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

1026–1050 of 8579

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-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-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-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-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
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-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-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
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-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
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-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
SevereFDA (Drugs)·D-0032-2021·2020-10-07
Losartan Pot/HCTZ 50/12.5 mg Recalled Due to Impurity Detection
Direct Rx is recalling 33 bottles of Losartan Pot/HCTZ 50/12.5 mg tablets distributed in Florida due to trace amounts of impurity NMBA.
Product
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0002-2021·2020-10-07
Sun Pharmaceuticals Recalls RIOMET ER Due to NDMA Impurity
Sun Pharmaceuticals is recalling RIOMET ER (metformin hydrochloride) oral suspension because it contains the impurity NDMA.
Product
RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx Only Manufactured by: Sun Pharmaceuticals Industries Limited Mohali, India Distributed by: Sun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 NDC 10631-019-1
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0022-2021·2020-10-07
Blumen Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
4e Brands North America is recalling Blumen Advanced Instant Hand Sanitizer due to manufacturing in a facility associated with methanol contamination.
Product
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% ethyl alcohol), Packaged as a) 18 fl oz / 532 ml bottle, UPC 8 14266 02408 9 b) 33.8 fl oz / 1L bottle, UPC 8 14266 02374 7, Distributed in USA and Canada BY: 4e Brands Northamer
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0025-2021·2020-10-07
Blumen Aloe Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
4e Brands North America is recalling Blumen Aloe Advanced Hand Sanitizer because it was manufactured in a facility associated with methanol contamination, representing poor manufacturing practices.
Product
blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), 3.4 fl. oz./100 mL bottle, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico. UPC 8 14266 02358 7
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0026-2021·2020-10-07
ASSURED Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
4e Brands North America is recalling ASSURED Instant Hand Sanitizer due to manufacturing in a facility associated with methanol contamination, representing poor CGMPs.
Product
ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49069 8 b) 10 fL oz / 296 ml bottle, UPC 6 39277 49069 8, Distributed by Geenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mex
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0027-2021·2020-10-07
Assured Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
4e Brands North America is recalling Assured Instant Hand Sanitizer due to manufacturing in a facility associated with methanol contamination, representing poor CGMP practices.
Product
ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49070 4 b) 10 fL oz / 295 ml bottle, UPC 6 39277 49070 4, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0024-2021·2020-10-07
blumen Clear Advanced Hand Sanitizer Recalled for CGMP Deviations
4e Brands North America is recalling blumen Clear Advanced Hand Sanitizer because it was manufactured in a facility associated with methanol contamination, representing poor Current Good Manufacturing Practices.
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) 7.5 fl oz / 221 ml bottle, UPC 8 14266 02362 4 c) 15.2 fl oz (450 ml) bottle, UPC 8 14266 02392 1, d) 17 fl oz / 503 ml bottle with blue c
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0028-2021·2020-10-07
Modesa Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
4e Brands North America is recalling Modesa hand sanitizer because it was manufactured in a facility associated with methanol contamination, representing poor manufacturing practices.
Product
Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico. UPC 0 32251 49935 7
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1595-2020·2020-09-30
Protein Shoppe Recalls Red-E Tablets Tainted With Sildenafil
The Protein Shoppe is recalling Red-E Tablets found to contain sildenafil, an unapproved drug for erectile dysfunction. The product was marketed without FDA approval.
Product
Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1587-2020·2020-09-30
Gelbac T Hand Gel Recalled for Methanol Contamination
Incredible Products is recalling Gelbac T Antibacterial Hand Gel because it contains methanol and is sub-potent for ethanol.
Product
Incredible Products Gelbac T Antibacterial Hand Gel (ethyl alcohol 80%), Kills 99.9% bacteria and germs, a) 4.2 Oz./125 mL bottle, NDC: 71761-000-00, UPC: 7502278002555, Distributed by Pacific Coast Global Inc. Chula Vista, CA 91911, Made in Mexico b) 33.8 Oz./1 L, UPC: 750227800
Category
Drug
Distribution
2 states

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1026–1050 of 8579