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

3601–3625 of 11819

SevereFDA (Drugs)·D-1563-2020·2020-09-16
Open Book Extracts Recalls Hand Sanitizer Labeled With Methanol
Open Book Extracts is recalling Always Be Clean Hand Sanitizer because it is labeled to contain methanol. The recall covers 340,000 packs distributed nationwide.
Product
Always Be Clean Hand Sanitizer (73% Alcohol) 0.04 FL OZ (1.2 mL) packaged in a) Single snaps (NDC 75091-2020-1 UPC 375091202016); b) 100-count boxes (NDC 75091-2020-2 UPC 375091202023); c) 25-count boxes (NDC 75091-2020-3 UPC 375091202030)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1565-2020·2020-09-16
Shine & Clean Hand Sanitizer Recalled for Methanol and Low Ethanol
Maquiladora Miniara S.A. de C.V. is recalling Shine & Clean Hand Sanitizer gel because FDA testing found undeclared methanol and ethanol levels below the label claim.
Product
Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara S.A. de C.V. Carrerera Teoloyucan Huehuetoca km: 22 S/N La Planada Mexico C.P.: 54665 NDC 76753-001-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1564-2020·2020-09-16
Just Hand Sanitizer Recalled for Methanol Labeling Error
Open Book Extracts is recalling Just Hand Sanitizer because it was labeled to contain methanol.
Product
Just Hand Sanitizer (Ethyl Alcohol 73%) Single Use-Packs 100-count NDC 78065-2020-2 UPC 703123998598 (Single packs NDC 78065-2020-1 UPC 703123998659) Distributed by: Just Hand Sanitizer
Category
Drug
Distribution
Distributed nationwide
HighCPSC·20780·2020-09-11
Medique Recalls 31 Over-the-Counter Drugs for Non-Child-Resistant Packaging
Medique is recalling 31 over-the-counter drugs sold on Amazon.com because the packaging is not child-resistant, posing a risk of poisoning to young children.
Product
31 Medique Over-the-Counter drugs from the product lines Medi-First, Medi-First Plus, Medique, Dover, Otis Clapp, and Ecolab
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1576-2020·2020-09-09
Mylan Recalls Tranexamic Acid Injection Due to Labeling Mix-Up
Mylan Institutional LLC is recalling 1,407 cartons of Tranexamic Acid Injection due to a labeling error that may result in the wrong medication being dispensed.
Product
TRANEXAMIC ACID — TRANEXAMIC ACID (TRANEXAMIC ACID)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1575-2020·2020-09-09
Mylan Recalls Amiodarone Hydrochloride Injection Due to Labeling Mix-Up
Mylan Institutional LLC is recalling Amiodarone Hydrochloride Injection due to a labeling error where cartons may contain the wrong medication.
Product
AMIODARONE HYDROCHLORIDE — AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1574-2020·2020-09-09
FDA Recalls Skin Guard 24 Hand Sanitizing Towelettes for Unapproved Methanol
SG24 LLC is recalling Skin Guard 24 hand sanitizing towelettes because they contain unapproved methanol and lack FDA approval.
Product
Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing Towelette packaged in 2.5 x 3.75 packets, Dist by: SG24 LLC, Bolingbroke, GA 31004
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1570-2020·2020-09-09
Hand Sanitizer Recalled for Methanol Contamination
AAA Cosmetica is recalling bio aaa Advance Hand Sanitizer because it contains methanol. Consumers should stop using the product.
Product
bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation 1341 SW 21 Terrance, Fort Lauderdale, Florida Exported By: E. Audicode S.A. de C.V. Manufactured By: AAA Cosmetica S.A. de C.V. UPC 7 502272 12111 5
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1472-2020·2020-09-09
Sundial Blue Vervain Herbal Product Recalled for Unapproved Drug Claims
Sundial Herbal Products is recalling Blue Vervain herbal products under a permanent injunction because the products are misbranded and deemed unapproved drugs.
Product
"SUNDIAL***Traditional Herbal Products***TRADITIONAL ORGANIC HERBS***BLUE VERVAIN***1oz.***USES:FEMALE PROBLEMS, WORMS & PARASITES***"; packaged in clear plastic zip-top bags
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1571-2020·2020-09-09
SkinGuard 24 Hand Sanitizer Recalled for Unapproved Methanol Content
SG24 LLC is recalling SkinGuard 24 All-Day Hand Sanitizer because it is an unapproved new drug containing methanol.
Product
SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147103
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1559-2020·2020-09-09
Hand Sanitizer Recalled for Potential Methanol Contamination
Roqueplast is recalling Command Brands GelAnti Bac hand sanitizer due to potential contamination with undeclared methanol.
Product
Command Brands GelAnti Bac Instant Hand Sanitizer, 70% Alcohol, , 8 FL OZ 250mL bottle, Roqueplast S.A. de C.V. Cda. Adolfo Manfredi #7 Altizapan de Zaragoza CP 52958 Edo de Mexico UPC 8 52239 00689 2
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1498-2020·2020-09-09
Sundial Herbal Arthritis Formula Recalled for Misbranding and Unapproved Drug Status
Sundial Herbal Products is recalling its Traditional Herbal Formula for Arthritis because the product is misbranded and considered an unapproved drug.
Product
"SUNDIAL***TRADITIONAL HERBAL FORMULA***ARTHRITIS***" packaged in boxes
Category
Drug
Distribution
1 state
SevereFDA (Food)·F-1485-2020·2020-09-09
Sundial Herbal Products Recalls Palo De Brazil Wood Under FDA Injunction
Sundial Herbal Products is recalling Palo De Brazil Wood in New York because the product is misbranded and deemed an unapproved drug.
Product
"***PALO DE BRAZIL***BRASIL WOOD***great to reduce the sugar in the blood and removes gall stone from the kidneys***INSTRUCTIONS. put the wood in pure water and keep in the refrigerator then drink when thirsty***"
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1572-2020·2020-09-09
SkinGuard 24 Hand Sanitizer Recalled for Unapproved Methanol Content
SG24 LLC is recalling SkinGuard 24 Hand Sanitizer because it is an unapproved new drug containing methanol.
Product
SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147125
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1573-2020·2020-09-09
Skin Guard 24 Hand Sanitizer Recalled for Unapproved Methanol Content
SG24 LLC is recalling Skin Guard 24 All-Day Hand Sanitizer pens because they are labeled to contain methanol, making them unapproved new drugs.
Product
Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147097
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1553-2020·2020-09-02
SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross Contamination
SCA Pharmaceuticals is recalling Heparin Sodium 10,000 units injection containers due to cross contamination with undeclared benzyl alcohol and missing parabens.
Product
Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0652-46, Bar Code 70004065246.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1551-2020·2020-09-02
SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross Contamination
SCA Pharmaceuticals is recalling 366 containers of Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL due to cross-contamination with undeclared benzyl alcohol.
Product
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-44, Bar Code 70004065044.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1534-2020·2020-09-02
Medichem Recalls Chlorhexidine Gluconate Due to Serratia marcescens Contamination
Medichem S.A. is recalling Chlorhexidine Gluconate 0012 for manufacturing due to microbial contamination with Serratia marcescens.
Product
Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Celra, 17460, Celra, Girona (Spain/Espana); Fructuos Gelabert, 6-8, 08970, Sant Joan Despi, Barcelona (Spain/Espana) NDC 53296-0012-0
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1552-2020·2020-09-02
SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross Contamination
SCA Pharmaceuticals is recalling Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL single-dose containers due to cross-contamination with undeclared benzyl alcohol.
Product
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-46, Bar Code 70004065046.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1542-2020·2020-09-02
Par Pharmaceutical Recalls BusPIRone Hydrochloride Tablets Due to Impurity Failure
Par Pharmaceutical Inc. is recalling 11,347 bottles of BusPIRone Hydrochloride Tablets 7.5 mg because they failed impurity and degradation specifications.
Product
BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1550-2020·2020-09-02
SCA Pharmaceuticals Recalls Heparin Sodium Injection Due to Cross-Contamination
SCA Pharmaceuticals is recalling Heparin Sodium 2,500 units injection containers that contain undeclared benzyl alcohol and lack declared parabens.
Product
Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0655-44, Bar Code 70004065544.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1535-2020·2020-09-02
Aurobindo Recalls Sulfamethoxazole and Trimethoprim Tablets Due to Metal Wire
Aurobindo Pharma USA Inc. is recalling specific lots of Sulfamethoxazole and Trimethoprim tablets because of reports of metal wire in the tablets.
Product
SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1544-2020·2020-09-02
Bayshore Pharmaceuticals Recalls Metformin Hydrochloride Tablets Due to CGMP Deviations
Bayshore Pharmaceuticals is voluntarily recalling 3,984 bottles of Metformin Hydrochloride Extended-Release Tablets due to Current Good Manufacturing Practice (CGMP) deviations.
Product
METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1543-2020·2020-09-02
Bayshore Pharmaceuticals Recalls Metformin Hydrochloride Tablets Due to CGMP Deviations
Bayshore Pharmaceuticals is voluntarily recalling 594 bottles of Metformin Hydrochloride Extended-Release Tablets due to Current Good Manufacturing Practice (CGMP) deviations.
Product
METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1537-2020·2020-09-02
Fresenius Kabi Recalls Dexmedetomidine Injection Due to Lidocaine Contamination
Fresenius Kabi is recalling specific lots of Dexmedetomidine HCl Injection due to trace amounts of lidocaine contamination.
Product
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-05
Category
Drug
Distribution
Distributed nationwide

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3601–3625 of 11819