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

901–925 of 11803

HighFDA (Drugs)·D-0665-2024·2024-10-02
Refresh LACRI-LUBE Eye Ointment Recalled for Potential Tube Seal Breach
Allergen is recalling specific lots of Refresh LACRI-LUBE eye ointment (763,426 tubes) due to potential breaches in the tube seal that may compromise sterility. Consumers should verify their product lot number against the recall list.
Product
Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0663-2024·2024-10-02
Pyridoxine Injection Solution Recalled Due to Lack of Sterility Assurance
Empower Pharmacy is recalling a pyridoxine (B6) injection solution because sterility assurance could not be confirmed. The recalled product is lot 609763 with a beyond-use date of 04/18/2025.
Product
Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0657-2024·2024-09-18
Barrier Therapy Skin Protectant Cream recalled for microbial contamination
Prequel Skin is recalling Barrier Therapy Skin Protectant Cream due to microbial contamination. The recall affects approximately 30,946 tubes distributed nationwide and online.
Product
BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8 10129 11007 4
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0649-2024·2024-09-11
FDA Recalls Heparin Sodium Injection for Endotoxin Contamination
Baxter Healthcare Corporation is recalling 44,208 containers of Heparin Sodium in Sodium Chloride Injection nationwide after endotoxin testing revealed out-of-limit results. The contamination poses a risk of serious adverse reactions in patients receiving the intravenous medication.
Product
HEPARIN SODIUM IN SODIUM CHLORIDE — HEPARIN SODIUM IN SODIUM CHLORIDE (HEPARIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0653-2024·2024-09-11
Compounded Semaglutide Recalled Due to Lack of Sterility Assurance
ProRx LLC is recalling 1,960 vials of compounded semaglutide nationwide due to lack of assurance of sterility. The multiple-dose vials may not meet sterility standards for injectable medications.
Product
SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0656-2024·2024-09-11
Tirzepatide Injectable Drug Recalled for Sterility Assurance Defect
ProRx LLC is recalling 1,732 vials of Tirzepatide 60 mg/3mL nationwide due to lack of assurance of sterility. Affected lots have beyond-use dates of 11/21/2024 and 12/09/2024.
Product
TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0654-2024·2024-09-11
ProRx Compounded Semaglutide/Cyanocobalamin Injection Recalled Due to Sterility Assurance Issues
ProRx LLC is recalling 500 vials of compounded Semaglutide/Cyanocobalamin Injection (Lot #ProRx031924-1) distributed nationwide in the United States due to lack of sterility assurance. The beyond-use date is 09/18/2024.
Product
Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0650-2024·2024-09-11
Compounded semaglutide injection recalled due to sterility concerns
ProRx LLC is recalling compounded semaglutide injections due to lack of assurance of sterility. The recall affects 2,490 vials distributed nationwide.
Product
Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0655-2024·2024-09-11
Tirzepatide Injectable Vials Recalled for Sterility Assurance
ProRx LLC is recalling Tirzepatide 20 mg/2mL injectable vials nationwide due to lack of assurance of sterility. Patients who received vials from lot ProRx051424 should contact their healthcare provider.
Product
TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0651-2024·2024-09-11
Compounded Tirzepatide Injectable Vials Recalled for Sterility Assurance Issues
ProRx LLC is recalling 37 vials of compounded Tirzepatide injectable due to lack of sterility assurance. The 2 mL vials (10 mg/mL and 20 mg/mL) were distributed nationwide.
Product
Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0652-2024·2024-09-11
Compounded Semaglutide Injection Vials Recalled for Sterility Concerns
ProRx LLC is recalling approximately 8,396 vials of compounded semaglutide due to lack of assurance of sterility. The medication was distributed nationwide.
Product
SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0647-2024·2024-09-04
Ibuprofen Tablets Recalled Due to Failed Impurities and Degradation Specifications
Preferred Pharmaceuticals is recalling 266 bottles of generic ibuprofen tablets due to failed impurities and degradation specifications discovered during stability testing. The affected lots were distributed in California and Nevada.
Product
Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0646-2024·2024-09-04
Prescription Ibuprofen Tablets Recalled for Excessive Unknown Impurities
Dr. Reddy's Laboratories is recalling IBU Ibuprofen 400 mg prescription tablets due to impurity levels exceeding specifications. The recall affects 14,940 bottles distributed nationwide in the USA and Puerto Rico.
Product
IBU — IBU (IBUPROFEN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0645-2024·2024-09-04
IBU Prescription Ibuprofen Tablets Recalled for Failed Impurity Specifications
Dr. Reddy's Laboratories is recalling 31,802 bottles of IBU Ibuprofen 600mg tablets due to failed impurity specifications. The product was distributed nationwide and in Puerto Rico.
Product
IBU — IBU (IBUPROFEN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0644-2024·2024-09-04
Prescription Ibuprofen Recalled Due to Failed Impurity Specifications
Dr. Reddy's Laboratories is recalling IBU (Ibuprofen) 800 mg prescription tablets nationwide due to failed quality specifications. Testing found unknown impurities exceeding acceptable limits.
Product
IBU — IBU (IBUPROFEN)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0641-2024·2024-08-28
Acetaminophen Aspirin Caffeine Tablets Recalled for Missing Drug Facts Labels
Aurohealth LLC is recalling Acetaminophen, Aspirin and Caffeine tablets because some bottles are missing the manufacturer's label containing drug facts information. Affected product was distributed in NJ, NY, and PA.
Product
ACETAMINOPHEN ASPIRIN AND CAFFEINE — ACETAMINOPHEN ASPIRIN AND CAFFEINE (ACETAMINOPHEN, ASPIRIN AND CAFFEINE)
Category
Drug
Distribution
3 states
SevereFDA (Drugs)·D-0638-2024·2024-08-28
FDA Class I Recall: B. Braun Sodium Chloride Injection for Particulate Matter
B. Braun Medical Inc. is recalling 63,444 containers of 0.9% Sodium Chloride Injection USP nationwide due to the presence of particulate matter. This intravenous medication may pose a serious health risk if administered to patients.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0635-2024·2024-08-28
FDA Recalls Acetaminophen Injection Due to Labeling Mix-up
Hikma Pharmaceuticals is recalling Acetaminophen Injection because bags of Dexmedetomidine HCl were found packaged inside Acetaminophen-labeled overWraps. The error could result in patients receiving the wrong intravenous medication.
Product
ACETAMINOPHEN — ACETAMINOPHEN (ACETAMINOPHEN)
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0636-2024·2024-08-28
Lidocaine HCl Injection Recall Due to Lack of Sterility Assurance
Fagron Compounding Services is recalling Lidocaine HCl Injection due to lack of assurance of sterility. Four lot numbers distributed nationwide are affected with expiration date 10/14/2024.
Product
Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0637-2024·2024-08-28
Testosterone Gel Recalled by Teva for Excessive Potency
Teva Pharmaceuticals recalls 7,080 packets of Testosterone Gel nationwide due to higher-than-labeled potency. Patients using the recalled product may receive unintended overdoses.
Product
TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0639-2024·2024-08-28
Rubbing Alcohol Recalled for Non-Sterile Water in Manufacturing
ZEE Company's 70% isopropyl rubbing alcohol is being recalled because non-sterile water was used in production instead of sterile water, violating manufacturing standards. The product was distributed nationwide in the US and Canada.
Product
Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401 Cummings Road, Chattanooga, TN 37419, Made in USA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0632-2024·2024-08-21
Ophthalmic solution recalled for defective container with lodged spike
FDC Limited recalls Timolol Maleate eye drops (362,544 bottles) nationwide due to a manufacturing defect: a yellow spike from the cap lodged in the nozzle, posing a risk of eye injury.
Product
TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0626-2024·2024-08-14
Dietary supplement tainted with undeclared pharmaceuticals recalled nationwide
Umary Acido Hialuronico dietary supplement (850 mg caplets) was recalled nationwide by the FDA for containing undeclared Diclofenac and Omeprazole. The product was marketed without an approved drug application.
Product
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0631-2024·2024-08-14
Acetaminophen tablets incorrectly labeled with aspirin drug facts information
Some bottles of Acetaminophen Extra Strength 500 mg tablets are labeled with the drug facts information for Aspirin 81 mg tablets. The affected lot is 4138197 (expiration 10/31/2025), distributed nationwide.
Product
ACETAMINOPHEN — ACETAMINOPHEN (ACETAMINOPHEN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0634-2024·2024-08-14
Gabapentin 600 mg Tablets Recalled Due to Metformin Contamination
Granules Pharmaceuticals Inc. is recalling Gabapentin Tablets 600 mg nationwide after fused Metformin ER tablets were found in bottles, creating a risk of unintended medication exposure.
Product
GABAPENTIN — GABAPENTIN (GABAPENTIN)
Category
Drug
Distribution
Distributed nationwide

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901–925 of 11803