treatment Kits Recalled Nationwide
L'Oreal USA is recalling La Roche-Posay Effaclar 3-Step Acne Routine Kits nationwide due to trace levels of benzene detected in one lot. As a precaution, all Effaclar Duo Dual Action Acne Treatment lots are included in the recall.
Product
La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step Acne Routine Kit, Medicated Gel Cleanser 3.4 fl. oz. (100 mL) Tube, Clarifying Solution 3.4 fl. oz. (100 mL) Tube, Dual Action Acne Treatment 0.7 fl. oz. (20 mL: UPC 883140035275) Tube, (benzoyl
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0417-2025·2025-05-21
La Roche-Posay Effaclar Duo Acne Treatment Recalled for Benzene Contamination
La Roche-Posay Effaclar Duo acne treatment is being recalled due to detected trace levels of benzene. The recall affects 2,226,801 units distributed nationwide.
Product
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, 40 mL (135 FL. OZ.) Tube per carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, Laboratoire Dermatologique, CAI 86270, La Roche-
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0413-2025·2025-05-14
Testosterone Pellet 200 mg Recalled for Glass Particle Contamination
BSO LLC is recalling compounded testosterone pellets nationwide because glass particles were found in vials. Affected lot numbers are 20250207@1 and 20250228@1 (expiration 1/31/2026).
Product
TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0125-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0406-2025·2025-05-14
Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
BRS Analytical Services is recalling Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% eye lubricant nationwide due to cGMP deviations and lack of assurance of sterility. The recalled product was distributed in 0.5 FL OZ dropper bottles across multiple lots with various expiration dates in 2025 and 2026.
Product
CARBOXYMETHYLCELLULOSE SODIUM — CARBOXYMETHYLCELLULOSE SODIUM (CARBOXYMETHYLCELLULOSE SODIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0405-2025·2025-05-14
Carboxymethylcellulose Sodium Ophthalmic Gel recalled for sterility concerns
BRS Analytical Services is recalling Carboxymethylcellulose Sodium Ophthalmic Gel 1% eye lubricant due to current Good Manufacturing Practice (cGMP) deviations and lack of assurance of sterility.
Product
Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0415-2025·2025-05-14
Testosterone Pellet 200 mg Recalled Due to Glass Particles
BSO LLC is recalling Testosterone Pellet 200 mg compounded drug vials nationwide due to the presence of glass particles found in pellet vials.
Product
TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0122-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0404-2025·2025-05-14
Artificial Tears Eye Drops Recalled for Manufacturing and Sterility Issues
BRS Analytical Services is recalling Artificial Tears ophthalmic solution (0.5 FL OZ dropper bottles) nationwide due to manufacturing deviations and lack of assured sterility. Affected lots are Lot 126–129, 162–170, and 193–199.
Product
ARTIFICIAL TEARS — ARTIFICIAL TEARS (ARTIFICIAL TEARS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0407-2025·2025-05-14
Lubricant Eye Drops Solution recalled due to sterility assurance concerns
BRS Analytical Services is recalling Lubricant Eye Drops Solution (Polyethylene Glycol 400 and Propylene Glycol) due to manufacturing deviations and lack of assurance of sterility. The product was distributed nationwide.
Product
LUBRICANT EYE DROPS SOLUTION — LUBRICANT EYE DROPS SOLUTION (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0402-2025·2025-05-14
Ropivacaine Hydrochloride Injection Recalled for Particulate Matter
Amneal Pharmaceuticals is recalling Ropivacaine Hydrochloride Injection 0.5% due to the presence of particulate matter. The recall affects specific lots distributed nationwide.
Product
ROPIVACAINE HYDROCHLORIDE — ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0408-2025·2025-05-14
Polyvinyl Alcohol Eye Drops Recalled for Manufacturing and Sterility Issues
BRS Analytical Services is recalling Polyvinyl Alcohol Ophthalmic Solution 1.4% eye drops nationwide due to cGMP deviations and lack of assurance of sterility.
Product
POLYVINYL ALCOHOL — POLYVINYL ALCOHOL (POLYVINYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0416-2025·2025-05-14
Testosterone Pellet 200 mg Recalled for Glass Particulate Matter
BSO LLC is recalling Testosterone Pellet 200 mg compounded drug vials nationwide because glass particles were found in the pellets intended for subcutaneous injection.
Product
TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0121-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0409-2025·2025-05-14
FentaNYL and Ropivacaine Epidural Injection Recalled Due to Sterility Concerns
Apollo Care, LLC is recalling FentaNYL 500mcg/2mcg/mL and Ropivacaine HCl 250mg/0.1% epidural injection due to lack of assurance of sterility. The recall affects 440 bags of a single lot distributed in Missouri.
Product
FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0414-2025·2025-05-14
Testosterone Pellet 200 mg Recalled for Glass Particulate Matter
BSO LLC is recalling Testosterone Pellet 200 mg vials nationwide due to the presence of glass particles found in pellet vials. Patients should contact their healthcare provider.
Product
TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0124-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0403-2025·2025-05-14
Timolol Maleate Ophthalmic Solution Recalled for Defective Container
FDC Limited is recalling Timolol Maleate Ophthalmic Solution 0.5% due to a defective container where the spike of the cap becomes lodged in the bottle nozzle, preventing users from accessing the solution.
Product
TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0411-2025·2025-05-14
Clindamycin HCl Capsule 300 mg repackaged by RemedyRePack Inc.
RemedyRePack Inc. is recalling Clindamycin HCl Capsule, 300 mg, due to current Good Manufacturing Practice (CGMP) deviations—the products were manufactured in a shared facility with Ezetimibe tablets.
Product
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
Category
Drug
Distribution
3 states
ModerateFDA (Drugs)·D-0410-2025·2025-05-14
Homeopathic Oral Spray Temper Tamer Recalled for CGMP Deviations
Siddha Flower Essences is voluntarily recalling Temper Tamer homeopathic oral spray due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.
Product
temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030 NDC 69779-020-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0412-2025·2025-05-14
Testosterone Pellet 100 mg recalled due to glass particle contamination
BSO LLC is recalling Testosterone Pellet 100 mg (compounded, office use only) distributed nationwide due to glass particles found in pellet vials.
Product
TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0101-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0398-2025·2025-05-07
Nicardipine Hydrochloride Injection Recalled for Potential Sterility Issues
American Regent, Inc. is recalling Nicardipine Hydrochloride Injection due to product leakage around the vial neck that could compromise sterility assurance. The recall affects multiple lots distributed nationwide.
Product
NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0399-2025·2025-05-07
Nicardipine Hydrochloride Injection Recalled for Potential Sterility Loss
American Regent, Inc. is recalling certain lots of Nicardipine Hydrochloride Injection due to product leakage around the vial neck that could compromise sterility assurance. The recall affects 7,249 cartons distributed nationwide.
Product
NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0396-2025·2025-05-07
Levothyroxine Sodium Tablets 88 mcg Recall for Subpotency
Accord Healthcare is recalling Levothyroxine Sodium Tablets 88 mcg (Lot D2300044, expiring 12/2025) nationwide because the tablets are subpotent—below the required strength. Patients on this medication should contact their pharmacy or prescriber.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0390-2025·2025-05-07
Tirofiban Hydrochloride Injection recalled for out-of-specification test results
Eugia US LLC is recalling Tirofiban Hydrochloride Injection due to out-of-specification test results for related substances found during a three-month stability study under long-term storage conditions.
Product
TIROFIBAN — TIROFIBAN (TIROFIBAN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0392-2025·2025-05-07
Dexonto 0.4% Dexamethasone Solution Recalled for Incorrect Expiration Dating
Nubratori, Inc. is recalling Dexonto 0.4% dexamethasone sodium phosphate solution because some outer boxes are labeled with an incorrect expiration date (12/25/2025 instead of 12/25/2024), creating risk of use after actual expiration.
Product
Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX, 381 Van Ness Ave# 1507, CA 90501, NDC 71300-6564-1 (box)
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0394-2025·2025-05-07
Levothyroxine Sodium Tablets Recalled for Subpotency by Accord Healthcare
Accord Healthcare is recalling 4,888 bottles of Levothyroxine Sodium Tablets (25 mcg) nationwide due to subpotency. The affected lot is D2300323 with expiration date 01/2026.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0400-2025·2025-05-07
Medroxyprogesterone Acetate Injectable Suspension Recalled Due to Cold Chain Disruption
Medroxyprogesterone Acetate Injectable Suspension (150 mg/mL) distributed to medical facilities in Mississippi and Florida is recalled because severe thunderstorms caused shipping delays that may have compromised the product's storage conditions and safety.
Product
Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-0330-01
Category
Drug
Distribution
2 states

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1051–1075 of 17735