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

2776–2800 of 5063

HighFDA (Drugs)·D-0438-2023·2023-03-15
NatraBio Cold and Sinus Nasal Spray Recalled for Manufacturing Deviation
Nutraceutical Corporation is recalling NatraBio Cold & Sinus Nasal Spray (0.8 FL Oz) lot 222016 due to manufacturing deviations and product discoloration. The product was distributed nationwide.
Product
NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions NatraBio Shelburne Falls, MA 01370 USA, UPC 3 71400 55711 2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0439-2023·2023-03-15
NaturalCare bioAllers Homeopathic Drops Recalled for Manufacturing Quality Defect
Nutraceutical Corporation is recalling NaturalCare bioAllers homeopathic liquid drops nationwide due to a raw material manufacturing quality issue. The recall affects lot 222076 with an expiration date of 03/27.
Product
NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd. for Nutraceutical Corp. NaturalCare Park City, UT, 84098 USA
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0457-2023·2023-03-15
Drug Recall: Purely Soothing MSM Nasal Spray due to manufacturing deviations
Pharmedica USA is recalling Purely Soothing MSM Nasal Spray (15%, Lot #1808051) due to manufacturing practice violations. The recall affects 995 bottles distributed nationwide and internationally.
Product
Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034 91380 5
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0442-2023·2023-03-15
Phenylephrine HCl syringe recalled for manufacturing practice deviations
Phenylephrine HCl syringe recalled for manufacturing practice deviations. 13,445 units distributed nationwide were recalled by Denver Solutions, LLC.
Product
Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0435-2023·2023-03-15
Heparin Sodium Injection Recalled Due to Labeling Issue
Sagent Pharmaceuticals is recalling 28,875 vials of Heparin Sodium Injection nationwide due to a labeling issue. Healthcare providers should verify patient medication before administration.
Product
HEPARIN SODIUM — HEPARIN SODIUM (HEPARIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0446-2023·2023-03-15
Drug Recall: Alcolado Relampago Topical for Manufacturing Practice Deviations
Ecometics recalls Alcolado Relampago topical product nationwide due to Current Good Manufacturing Practice deviations. About 18,000 bottles in 7 oz and 16 oz sizes were distributed in the U.S.
Product
Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 ml) and b) 16 fluid oz. (472 ml) bottles, Distributed by: The Larkspur Group Inc. South Norwalk, CT 06854
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0451-2023·2023-03-15
Sodium fluoride oral rinse recalled for manufacturing deviations
Activator Concentrate, a sodium fluoride oral rinse manufactured by Ecometics, Inc., was voluntarily recalled due to manufacturing practice deviations. The recall affected 34,320 bottles distributed nationwide.
Product
Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for: All USA Direct LLC, Broadview, IL 60155
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0454-2023·2023-03-15
OTC Hemorrhoidal Ointment Recalled for Missing Lot and Expiration Date
Akron Pharma is recalling Dibucaine 1% Hemorrhoidal Ointment due to incorrect or missing lot and expiration date information on the label. This labeling error affects 4,416 tubes distributed nationwide.
Product
DIBUCAINE — DIBUCAINE (DIBUCAINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0448-2023·2023-03-15
FDA Recalls Unguentine Original Ointment for Manufacturing Practice Deviations
Ecometics, Inc. has voluntarily recalled Unguentine Original Ointment for Burns due to manufacturing practice deviations. The recall affects 20,746 units distributed nationwide.
Product
Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0440-2023·2023-03-15
NaturalCare Children's Allergy Care Homeopathic Drops Recalled for CGMP Deviation
Nutraceutical Corporation is recalling NaturalCare children's homeopathic allergy drops (Lot 222148) nationwide due to a manufacturing deviation in raw materials. No illnesses have been reported.
Product
NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ( 30mL), Mfd. Nutraceutical Corp., Salt Lake City, UT, 84101 USA, UPC 3 71402 30101 0
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0447-2023·2023-03-15
Medicated Balm Recalled for Manufacturing Process Deviations
Ecometics, Inc. is voluntarily recalling Vencedor medicated balm (capsaicin 0.028%) nationwide due to manufacturing process deviations. The recall affects Lot #2E021A with expiration date January 2025.
Product
Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The Larkspur Group Inc. Norwalk, CT 06854
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0449-2023·2023-03-15
Drug manufacturer recalls Soltice Quick-RUB nationwide due to manufacturing deviations
Ecometics, Inc. recalled Soltice Quick-RUB nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This was a voluntary recall initiated by the manufacturer in February 2023.
Product
Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars and b) 3 Oz (85g) plastic jars
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0437-2023·2023-03-15
FDA Recalls NaturalCare bioAllers Nasal Spray Due to Manufacturing Defects
Nutraceutical Corporation recalls NaturalCare bioAllers Allergy Nasal Spray nationwide due to manufacturing quality deviations in raw materials. The recalled lots show discoloration and do not meet FDA Good Manufacturing Practice standards.
Product
NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp., NaturalCare Park City, UT, 84098 USA, UPC 3 71400 70801 9
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0450-2023·2023-03-15
FDA Recalls Nose Better Gel Due to Manufacturing Process Deviations
Ecometics, Inc. is recalling Nose Better Gel nationwide due to manufacturing process deviations (CGMP violations). The firm-initiated voluntary recall affects 37,968 units with lot number 1E253A.
Product
Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0443-2023·2023-03-15
FDA Class II: Phenylephrine Injection Recalled for Manufacturing Deviations
Denver Solutions is recalling 325,300 units of Phenylephrine HCl injection due to Current Good Manufacturing Practice deviations. The product was distributed nationwide, including to government facilities.
Product
Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0452-2023·2023-03-15
Unguentine Original Pain Relief Ointment Recalled for Manufacturing Process Deviations
Unguentine Original Pain Relief Ointment is being recalled due to manufacturing process deviations. The FDA-led voluntary recall affects nationwide distribution.
Product
Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packaged in 1 oz. (28.3g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0453-2023·2023-03-08
PrimeZEN Black 6000 Capsule Recalled for Undeclared Pharmaceutical Ingredients
The FDA is recalling PrimeZEN Black 6000 capsules distributed nationwide because they contain undeclared sildenafil and tadalafil. The product is unapproved and was marketed without FDA authorization.
Product
PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0415-2023·2023-03-08
FDA Recalls Tadalafil Tablets Due to Manufacturing Practice Deviations
Accord Healthcare's Tadalafil 5 mg tablets are being recalled due to deviations from current good manufacturing practices identified during an FDA inspection. Approximately 1,113,264 bottles were distributed across the United States, Puerto Rico, and Canada.
Product
TADALAFIL — TADALAFIL (TADALAFIL)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0361-2023·2023-03-08
Phenylephrine HCl Injection Recalled for Sterility Assurance Deficiency
Nephron is recalling 24,870 Phenylephrine HCl Injection vials nationwide due to lack of sterility assurance. No illnesses have been reported.
Product
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-301-10.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0402-2023·2023-03-08
Phenylephrine Hydrochloride Injection Recalled for Manufacturing Practice Deviations
Accord Healthcare is recalling 5,090 vials of Phenylephrine Hydrochloride Injection due to manufacturing deviations found during an FDA inspection. Affected batches include R2101570, R2101574, and R2101576, distributed in the United States, Puerto Rico, and Canada.
Product
Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-465-31, UPC 3 16729 46531 1; Carton
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0396-2023·2023-03-08
Glycopyrrolate Injection, USP recalled for manufacturing practice deviations
Accord Healthcare recalls Glycopyrrolate Injection USP following FDA inspection identifying manufacturing deviations. Approximately 23,814 vials distributed to the US, Puerto Rico, and Canada are affected.
Product
GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0377-2023·2023-03-08
FDA Recalls Accord Healthcare Buspirone 15 mg Tablets for Manufacturing Deviations
Accord Healthcare is recalling 10,992 bottles of Buspirone Hydrochloride 15 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing quality control deviations found during an FDA inspection.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0372-2023·2023-03-08
Atorvastatin Calcium tablets recalled due to manufacturing practice deviations
Accord Healthcare is recalling Atorvastatin Calcium 20 mg tablets due to manufacturing practice deviations found during an FDA inspection. The affected products were distributed in the United States, Puerto Rico, and Canada.
Product
ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0366-2023·2023-03-08
Accord Healthcare Recalls Aripiprazole Tablets Due to Manufacturing Deviations
Accord Healthcare is recalling approximately 1.1 million bottles of Aripiprazole 5mg tablets due to Good Manufacturing Practice deviations identified during an FDA inspection. No illnesses or injuries have been reported.
Product
ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0427-2023·2023-03-08
Ropinirole tablets recalled due to manufacturing practice deviations
Accord Healthcare is recalling Ropinirole 1 mg tablets due to manufacturing deviations identified during FDA inspection. No illnesses have been reported.
Product
ROPINIROLE — ROPINIROLE (ROPINIROLE)
Category
Drug
Distribution
0 states

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