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

3426–3450 of 17964

HighFDA (Drugs)·D-1488-2022·2022-09-14
Diphenhydramine Solution Recalled Due to Manufacturing Control Deviations
Plastikon Healthcare LLC is recalling Diphenhydramine HCl Oral Solution nationwide due to manufacturing control deficiencies that did not meet Current Good Manufacturing Practice standards.
Product
Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6740-70
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1492-2022·2022-09-14
CORRECTDOSE Children's Allergy Relief Recalled Due to Manufacturing Process Control Deviations
CORRECTDOSE Children's Allergy Relief (Diphenhydramine HCl 12.5 mg per 5 mL) is being recalled nationwide. The FDA determined products were manufactured under conditions with inadequate process control.
Product
CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-302-05 UPC 8 60003 67144 3
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1498-2022·2022-09-14
Difluprednate Eye Drops Recalled for Defective Container Compromising Sterility
CIPLA is recalling 3,468 bottles of Difluprednate Ophthalmic Emulsion nationwide due to defective protective caps that could expose the dropper tip and compromise sterility. No injuries have been reported.
Product
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1481-2022·2022-09-14
Milk of Magnesia Recalled for Manufacturing Process Control Issues
Plastikon Healthcare LLC is recalling Milk of Magnesia USP due to manufacturing process control deviations affecting approximately 92,200 cups distributed nationwide.
Product
MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6840-72.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1485-2022·2022-09-14
Acetaminophen Oral Solution Recalled Due to Manufacturing Control Deviations
Plastikon Healthcare LLC is recalling Acetaminophen Oral Solution nationwide because manufacturing quality controls were not adequately maintained. Affected product was distributed to institutional healthcare settings.
Product
Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6739-71
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1483-2022·2022-09-14
Magnesium Hydroxide and Aluminum Hydroxide Oral Suspension Recalled for Manufacturing Control Issues
Plastikon Healthcare LLC is recalling an antacid oral suspension due to manufacturing control deviations. No illnesses have been reported.
Product
Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1482-2022·2022-09-14
Antacid Suspension Recalled Due to Manufacturing Process Control Deviations
Plastikon Healthcare LLC is recalling multiple lots of antacid suspension because manufacturing processes were not adequately controlled. The product was distributed nationwide to institutions.
Product
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1473-2022·2022-09-07
Prescription Antibiotic Tablets Recalled for Foreign Matter in Active Ingredient
Teva Pharmaceuticals is recalling Neomycin Sulfate Tablets because teflon was found in the active ingredient. Affected lot numbers: 3007830, 3007746, 3007829.
Product
NEOMYCIN SULFATE — NEOMYCIN SULFATE (NEOMYCIN SULFATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1465-2022·2022-09-07
Colgate OPTIC WHITE PRO Series Toothpaste Recalled for Improper Storage
Family Dollar Stores is recalling 1,120 packages of Colgate OPTIC WHITE PRO SERIES toothpaste due to improper temperature storage conditions that deviate from cGMP standards.
Product
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevention, 5% Hydrogen Peroxide, Net Wt. 2.1 OZ. (59 g) UPC 0 35000 99658 9. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1468-2022·2022-09-07
Colgate Anticavity Fluoride Toothpaste Recalled for Improper Storage Conditions
Family Dollar is recalling Colgate OPTIC WHITE CHARCOAL COOL MINT toothpaste (Net Weight 4.2 oz., UPC 0 35000 97872 1) distributed to stores in 11 states due to improper temperature storage during manufacturing.
Product
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT PASTE, Net Wt. 4.2 OZ. UPC 0 35000 97872 1. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1475-2022·2022-09-07
Luxury Isopropyl Alcohol Recalled for Undeclared Ethyl Alcohol
Luxury 70% Isopropyl Alcohol First Aid Antiseptic is recalled because it contains undeclared ethyl alcohol. The product was distributed in Virginia and affects 350,000 bottles across multiple lot numbers.
Product
Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ. (1 PT) 355 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965765.
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-1474-2022·2022-09-07
Isopropyl Alcohol Product Contains Undeclared Ethyl Alcohol
Luxury 70% Isopropyl Alcohol distributed in Virginia by TSM Brands LLC contains undeclared ethyl alcohol, creating a mislabeling hazard. Consumers should stop using the product.
Product
Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-1467-2022·2022-09-07
Colgate Anticavity Fluoride Toothpaste recalled for improper storage conditions
Colgate Anticavity Fluoride Toothpaste OPTIC WHITE ADVANCED ICY FRESH is recalled due to improper temperature storage during manufacturing. Approximately 1,680 packages distributed across 11 U.S. states are affected.
Product
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH, Net Wt. 3.2 OZ. (90 g) UPC 0 35000 97159 3. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1469-2022·2022-09-07
Colgate Anticavity Fluoride Toothpaste Recalled Due to Improper Storage Conditions
Family Dollar Stores recalls 1,400 packages of Colgate Anticavity Fluoride Toothpaste due to improper temperature storage conditions during manufacturing. The product may not meet quality standards.
Product
Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT PASTE. Net Wt. 4.2 OZ. (119 g) UPC 0 35000 45836 0. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1497-2022·2022-09-07
Triamcinolone Acetonide Cream Recalled for Manufacturing Defects
Padagis US LLC is recalling 57,816 tubes of Triamcinolone Acetonide Cream 0.1% nationwide due to manufacturing process deviations. Consumers reported gritty texture and reduced effectiveness.
Product
TRIAMCINOLONE ACETONIDE — TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1471-2022·2022-09-07
Timolol Maleate eye drops recalled for unknown impurity in stability testing
Akorn, Inc. is recalling Timolol Maleate Ophthalmic Solution due to identification of an unknown impurity during 12-month stability testing. No illnesses have been reported.
Product
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1466-2022·2022-09-07
Colgate Anticavity Fluoride Toothpaste recalled for improper storage conditions
Colgate Anticavity Fluoride Toothpaste, Optic White Renewal was recalled after being stored outside appropriate temperature conditions. The recall affects 840 packages distributed to Family Dollar stores in 11 states.
Product
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Peroxide, High Impact White, Net Wt. 3.0 OZ. (85 g) UPC 0 35000 97008 4. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1472-2022·2022-09-07
Nighttime Sleep-Aid tablets recalled due to carton labeling error
CVS Pharmacy is recalling Nighttime Sleep-Aid tablets because the carton incorrectly identifies the active ingredient as doxylamine succinate HCl instead of doxylamine succinate. Approximately 257,064 cartons were distributed nationwide.
Product
Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1470-2022·2022-09-07
Colgate OPTIC WHITE Mouthwash Recalled Due to Improper Storage Conditions
Family Dollar is recalling Colgate Whitening Mouthwash OPTIC WHITE ICY FRESH MINT due to temperature storage deviations. 840 packages were distributed to Family Dollar stores in multiple states.
Product
Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 473 mL UPC 0 35000 67111 0. Dist. by: Colgate-Palmolive Co. New York, NY 10022 U.S.A.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1450-2022·2022-08-31
Allergy Medications Recalled Due to Improper Storage Temperature Conditions
Family Dollar Stores is recalling multiple allergy and sinus medications because they were held outside appropriate storage temperature conditions, which may affect their safety and efficacy.
Product
QP DPHNHDRME ALRGY MIN TBLT 12 CT SKU 900449 QP ALLERGY DIPHENHYDRAMINE 25 MG 48 CT SKU 916003 QP ALLERGY MULTI SYMPTOM CAPLET 24CT SKU 916918 BENADRYL D CHILD ALLERGY SINUS GRAPE 4FO SKU 901738 GOOD SENSE CHILD ALLERGY CHERRY 4 FL OZ SKU 916917 BENADRYL ALLERGY CONGESTN
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1457-2022·2022-08-31
Mucinex FastMax Caplets Cold Flu Recalled for Improper Storage Conditions
Family Dollar Stores is recalling Mucinex FastMax Caplets Cold Flu 4CT (SKU 903372) distributed nationwide from April to June 2022 due to improper storage temperature conditions.
Product
MUCINEX FASTMAX CAPLETS COLD FLU 4CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1420-2022·2022-08-31
PREVACID Lansoprazole 15mg Capsules Recalled Due to Storage Conditions
Family Dollar Stores is recalling PREVACID 24HR Lansoprazole 15mg capsules distributed nationwide from April 30 to June 10, 2022, because the product was stored at improper temperatures in violation of manufacturing standards. Consumers should not use this product and should contact Family Dollar Stores for a refund.
Product
PREVACID 24HR LANSOPRAZOLE 15MG CAP 14CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1431-2022·2022-08-31
Topical Skincare Products Recalled for Improper Storage Conditions
Family Dollar Stores is recalling three topical skincare products distributed nationwide due to storage condition violations in manufacturing.
Product
ST IVES BLKHD CLRNG GREEN TEA SCRUB 6 OZ SKU 2007787 AMBI EXFOLIATING WASH 5 OZ SKU 2097153 CC BLACKHEAD SCRUB 5 OZ SKU 2032021 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1398-2022·2022-08-31
AZO YEAST PLUS 20 CT Recalled Due to Improper Storage Conditions
AZO YEAST PLUS 20 CT has been recalled by Family Dollar Stores due to improper storage temperature conditions that violate CGMP requirements. The product was distributed nationwide from April through June 2022.
Product
AZO YEAST PLUS 20 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1418-2022·2022-08-31
Good Sense Esomeprazole Acid Reducer Recalled for Improper Storage Conditions
Family Dollar Stores is recalling Good Sense Esomeprazole Acid Reducer 20mg bottles due to storage temperature deviations. Affected bottles were distributed between April 30 and June 10, 2022.
Product
GOOD SENSE ESOMEPRAZOLE ACID REDUCER 20MG 42CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Category
Drug
Distribution
Distributed nationwide

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3426–3450 of 17964