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

3201–3225 of 11852

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-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
HighFDA (Drugs)·D-0790-2021·2021-09-08
Topical Pain Relief AULIEF Recalled for Facility Contamination Risk
China Gel Inc is recalling AULIEF topical pain relief (menthol and camphor) because the product was manufactured in a facility where Burkholderia cepacia contamination was found in other products.
Product
AULIEF — AULIEF (MENTHOL AND CAMOHOR)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0789-2021·2021-09-08
China-Gel Topical Pain Reliever Recalled for Manufacturing Facility Contamination
China-Gel Inc is recalling China-Gel White topical pain reliever products due to potential contamination with Burkholderia cepacia found at the manufacturing facility. The recall affects multiple package sizes distributed nationwide and internationally.
Product
CHINA-GEL — CHINA-GEL (MENTHOL AND CAMOHOR (SYNTHETIC))
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0788-2021·2021-09-08
China-Gel Topical Pain Reliever Recall Due to Manufacturing Contamination
China Gel Inc is recalling China-Gel (menthol and camphor) topical pain reliever products due to contamination with B. cepacia found in the manufacturing facility where the product was made.
Product
CHINA-GEL — CHINA-GEL (MENTHOL AND CAMOHOR (SYNTHETIC))
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0786-2021·2021-09-08
Akorn Artificial Tears Ointment Recalled for Non-Sterility
Akorn, Inc. is recalling Artificial Tears Ointment eye lubricant due to failure of sterility testing. The product may be contaminated with Bacillus cereus.
Product
Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0776-2021·2021-09-08
Cyclobenzaprine Hydrochloride Tablets 7.5mg Recalled for Microbial Contamination
Teva Pharmaceuticals USA is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg (4,992 bottles, batch 1408824A, expiration 08/2023) distributed nationwide due to out-of-specification microbial test results in an excipient ingredient.
Product
Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01
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-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-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-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-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-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
HighFDA (Drugs)·D-0755-2021·2021-09-01
Pi yen chin Ophthalmic Redness Reliever Drops recalled due to sterility concerns
Pi yen chin Ophthalmic Redness Reliever Drops are being recalled because they are actually manufactured as nasal drops and sterility cannot be assured. The product is labeled for ophthalmic use but does not meet the safety standards required for eye application.
Product
Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Chinese writing)International Nature Nutraceuticals, Inc. New York, NY 10002 www.INNHERB.com. Konzon NDC 51367-008-10
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0754-2021·2021-09-01
Carvedilol 25 mg Tablets Recalled Due to Foreign Medication Contamination
RemedyRepack Inc. is recalling Carvedilol 25 mg tablets after discovering that a 500-count source bottle contained two Paroxetine tablets (40 mg), which were then repackaged into 180-count bottles distributed to medical facilities in Virginia and Florida.
Product
Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01
Category
Drug
Distribution
2 states
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-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-0731-2021·2021-08-25
Methylprednisolone Acetate Injectable Suspension Recall: Sterility Assurance
Teva Pharmaceuticals USA is recalling Methylprednisolone Acetate Injectable Suspension USP 40 mg/mL in single-dose and multi-dose vials nationwide due to lack of assurance of sterility.
Product
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
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-0742-2021·2021-08-25
Teva Alprostadil Injection Recalled for Lack of Sterility Assurance
Teva Pharmaceuticals USA is recalling one lot of Alprostadil Injection USP due to lack of assurance of sterility. The affected product was distributed nationwide, including Puerto Rico.
Product
Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0733-2021·2021-08-25
Amikacin Sulfate Injection Recalled Due to Sterility Assurance Failure
Teva Pharmaceuticals USA is recalling Amikacin Sulfate Injection USP 1 gram/4mL vials nationwide due to lack of assurance of sterility. The recall affects 4,712 vials with lot #31329243B and expiration date 05/2022.
Product
Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01
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-0735-2021·2021-08-25
Teva Vecuronium Bromide Injection Recalled for Sterility Assurance
Teva Pharmaceuticals USA is recalling Vecuronium Bromide for Injection 10 mg vials nationwide due to lack of assurance of sterility. The recall affects 62,358 vials distributed across multiple lots.
Product
Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01
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

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3201–3225 of 11852