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

5776–5800 of 17974

LowFDA (Drugs)·D-0045-2021·2020-10-28
ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date
ANI Pharmaceuticals is recalling 13,248 bottles of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of 18 months.
Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0042-2021·2020-10-28
FDA Recalls Desflurane Liquid for Inhalation Due to Container Leaks
eVenus Pharmaceutical Laboratories is recalling Desflurane Liquid for Inhalation because the containers may be leaking. The recall affects 9,210 units distributed in Colorado.
Product
DESFLURANE — DESFLURANE (DESFLURANE)
Category
Drug
Distribution
1 state
LowFDA (Drugs)·D-0046-2021·2020-10-28
ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date
ANI Pharmaceuticals is recalling specific lots of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of the correct 18-month date.
Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0048-2021·2020-10-28
ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date
ANI Pharmaceuticals is recalling 34,968 bottles of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of 18 months.
Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0044-2021·2020-10-28
ANI Pharmaceuticals Recalls Amphetamine Capsules Due to Incorrect Expiration Date
ANI Pharmaceuticals is recalling specific lots of amphetamine extended-release capsules because they were labeled with a 24-month expiration date instead of 18 months.
Product
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0098-2021·2020-10-21
Smart Care Hand Sanitizer Recall Due to Misleading Packaging Resembling Food and Drink
The FDA is recalling Smart Care hand sanitizers because their container packaging is designed to look like food and drink pouches, potentially confusing consumers.
Product
Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL), labeled as a) Paw Patrol (Item #: 92321-144, UPC 8 50016 92321 9, NDC 70108-042-01); b) JoJo Siwa Dreamer (Item #: 92320-144, UPC 8 50016 92320 2, NDC 70108-044-01); c) Hot Wheels (Item #: 92317-144,
Category
Consumer Product
Distribution
2 states
ModerateFDA (Drugs)·D-0034-2021·2020-10-21
Leadiant Recalls Subpotent Cystaran Ophthalmic Solution
Leadiant Biosciences is recalling 1,380 bottles of Cystaran ophthalmic solution because testing found decreased levels of the active ingredient.
Product
CYSTARAN — CYSTARAN (CYSTEAMINE HYDROCHLORIDE)
Category
Drug
Distribution
0 states
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-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-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
ModerateFDA (Drugs)·D-0010-2021·2020-10-14
Calvin Scott Recalls Diethylpropion Tablets Due to Missing Stability Studies
Calvin Scott & Company is recalling specific lots of Diethylpropion 75 mg tablets because they were repackaged without supporting stability studies.
Product
Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1477-01
Category
Drug
Distribution
5 states
ModerateFDA (Drugs)·D-0009-2021·2020-10-14
Calvin Scott Recalls Diethylpropion Tablets Due to Stability Deviations
Calvin Scott & Company is recalling specific lots of Diethylpropion 25 mg tablets because they were repackaged without supporting stability studies.
Product
Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1475-01
Category
Drug
Distribution
5 states
ModerateFDA (Drugs)·D-0011-2021·2020-10-14
Calvin Scott Recalls Phentermine Capsules Due to Stability Study Deviations
Calvin Scott & Company is recalling specific lots of Phentermine 30 mg capsules because they were repackaged without supporting stability studies.
Product
Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-0597-10
Category
Drug
Distribution
5 states
LowFDA (Drugs)·D-0015-2021·2020-10-14
Pharmaceutical Associates Recalls Citalopram Oral Solution Due to Impurities
Pharmaceutical Associates Inc. is recalling Citalopram Oral Solution due to high impurity levels found during stability testing.
Product
Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0019-2021·2020-10-14
VistaPharm Recalls Nystatin Oral Suspension Due to Impurity
VistaPharm is recalling Nystatin Oral Suspension because one lot failed impurity specifications. The affected product was distributed nationwide.
Product
NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,
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-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
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
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
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-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-0023-2021·2020-10-07
Blumen Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
4e Brands North America is recalling Blumen Advanced Hand Sanitizer due to manufacturing in a facility associated with methanol contamination.
Product
blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), 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 b) 33.8 fl. oz./1L bottle, UPC 8 14266 02369 3, Distributed in USA and Canada By: 4e Brands No
Category
Consumer Product
Distribution
Distributed nationwide

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5776–5800 of 17974