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

2326–2350 of 11852

SevereFDA (Drugs)·D-1478-2022·2022-09-14
Antacid Medication Recalled Nationwide for Microbial Contamination Risk
Plastikon Healthcare LLC is recalling 220,500 cups of antacid containing magnesium hydroxide and aluminum hydroxide due to microbial contamination.
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-1499-2022·2022-09-14
Difluprednate Eye Drops Recalled for Defective Container Sterility Risk
Cipla is recalling 117,844 bottles of Difluprednate eye drops nationwide due to defective containers where the protective cap can break, potentially exposing the dropper tip and compromising sterility.
Product
DIFLUPREDNATE — DIFLUPREDNATE (DIFLUPREDNATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1486-2022·2022-09-14
Acetaminophen Oral Solution Recalled for Manufacturing Process Control Failures
Plastikon Healthcare LLC is recalling acetaminophen oral solution (650 mg per 20.3 mL cup) distributed nationwide due to manufacturing process control failures.
Product
Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 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 0904-6820-76
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1487-2022·2022-09-14
Calcium Carbonate Oral Suspension Recalled Due to Manufacturing Control Deviations
Plastikon Healthcare recalls 49,280 cups of Calcium Carbonate Oral Suspension (1250 mg/5 mL) distributed nationwide due to manufacturing process control failures during production.
Product
CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-7098-94
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1480-2022·2022-09-14
FDA Recalls Milk of Magnesia USP for Manufacturing Control Deviations
Plastikon Healthcare LLC is recalling 502,600 cups of Milk of Magnesia USP due to manufacturing process control deviations. Consumers should discontinue use and consult their healthcare provider if concerned.
Product
MILK OF MAGNESIA USP, 2400 mg/30 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 0904-6846-73.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1484-2022·2022-09-14
Acetaminophen Oral Solution 160 mg Recalled for Manufacturing Control Deviations
Acetaminophen Oral Solution 160 mg/5 mL (290,270 cups) recalled nationwide due to CGMP manufacturing control deviations. Product was distributed to institutional healthcare facilities.
Product
Acetaminophen Oral Solution 160 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 0904-6738-70
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1496-2022·2022-09-14
Sodium Chloride Ophthalmic Ointment Recalled for Turbidity and Sterility Concerns
Akorn, Inc. is recalling Sodium Chloride Ophthalmic Ointment due to turbidity found during sterility testing. The FDA expanded the recall to additional lots sharing potential root cause.
Product
Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35
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-1491-2022·2022-09-14
Guaifenesin and Dextromethorphan Cough Syrup Recalled for Manufacturing Control Deviations
Plastikon Healthcare LLC is recalling Guaifenesin and Dextromethorphan cough syrup cups distributed nationwide due to manufacturing processes that were not adequately controlled.
Product
GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 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 0904-6980-72
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1490-2022·2022-09-14
Guaifenesin and dextromethorphan liquid medication recalled for manufacturing control issues
Plastikon Healthcare LLC is recalling guaifenesin and dextromethorphan liquid medication (280,500 cups) distributed nationwide due to manufacturing control deviations in production.
Product
GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 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 0904-6844-70
Category
Drug
Distribution
Distributed nationwide
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-1493-2022·2022-09-14
CORRECTDOSE Children's Pain Relief and Fever Reducer Acetaminophen Recalled for Manufacturing Control Violations
CORRECTDOSE Children's Fever Reducer (160 mg/5 mL acetaminophen) has been recalled due to manufacturing control deviations. The recall affects 1,464 units distributed nationwide.
Product
CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 0
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1495-2022·2022-09-14
Lidocaine Hydrochloride Jelly Recalled Due to cGMP Deviations and Turbidity
Akorn, Inc. is recalling 82,689 tubes of Lidocaine Hydrochloride Jelly USP, 2%, due to cGMP deviations and turbidity discovered during sterility testing. The recall affects multiple lots distributed nationwide.
Product
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
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
HighFDA (Drugs)·D-1489-2022·2022-09-14
Diphenhydramine HCl Oral Solution Recalled for Manufacturing Process Deviations
Plastikon Healthcare LLC is recalling 349,100 cups of Diphenhydramine HCl Oral Solution due to manufacturing process control deviations. The product was distributed nationwide for institutional use only.
Product
Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 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 0904-6741-72
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1494-2022·2022-09-14
Children's Cough Medicine Recalled for Manufacturing Control Deficiency
CORRECTDOSE Children's Cough & Chest Congestion DM is being recalled nationwide due to manufacturing process control deviations that did not meet required quality standards.
Product
CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60mL), packaged in 12-5 individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-321-05 UPC 8 60003 67146 7
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
HighFDA (Drugs)·D-1444-2022·2022-08-31
AFRIN No Drip Severe Congestion Recalled for Improper Storage Temperature
Family Dollar Stores is recalling AFRIN No Drip Severe Congestion 0.5 FL oz due to improper storage temperature conditions (CGMP deviation). The product was distributed to specific Family Dollar locations from April 30 through June 10, 2022.
Product
AFRIN NO DRIP SEVERE CONGESTION 0.5FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1390-2022·2022-08-31
Rubbing Alcohol Recalled for Improper Storage Temperature Conditions
Family Dollar Stores recalled Ready In Case 50% Wintergreen Rubbing Alcohol (16 fl oz) distributed April 30–June 10, 2022 due to improper storage temperature conditions.
Product
READY IN CASE RUBBING ALCHL 50 PCT WNTRGRN 16 FLOZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1408-2022·2022-08-31
Witch hazel product recalled for improper storage temperature conditions
Witch hazel product distributed to Family Dollar Stores from April through June 2022 was stored at improper temperatures. The FDA issued a Class II recall due to manufacturing and quality control (CGMP) deviations.
Product
TN DICKINSON WITCH HAZEL 16 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1365-2022·2022-08-31
Sunscreen Products Recalled Due to Improper Storage Temperature Conditions
Family Dollar Stores is recalling multiple sunscreen products that were stored outside appropriate temperature conditions. The storage deviation may have reduced the products' sun protection effectiveness.
Product
BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2096102 HAWAIIAN TROPIC TANNING OIL SPRAY PUMP SPF 25 8 FL OZ SKU 2096111 BANANA BOAT SPORT ULTRAMIST SPRAY SPF 65 6 OZ SKU 2096117 COPPERTONE WATERBABIES LOTION SPF 50 8 FL OZ SKU 20
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1462-2022·2022-08-31
Vicks DayQuil NyQuil Combination Pack Recalled for Storage Temperature
Family Dollar Stores is recalling Vicks DayQuil/NyQuil Liquid combination packs (SKU 903367) distributed from April 30 to June 10, 2022, due to improper storage temperatures that may affect medication effectiveness.
Product
VICKS DAYQUIL NYQUIL LIQ COMB PK 6 FLOZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Category
Drug
Distribution
Distributed nationwide

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2326–2350 of 11852