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

3501–3525 of 11852

SevereFDA (Drugs)·D-0078-2021·2020-11-25
Hand Sanitizer Recalled for Methanol Contamination and Low Ethanol Content
Albek De Mexico S.A. De C.V. is recalling NuuxSan hand sanitizer because it contained methanol and had lower ethanol levels than labeled.
Product
NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle, Distributed by PCM North America LLC 9543 Bassonnet ST. STE 307, Houston, TX 77036, Made in Mexico, UPC 7 13620 00017 5
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0080-2021·2020-11-25
Assured Instant Hand Sanitizer Recalled for Methanol Contamination
Albek De Mexico S.A. De C.V. is recalling 27,000 bottles of Assured Instant Hand Sanitizer because the product contained methanol and was below the label claim for ethanol content.
Product
Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0072-2021·2020-11-18
H & H Remedies Recalls White Liniment Due to CGMP Deviations
H & H Remedies, LLC is voluntarily recalling 365 bottles of White Liniment due to Current Good Manufacturing Practice (CGMP) deviations.
Product
White Liniment packaged in a) 1 oz; b) 4 oz.; and c) 6 oz bottles. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0076-2021·2020-11-18
Baxter Recalls Bupivacaine Injection Due to Particulate Matter
Baxter Healthcare is recalling specific lots of Bupivacaine Hydrochloride Injection due to the presence of black and transparent particles in the solution.
Product
Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA, Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213 India,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0057-2021·2020-11-11
Denton Pharma Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
Denton Pharma, Inc. is recalling specific bottles of Metformin Hydrochloride Extended-Release Tablets 500 mg because they contain N-Nitrosodimethylamine (NDMA) above acceptable levels.
Product
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, N
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0058-2021·2020-11-11
Direct Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity
Direct Rx is recalling 88 bottles of Metformin Hydrochloride Extended Release 500 mg in Florida due to NDMA impurity levels above acceptable intake.
Product
METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0068-2021·2020-11-11
Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
Nostrum Laboratories is recalling 20,872 bottles of Metformin Hydrochloride Extended-Release Tablets 500 mg because they contain N-Nitrosodimethylamine (NDMA) above acceptable levels.
Product
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0059-2021·2020-11-11
PD-Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity
PD-Rx Pharmaceuticals is recalling 1,683 bottles of Metformin Hydrochloride Extended Release 500 mg because of NDMA impurity levels above acceptable limits.
Product
METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
Category
Drug
Distribution
16 states
SevereFDA (Drugs)·D-0056-2021·2020-11-11
Denton Pharma Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity
Denton Pharma, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg due to the detection of N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels.
Product
Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0060-2021·2020-11-11
PD-Rx Recalls Metformin Hydrochloride Extended Release Tablets Due to NDMA
PD-Rx Pharmaceuticals is recalling 125 bottles of Metformin Hydrochloride Extended Release tablets because of NDMA impurity levels above acceptable limits.
Product
METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
Category
Drug
Distribution
16 states
SevereFDA (Drugs)·D-0062-2021·2020-11-11
Metformin Hydrochloride Extended Release Tablets Recalled for NDMA Impurity
Marksans Pharma Limited is recalling Metformin Hydrochloride Extended Release tablets due to N-Nitrosodimethylamine (NDMA) impurity levels above acceptable intake limits.
Product
METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0061-2021·2020-11-11
Time-Cap Labs Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
Time-Cap Labs, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 500 mg because the FDA detected the impurity N-Nitrosodimethylamine (NDMA) above acceptable intake levels.
Product
METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0067-2021·2020-11-11
Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
Nostrum Laboratories is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg because the NDMA impurity level exceeds acceptable intake limits.
Product
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0054-2021·2020-11-04
Bausch Health Recalls Subpotent Hydrocortisone Butyrate Cream
Bausch Health is recalling 35,424 tubes of Hydrocortisone butyrate Cream, 0.1%, because the product was found to be subpotent.
Product
Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceuticals a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, By: Ferndale Laboratories, Inc. Ferndale, MI 48220, NDC 68682-270-15
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0050-2021·2020-11-04
RemedyRepack Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity
RemedyRepack Inc. is recalling Metformin Hydrochloride Extended Release 750 mg tablets because of detected NDMA impurity levels above acceptable intake limits.
Product
Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00
Category
Drug
Distribution
1 state
CriticalFDA (Drugs)·D-0035-2021·2020-10-28
Acella Recalls NP Thyroid 15 Tablets Due to Subpotent Levothyroxine
Acella Pharmaceuticals is recalling NP Thyroid 15 tablets because FDA analysis found the levothyroxine content was less than the labeled claim.
Product
NP THYROID 15 — NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0036-2021·2020-10-28
Acella Recalls NP Thyroid 15 Tablets Due to Subpotent Levothyroxine Levels
Acella Pharmaceuticals is recalling NP Thyroid 15 tablets because FDA analysis found the levothyroxine content was less than labeled.
Product
NP THYROID 15 — NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0016-2021·2020-10-14
Direct Rx Recalls Ranitidine 150 mg Tablets Due to NDMA Impurity
Direct Rx is recalling specific lots of Ranitidine 150 mg tablets because an NDMA impurity was detected. The affected products were distributed in Florida and Georgia.
Product
Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0017-2021·2020-10-14
Direct Rx Recalls Ranitidine 300 mg Tablets Due to NDMA Impurity
Direct Rx is recalling 26 bottles of Ranitidine 300 mg tablets because the product was found to contain the NDMA impurity.
Product
Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0005-2021·2020-10-14
PD-Rx Recalls Nature-Throid Tablets Due to CGMP Deviations and Sub-Potency Risk
PD-Rx Pharmaceuticals is recalling 20 bottles of Nature-Throid 1 GR tablets due to CGMP deviations and potential sub-potency. The product was distributed in Arizona and Oklahoma.
Product
Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine (T4) 38 mcg, 100 Tablets per bottle, Rx Only, Pkg By PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127, NDC 43063-819-01.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0018-2021·2020-10-14
Direct Rx Recalls Losartan Potassium 100 mg Tablets Due to Impurity
Direct Rx is recalling 33 bottles of Losartan Potassium 100 mg tablets found to contain an impurity above acceptable levels.
Product
Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30
Category
Drug
Distribution
1 state
CriticalFDA (Drugs)·D-0031-2021·2020-10-07
Blumen Hand Sanitizer Recalled for Methanol and Low Ethanol Content
4e Brands North America is recalling Blumen Advanced Hand Sanitizer because testing found methanol contamination and ethanol levels below the labeled claim.
Product
blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) Packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4, b) 7.5 fl oz / 221 ml bottle, UPC 8 14266 02362 4, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, Sa
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0029-2021·2020-10-07
Blumen Hand Sanitizer Recalled for Methanol and Low Alcohol Content
4e Brands North America is recalling Blumen hand sanitizer bottles and pumps found to contain methanol and less ethanol than labeled.
Product
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 17 fl oz / 503 ml bottle with blue cap or pump bottle, UPC 8 14266 02409 6 c) 33.8 fl oz / 1 L straight or curved bottle, UPC 8 14266 0236
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0033-2021·2020-10-07
Volu-Sol Handrub Sanitizing Solution Recalled for Unapproved Marketing
Volu-Sol, Inc. is recalling handrub sanitizing solution marketed without an approved NDA/ANDA and listing methanol as an inactive ingredient.
Product
Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Alcohol, 7.2% v/v) Topical Solution, 473 mL/ 16 fl oz bottle, Vou-Sol 5095 W 2100 S, Salt Lake City, UT 84120, NDC 74401-800-16
Category
Drug
Distribution
2 states
CriticalFDA (Drugs)·D-0030-2021·2020-10-07
blumen Hand Sanitizer Recalled for Methanol Contamination and Low Ethanol
4e Brands North America is recalling blumen hand sanitizer bottles due to methanol contamination and ethanol levels below the labeled claim.
Product
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost with tea tree oil (70% ethyl alcohol), 33.8 fl oz / 1 L bottle, Distributed in USA and Canada by: 4e Brands 4e Brands Northamerica LLC. 17806 IH-10W, Suite 300, San Antonio, Texas, 78257. Made in Mexico.
Category
Drug
Distribution
Distributed nationwide

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3501–3525 of 11852