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

1401–1425 of 17762

HighFDA (Drugs)·D-0101-2025·2024-12-11
Duloxetine Capsules recalled for manufacturing impurity exceeding FDA interim limit
Amerisource Health Services LLC is recalling 8,561 bottles of Duloxetine Delayed-Release Capsules, 60 mg due to N-nitroso-duloxetine impurity above recommended interim limits. The affected lots were distributed in Pennsylvania, Ohio, and Puerto Rico.
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
Category
Drug
Distribution
3 states
HighFDA (Drugs)·D-0106-2025·2024-12-11
Duloxetine Delayed-Release Capsules Recalled for N-Nitroso Impurity Above Limits
Rising Pharma is recalling 122,925 bottles of Duloxetine 30 mg capsules nationwide due to a manufacturing deviation: the presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Product
Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0103-2025·2024-12-11
Prescription Drug Sunitinib Malate Subject to Label Mix-Up Recall
AvKARE is recalling 40 bottles of Sunitinib Malate Capsules due to a label mix-up. The affected lot was distributed nationwide in the United States.
Product
SUNITINIB MALATE — SUNITINIB MALATE (SUNITINIB MALATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0097-2025·2024-12-11
Diltiazem extended-release capsules recalled for manufacturing impurity
Glenmark Pharmaceuticals is recalling 4,704 bottles of Diltiazem Hydrochloride extended-release capsules 90mg due to manufacturing contamination with an impurity above FDA limits. Two lot numbers distributed nationwide are affected.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0100-2025·2024-12-11
Duloxetine Delayed-Release Capsules Recalled Due to N-nitroso Impurity
Amerisource Health Services is recalling specific lots of Duloxetine 30 mg capsules due to N-nitroso-duloxetine impurity levels exceeding FDA recommendations. Patients taking affected lots should contact their healthcare provider immediately.
Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
Category
Drug
Distribution
3 states
HighFDA (Drugs)·D-0093-2025·2024-12-11
Diltiazem Hydrochloride Capsules Recalled Due to Manufacturing Impurity
Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride Extended-Release Capsules (60 mg) due to presence of N-nitroso-Desmethyl-Diltiazem impurity exceeding FDA limits. Approximately 34,848 bottles nationwide are affected.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0094-2025·2024-12-11
Diltiazem Hydrochloride Capsules Recalled Due to N-Nitroso Impurity Above Limits
Glenmark Pharmaceuticals recalls Diltiazem Hydrochloride extended-release capsules due to presence of N-nitroso-desmethyl-diltiazem impurity above FDA recommended limits. The recall affects 12,864 bottles distributed nationwide.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0078-2025·2024-12-11
Prescription Cinacalcet Tablets Recalled for N-Nitroso Impurity
Aurobindo Pharma USA Inc is recalling Cinacalcet 60mg tablets nationwide due to N-nitroso Cinacalcet impurity exceeding FDA recommended interim limits.
Product
Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), 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-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-0104-2025·2024-12-11
Sunitinib Malate Capsules Recalled Due to Label Mix-Up
AvKARE is recalling Sunitinib Malate 25 mg capsules nationwide due to a label mix-up in lot 100049501. The FDA has classified this as a Class II recall.
Product
SUNITINIB MALATE — SUNITINIB MALATE (SUNITINIB MALATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0080-2025·2024-12-11
Venofer Iron Sucrose Injection Recalled for Potential Glass Contamination
American Regent is recalling specific lots of Venofer (iron sucrose) injection due to potential glass delamination from vials. The affected drug is distributed nationwide.
Product
VENOFER — VENOFER (IRON SUCROSE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0091-2025·2024-12-11
Genuine Joe Antibacterial Lotion Soap recalled for manufacturing quality issue
Midlab Incorporated is recalling Genuine Joe Antibacterial Lotion Soap (Lot 0711241) nationwide due to out-of-specification microbial test results found during manufacturing quality checks.
Product
Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, GA 30339
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
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-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-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-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
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
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-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-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-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-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-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-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

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1401–1425 of 17762