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

576–600 of 673

SevereFDA (Drugs)·D-0795-2021·2021-09-22
Florance Morris Hand Sanitizer Recalled for Methanol Contamination
Florance Morris ANTISEPTIC Hand Sanitizer (70% ethyl alcohol) distributed nationwide is recalled due to FDA-detected methanol contamination and insufficient ethanol content. The product was distributed by Asimex International LLC in Florida.
Product
Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0800-2021·2021-09-22
Lidocaine Hydrochloride Topical Solution Recalled for Superpotency
Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution, USP 4% due to the product being superpotent. The recall affects 32,544 bottles distributed nationwide in the United States and Canada.
Product
Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0803-2021·2021-09-22
MIC+Methyl B12 Injection Recalled for Lack of Processing Controls
Promise Pharmacy is recalling MIC+Methyl B12 injection (57 vials, Lot# 06152021@2) distributed across five states due to lack of processing controls that may affect product quality and safety.
Product
MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only, Promise Pharmacy 31818 US Hwy 19N Palm Harbor FL 34684 1-888-3PROMIS
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-0805-2021·2021-09-22
AMINOSYN II 15% Amino Acid Injection Recalled for Particulate Matter
ICU Medical Inc is recalling AMINOSYN II 15% An Amino Acid Injection due to the presence of particulate matter including fibers, hair, and proteinaceous material found in retained samples.
Product
AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7171-17
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0779-2021·2021-09-08
MEDICALLY MINDED Hand Sanitizer Gel Recalled for Methanol Contamination
Global Sanitizers LLC is recalling MEDICALLY MINDED Hand Sanitizer Gel (8.5 FL OZ) due to potential methanol contamination. The product was manufactured under the same conditions as a lot previously found to contain methanol.
Product
MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ (250 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Ma
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0781-2021·2021-09-08
Hand Sanitizer Gel Recalled for Methanol Contamination and Low Ethanol
MEDICALLY MINDED Hand Sanitizer Gel (Ethyl Alcohol 70%) distributed nationwide has been recalled after FDA testing found methanol contamination and ethanol content below label claims. Consumers should stop using the product.
Product
MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0782-2021·2021-09-08
MEDICALLY MINDED Hand Sanitizer Gel Recalled for Methanol Contamination
Global Sanitizers LLC is recalling MEDICALLY MINDED Hand Sanitizer Gel (Ethyl Alcohol 70% v/v, 8.5 FL OZ / 250 mL) distributed nationwide due to manufacturing conditions that led to methanol contamination in product lots.
Product
MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1 ,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0783-2021·2021-09-08
MEDICALLY MINDED Hand Sanitizer Gel Recalled for Manufacturing Deviations
Global Sanitizers LLC is recalling MEDICALLY MINDED Hand Sanitizer Gel (70% ethyl alcohol, 8 fl oz bottles) distributed nationwide due to manufacturing deviations under conditions that produced a methanol-contaminated product lot.
Product
MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 Fl OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200. Distributed by SBL Brands, LLC Las Vegas, NV 89119 UPC: 6
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0780-2021·2021-09-08
MEDICALLY MINDED Hand Sanitizer Gel recalled for methanol contamination
The FDA found one lot of MEDICALLY MINDED Hand Sanitizer Gel to contain methanol and fall below the labeled ethanol content. The product was distributed nationwide.
Product
MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 FL OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made i
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0778-2021·2021-09-08
Hand Sanitizer Gel Recalled Due to Methanol Contamination Risk
Global Sanitizers LLC is recalling MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel (70% ethyl alcohol) due to manufacturing deviations. Products were made under the same conditions as a lot found to contain methanol.
Product
MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactured by Grupo V-Klean S.A. de C.V, Calle Alborada 124, Parques del Pedregal, Tlalpan, 14250 Ciudad de Mexico, CDMX, Distributed by SBL Brands, LLC. Las Vegas, NV
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0765-2021·2021-09-01
Fludarabine Phosphate Injection Recalled Due to Sterility Concern
Custopharm, Inc. is recalling Fludarabine Phosphate for Injection, USP 50 mg because the manufacturer detected microbial contamination during environmental monitoring in aseptic manufacturing areas, raising sterility assurance concerns.
Product
FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0767-2021·2021-09-01
SterRx Sodium Bicarbonate Injection Recalled for Non-Sterility
SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection due to microbial contamination confirmed by third-party laboratory testing. The affected product is a prescription intravenous injection distributed nationwide.
Product
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0768-2021·2021-09-01
SterRx Sodium Bicarbonate in 5% Dextrose Injection Recalled for Sterility Concerns
SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection (1,000 mL bags) nationwide due to lack of assurance of sterility. Patients using affected lots should consult their healthcare provider immediately.
Product
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0773-2021·2021-09-01
Trulicity autoinjector pens recalled for incorrect strength labeling
Eli Lilly & Company is recalling Trulicity (dulaglutide) 0.75 mg autoinjector pens because some contain double the labeled strength. Affected patients may receive an incorrect dose.
Product
TRULICITY — TRULICITY (DULAGLUTIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0770-2021·2021-09-01
Miss Slim capsules recalled for unapproved marketing distribution
HIS ENTERPRISE INC is recalling all lots of Miss Slim capsules (10-count and 30-count boxes) distributed nationwide in the USA because the product was marketed without required FDA approval (ANDA/NDA).
Product
Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0772-2021·2021-09-01
Atovaquone Oral Suspension Recalled for Temperature Abuse
KVK-Tech, Inc. is recalling Atovaquone Oral Suspension due to temperature abuse that caused unusual grittiness in the product. The defect may affect the medication's quality and safety.
Product
ATOVAQUONE ORAL SUSPENSION — ATOVAQUONE ORAL SUSPENSION (ATOVAQUONE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0737-2021·2021-08-25
Leucovorin Calcium Injection Recalled Due to Sterility Concerns
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product meets sterility standards.
Product
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0738-2021·2021-08-25
Teva Epoprostenol Sodium for Injection Recalled for Sterility Assurance
Teva Pharmaceuticals USA is recalling Epoprostenol Sodium for Injection (1.5 mg/vial, 10 mL vials) due to lack of assurance of sterility. The affected lot was distributed nationwide.
Product
Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0741-2021·2021-08-25
Metoclopramide Injection Vials Recalled for Lack of Sterility Assurance
Teva Pharmaceuticals USA is recalling 25,653 vials of Metoclopramide Injection USP due to lack of assurance of sterility. The affected vials were distributed nationwide, including Puerto Rico.
Product
METOCLOPRAMIDE — METOCLOPRAMIDE (METOCLOPRAMIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0739-2021·2021-08-25
Teva Norepinephrine Bitartrate Injection Recalled for Sterility Assurance
Teva Pharmaceuticals USA is recalling Norepinephrine Bitartrate Injection, USP 4 mg/4 mL vials due to lack of assurance of sterility. The product was distributed nationwide.
Product
Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0747-2021·2021-08-25
Leucovorin Calcium for Injection recalled for lack of sterility assurance
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product is sterile. Patients using recalled lot should consult their healthcare provider.
Product
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0732-2021·2021-08-25
Haloperidol Decanoate Injection recalled due to sterility concerns
Teva Pharmaceuticals USA is recalling Haloperidol Decanoate Injection 100 mg/mL due to lack of assurance of sterility. The recall affects 16,226 vials distributed nationwide, including Puerto Rico.
Product
Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0746-2021·2021-08-25
Leucovorin Calcium for Injection Recalled Due to Sterility Assurance Concerns
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection in 100 mg/vial 10 mL single-use vials due to lack of assurance of sterility. The recall affects approximately 476,275 vials distributed nationwide, including Puerto Rico.
Product
Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0748-2021·2021-08-25
Adenosine Injection Recalled for Lack of Sterility Assurance
Teva Pharmaceuticals USA is recalling Adenosine Injection (60 mg/20 mL vials) nationwide due to lack of assurance of sterility, which could pose a serious health risk if the product is not sterile.
Product
Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0734-2021·2021-08-25
Idarubicin Hydrochloride Injection Recalled Due to Sterility Concerns
Teva Pharmaceuticals USA is recalling Idarubicin Hydrochloride Injection 20 mg/20 mL vials nationwide due to lack of assurance of sterility. The recall affects 2,091 vials distributed across the United States and Puerto Rico.
Product
Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11
Category
Drug
Distribution
Distributed nationwide

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576–600 of 673