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

376–400 of 673

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-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-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-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-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-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-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-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
SevereFDA (Drugs)·D-0321-2022·2022-01-05
SterRx Norepinephrine 8 mg Sodium Chloride Injection Recalled
SterRx, LLC is recalling 74,508 bags of Norepinephrine 8 mg per 250 mL in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.
Product
NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-676-01.
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-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-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-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
0 states
SevereFDA (Drugs)·D-0316-2022·2022-01-05
SterRx Fentanyl Citrate Injection Recalled for Sterility Assurance Failure
SterRx is recalling fentanyl citrate injection nationwide due to lack of assurance of sterility. The recall affects approximately 10,660 bags of the product.
Product
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-01.
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-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-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-0303-2022·2022-01-05
SterRx Norepinephrine Injection Recalled Due to Sterility Assurance Concerns
SterRx is recalling 9,360 bags of Norepinephrine 4 mg per 250 mL injection nationwide due to lack of assurance of sterility. The product is used in hospital and clinical settings to treat low blood pressure.
Product
NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-451-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0320-2022·2022-01-05
SterRx Norepinephrine Injection Recalled Due to Lack of Sterility Assurance
SterRx is recalling 121,584 bags of Norepinephrine 4 mg per 250 mL injection nationwide due to lack of assurance of sterility. The drug is used to treat low blood pressure in critical care settings.
Product
NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-651-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0293-2022·2021-12-29
OTC Cough and Cold Drug Recalled for Microbial Contamination
Efficient Laboratories is recalling approximately 4,026 bottles of Rompe Pecho Max Multi-Symptoms cough and cold medicine nationwide due to potential microbial contamination of the non-sterile product.
Product
ROMPE PECHO MAX MULTI SYMPTOMS — ROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0288-2022·2021-12-29
Moxifloxacin 1 mg/mL Solution Label Mix-up Recall
Denver Solutions, LLC (doing business as Leiters Health) is recalling Moxifloxacin 1 mg/mL intracameral injection solution because vials labeled as 1 mg/mL may actually contain 5 mg/mL, creating a serious dosing error risk.
Product
Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0292-2022·2021-12-29
OTC Expectorant Recall: Microbial Contamination in Rompe Pecho
Efficient Laboratories is recalling Rompe Pecho guaifenesin expectorant in 4 fl oz and 6 fl oz bottles due to microbial contamination of non-sterile products. The affected product was distributed nationwide.
Product
ROMPE PECHO — ROMPE PECHO (GUAIFENESIN)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0280-2022·2021-12-22
Lidocaine Topical Solution Recalled for Superpotency
Teligent Pharma, Inc. is recalling Lidocaine Hydrochloride Topical Solution USP 4% nationwide due to the drug being superpotent. Affected lots are 13262 (Exp. 03/2022) and 14217 (Exp. 08/2022).
Product
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0266-2022·2021-12-15
AmericanScreening Hand Sanitizer Recalled for Misleading Bottle Resemblance
AmericanScreening Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ bottles, is being recalled nationwide because the containers resemble drinking water bottles, posing a risk of accidental ingestion.
Product
AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ (237 mL) bottle with either a black or clear top, Distributed by American Screening LLC Shreveport, LA, 71106 UPC 8 40050 51579 2
Category
Drug
Distribution
Distributed nationwide

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