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

1426–1450 of 17964

HighFDA (Drugs)·D-0077-2025·2024-12-11
FDA Recalls Cinacalcet 30mg Tablets for N-nitroso Impurity
Aurobindo Pharma USA is recalling Cinacalcet 30mg tablets nationwide due to N-nitroso Cinacalcet impurity above FDA limits. Patients should contact their healthcare provider about their medication.
Product
Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0076-2025·2024-12-11
Levothyroxine Sodium Tablets Recalled Due to Subpotency Nationwide
Accord Healthcare is recalling Levothyroxine Sodium 75 mcg tablets (Lot D2300191, expiring 12/31/2025) distributed nationwide due to subpotency. Affected patients should contact their healthcare provider.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0107-2025·2024-12-11
Duloxetine DR Capsules recalled nationwide for nitrosamine impurity
Rising Pharmaceuticals is recalling Duloxetine DR Capsules 60 mg nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA interim limits. The recall affects approximately 233,003 bottles.
Product
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0108-2025·2024-12-11
Cinacalcet Tablets Recalled for Excess Nitrosamine Impurity
AvKARE is recalling Cinacalcet Tablets 30 mg due to nitrosamine impurity levels exceeding safe limits. Affected bottles nationwide should not be used.
Product
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0082-2025·2024-12-11
Prescription Drug Recall: Venofer Iron Sucrose Vials with Glass Delamination Risk
American Regent, Inc. is recalling specific lots of Venofer (iron sucrose) injection due to potential glass delamination in vials. The intravenous drug distributed nationwide may contain particulate matter.
Product
VENOFER — VENOFER (IRON SUCROSE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0095-2025·2024-12-11
Diltiazem Hydrochloride Extended-Release Capsules Recalled for Manufacturing Impurity
Glenmark Pharmaceuticals is recalling 25,584 bottles of Diltiazem Hydrochloride Extended-Release Capsules 120 mg nationwide due to a manufacturing impurity above FDA-recommended limits. The affected medication was distributed throughout the United States.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0102-2025·2024-12-11
Prescription drug esomeprazole magnesium recalled for labeling error
Zydus Pharmaceuticals is recalling esomeprazole magnesium oral suspension because of an incorrect NDC number on package labeling. The affected product is lot M408002 distributed nationwide.
Product
ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0092-2025·2024-12-11
Compliance Dishwashing Liquid and Antibacterial Soap recalled for microbial contamination
Midlab Incorporated is recalling Compliance brand dishwashing liquid and antibacterial soap due to microbiological contamination from manufacturing process deviations. The product was distributed nationwide; no illnesses have been reported.
Product
Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal Corporation, 10232 Palm Drive, Santa Fe Springs, CA 90670
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0111-2025·2024-12-11
Pigmentation treatment product recalled for manufacturing process deviations
Only Your Rx pigmentation product is being recalled due to manufacturing quality deviations in water systems used during production. The product was distributed in California only.
Product
10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottle, For Professional Use Only, Only YourRx Inc., Chatsworth, CA 91311, Made in USA, Onlyyourrx.com.
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0088-2025·2024-12-11
Boardwalk Antibacterial Handsoap Refill Recalled for Microbial Specification Failure
Midlab Incorporated is recalling boardwalk Antibacterial Handsoap Refill due to out-of-specification microbial test results. Affected lot 0711241 was distributed nationwide.
Product
boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfield, IL 60015
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0087-2025·2024-12-11
MAXIM Assure Antibacterial Hand Soap Recalled for Microbial Contamination
Midlab Incorporated is recalling MAXIM Assure Antibacterial hand soap (Lot 0711241) nationwide due to out-of-specification microbial test results in the manufacturing process.
Product
MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0063-2025·2024-12-04
Drug recall: Absorbine Jr. Ultra Strength Pain Patch manufacturing deviations
Absorbine Jr. Ultra Strength Pain Patch is being recalled nationwide due to manufacturing process deviations. The voluntary recall affects approximately 4,968,000 patches.
Product
ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 89476 41318 3, UPC 8 89476 41336 7
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0067-2025·2024-12-04
Menthol Patch Recall Due to Manufacturing Quality Deviations
HealthWise Menstrual Pain Relief Patch (Menthol 10%) is recalled due to manufacturing quality deviations. The firm-initiated recall affects 10,368 patches distributed nationwide in the US.
Product
HEALTHWISE MENSTRUAL PAIN RELIEF PATCH — HEALTHWISE MENSTRUAL PAIN RELIEF PATCH (MENTHOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0069-2025·2024-12-04
LILAS Feminine Pain Relief Patch recalled for manufacturing violations
Unexo Life Sciences is voluntarily recalling LILAS Feminine Pain Relief Patch nationwide due to manufacturing practice deviations affecting 363,300 patches.
Product
LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099 48211 4), Distributed by: Lilas Wellness, Inc., Beaverton, Oregon 97008-7105
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0066-2025·2024-12-04
FDA Recalls Menthol Medicated Patches Due to Manufacturing Deviations
FDA recalls THERA CARE COLD HOT MEDICATED PATCH (menthol 5%) due to manufacturing practice deviations. The voluntary recall affects 279,936 patches distributed nationwide.
Product
THERA CARE COLD HOT MEDICATED PATCH — THERA CARE COLD HOT MEDICATED PATCH (MENTHOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0065-2025·2024-12-04
THERACARE Lidocaine Pain Relief Patches Recalled for Manufacturing Deviations
THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH (4% lidocaine) is being recalled nationwide due to manufacturing practice deviations. Unexo Life Sciences, the manufacturer, voluntarily initiated the recall after identifying quality control issues.
Product
THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH — THERACARE MAXIMUM STRENGTH PAIN RELIEF PATCH (LIDOCAINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0072-2025·2024-12-04
Parche Leon pain relief patches recalled for manufacturing deviations
Unexo Life Sciences Private Limited is voluntarily recalling Parche Leon pain relief patches due to manufacturing practice deviations. No illnesses or injuries have been reported.
Product
PARCHE LEON — PARCHE LEON (CAPSAICIN, CAMPHOR, MENTHOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0070-2025·2024-12-04
JR Watkins Menthol Pain Relief Patches Recalled for Manufacturing Deviations
JR Watkins Cooling Pain Relief Patches are being recalled due to manufacturing process deviations identified during production.
Product
JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC 8 56294 00878 5
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0064-2025·2024-12-04
Absorbine Jr Pain Relieving Knee Patch recalled for manufacturing deviations
Unexo Life Sciences is recalling Absorbine Jr Pain Relieving Knee Patch nationwide due to manufacturing process deviations that do not meet FDA standards. No illnesses or injuries have been reported.
Product
ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 patches (UPC 8 89476 41306 0), Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0068-2025·2024-12-04
Equate Maximum Strength Lidocaine Pain Relieving Patches Recalled for Manufacturing Deviations
Equate Maximum Strength Lidocaine Pain Relieving Patches (4%) are being recalled due to current Good Manufacturing Practice deviations. Approximately 1.1 million patches were distributed nationwide in the US.
Product
EQUATE PAIN RELIEVING PATCHES — EQUATE PAIN RELIEVING PATCHES (LIDOCAINE 4%)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0073-2025·2024-12-04
FDA Drug Recall: LICEOUT Liquid Lice Treatment for Manufacturing Violations
Neogen Corporation voluntarily recalled 5,328 sachets of LICEOUT lice treatment due to manufacturing practice violations. The product was distributed to Bob Barker Company for institutional facilities.
Product
LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53427-124-01
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0062-2025·2024-12-04
Topical menthol back patch recalled for manufacturing deviations
ABSORBINE jr. Extra Large Back Patch containing 5% menthol is being recalled nationwide due to manufacturing compliance deviations. The Class II recall affects 6,848,820 patches distributed by Absorbine Jr., LLC.
Product
ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 UPC 8 89476 41218 6, UPC 8 89476 41236 0
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0071-2025·2024-12-04
FDA Recalls Cheeky Bonsai Menthol Pain Relief Patches for Manufacturing Deviations
Cheeky Bonsai Pain Relief Patches (Menthol 10%) are being recalled nationwide due to manufacturing facility compliance deviations. The voluntary recall affects 17,928 patches distributed across the US.
Product
CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0074-2025·2024-12-04
Drug Lice Treatment Recalled Due to Manufacturing Practice Violations
Neogen Corporation has voluntarily recalled LICEOUT liquid lice treatment due to manufacturing practice violations. The recall affects 8,328 jugs distributed to institutions.
Product
LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per jug, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53247-124-02
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0075-2025·2024-12-04
Menthol pain relief patches recalled for manufacturing practice violations
J.R. Watkins is recalling Cooling Menthol Extra Strength Pain Relief Patches nationwide due to manufacturing practice deviations. The recall affects approximately 7,138 patches from lots JC101, JC102, and JC103.
Product
Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05
Category
Drug
Distribution
Distributed nationwide

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1426–1450 of 17964