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

4651–4675 of 18005

ModerateFDA (Drugs)·D-0340-2022·2022-01-12
H.E.B Allergy Relief Fexofenadine Tablets Recalled for Failed Impurity Specifications
H.E.B Allergy Relief fexofenadine hydrochloride tablets (180mg) are being recalled nationwide due to out-of-specification results for impurity A found during stability testing. The affected product is available in 15, 30, and 45 count bottles.
Product
H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihistamine packaged as a) 15 count bottle, NDC 37808-571-22, UPC 0 41220 53081 6; b) 30 count bottle, NDC 37808-571-39, UPC 0 41220 53082 3; c) 45 count bottle, NDC 37808-571-95, UPC 0 41220 53083 0; Ma
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0358-2022·2022-01-12
Oxycodone Hydrochloride Tablets Recalled for Out-of-Specification Impurity
Lupin Pharmaceuticals is recalling Oxycodone Hydrochloride Tablets (5 mg) due to out-of-specification impurity test results detected during long-term stability testing. Affected units were distributed in New York and Ohio.
Product
OXYCODONE HYDROCHLORIDE — OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0339-2022·2022-01-12
H.E.B Allergy Relief Fexofenadine tablets recalled for impurity specification failure
Perrigo Company is recalling H.E.B Allergy Relief fexofenadine hydrochloride 60mg tablets nationwide due to failure of impurity specifications during stability testing.
Product
H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0353-2022·2022-01-12
Wal-Fex Fexofenadine Tablets Recalled for Impurity Specifications
Perrigo Company is recalling Wal-Fex Fexofenadine Hydrochloride 60mg tablets due to out-of-specification impurity levels detected during stability testing. The recall affects 4,536 containers distributed nationwide.
Product
Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle, Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic, NDC 0363-0903-62 UPC 3 11917 18625 2
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0345-2022·2022-01-12
Perrigo Fexofenadine Hydrochloride 180mg tablets recalled for impurity
Perrigo Company PLC is recalling Fexofenadine Hydrochloride 180mg antihistamine tablets due to an out-of-specification impurity result detected during stability testing. The recall affects approximately 89,664 containers distributed nationwide.
Product
Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-571-78 UPC 3 45802 571 78 6
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0363-2022·2022-01-05
kleantouch Hand Sanitizer recalled for methanol contamination
Valisa MFG LLC is recalling kleantouch Hand Sanitizer 8 FL OZ pump bottles nationwide because the product contains methanol and was marketed without FDA approval. Consumers should stop using the product immediately.
Product
kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735, Made in USA, UPC 6 86162 99246 1
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0315-2022·2022-01-05
dilTIAZem HCl in Dextrose Injection Recalled for Sterility Assurance
SterRx is recalling dilTIAZem HCl in 5% Dextrose Injection due to lack of assurance of sterility. The recall affects 8,946 bags distributed nationwide.
Product
dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0301-2022·2022-01-05
SterRx Morphine Sulfate Injection Recalled for Sterility Assurance
SterRx is recalling Morphine Sulfate in 0.9% Sodium Chloride Injection (1 mg per mL) nationwide due to lack of assurance of sterility. The recall affects 880 units distributed across the United States.
Product
Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY, 12903, NDC 70324-427-02.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0300-2022·2022-01-05
SterRx Midazolam Injection Recalled for Lack of Sterility Assurance
SterRx, LLC is recalling Midazolam in 0.9% Sodium Chloride Injection (50 mg per 50 mL) distributed nationwide due to lack of assurance of sterility. The recall affects 15,660 bags from seven lots manufactured between November and December 2021.
Product
Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #70324-102-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0298-2022·2022-01-05
Klean Touch Hand Sanitizer Recalled: Unapproved Methanol-Containing Drug
Aroma Release Technologies Inc is recalling Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) in 55-gallon drums because the product contains methanol and was marketed without FDA approval as a new drug.
Product
Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Technology, Inc., 7026 Discovery Drive, Chattanooga, TN 37416
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0299-2022·2022-01-05
Veklury (Remdesivir) Drug Vials Recalled for Glass Particulate Matter
Gilead Sciences is recalling Veklury (remdesivir) injection vials nationwide due to the presence of glass particulates detected during a customer complaint investigation. The affected lots are 2141001-1A and 2141002-1A with expiration date 01/2024.
Product
VEKLURY — VEKLURY (REMDESIVIR)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0306-2022·2022-01-05
Sodium Bicarbonate in 5% Dextrose Injection Recalled for Sterility Assurance
SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The recall affects 127,260 bags distributed across the U.S.
Product
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0305-2022·2022-01-05
Phenylephrine HCL Injection Recalled for Lack of Sterility Assurance
SterRx is recalling approximately 18,948 bags of Phenylephrine HCL in 0.9% Sodium Chloride injection nationwide due to lack of assurance of sterility. The product is distributed across the U.S.A.
Product
PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-701-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0308-2022·2022-01-05
SterRx Epinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling epinephrine in 0.9% sodium chloride injection (4 mg per 250 mL) nationwide due to lack of assurance of sterility. The recall affects 26,928 bags distributed across the United States.
Product
EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-227-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0310-2022·2022-01-05
Epinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling epinephrine injection (8 mg per 250 mL) due to lack of assurance of sterility. The recall affects 5,832 bags distributed nationwide.
Product
EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-077-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0295-2022·2022-01-05
Lidocaine Hydrochloride Topical Solution recalled for being superpotent
Teligent Pharma has recalled 6,816 bottles of Lidocaine Hydrochloride Topical Solution 4% nationwide due to the drug being superpotent. The recall is voluntary and involves Lot #16345 with expiration date 01/2024.
Product
LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0311-2022·2022-01-05
SterRx Epinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling 684 bags of epinephrine in 0.9% sodium chloride injection nationwide due to lack of assurance of sterility. The product is supplied to hospitals and healthcare facilities.
Product
EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-627-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0312-2022·2022-01-05
Midazolam Injection Recalled Due to Lack of Sterility Assurance
SterRx is recalling Midazolam in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The recall affects approximately 36,360 bags distributed across the United States.
Product
Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-102-02.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0304-2022·2022-01-05
EPINEPHrine Injection Recall Due to Lack of Sterility Assurance
SterRx is recalling EPINEPHrine 2 mg per 250 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects 2,779 bags distributed across the U.S.
Product
EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-027-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0309-2022·2022-01-05
Epinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling epinephrine in 0.9% sodium chloride injection (5 mg per 250 mL) nationwide due to lack of assurance of sterility. Affected lots are identified by codes S21255/BXA, S21264/BXH, and S21328/BZO.
Product
EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-052-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0318-2022·2022-01-05
SterRx Morphine Sulfate Injection Recalled for Sterility Assurance
SterRx is recalling 880 bags of Morphine Sulfate in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. Patients and healthcare providers should stop using affected units immediately.
Product
MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-427-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0323-2022·2022-01-05
SterRx Phenylephrine HCl Injection Recalled for Sterility Assurance
SterRx is recalling PHENYLephrine HCl 40 mg per 250 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects approximately 20,640 bags distributed across the United States.
Product
PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0319-2022·2022-01-05
SterRx Norepinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling 1,044 bags of Norepinephrine 16 mg per 250 mL in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The affected product carries NDC 70324-002-01 with lot code S21194/CDW.
Product
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-002-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0325-2022·2022-01-05
Sodium Bicarbonate in 5% Dextrose Injection Lacks Sterility Assurance
SterRx is recalling 2,886 bags of Sodium Bicarbonate in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The affected product may pose a risk to patients who receive this intravenous medication.
Product
Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0314-2022·2022-01-05
SterRx Norepinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling 1,428 bags of Norepinephrine in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The product is a prescription injectable medication.
Product
NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-476-01.
Category
Drug
Distribution
Distributed nationwide

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4651–4675 of 18005