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

3901–3925 of 17762

HighFDA (Drugs)·D-0962-2022·2022-06-08
Lidocaine Injectable Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center recalled Lidocaine HCl Injection due to lack of sterility assurance. The recalled lot affects 65,590 pre-filled syringes distributed nationwide.
Product
Lidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-FIlled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0970-2022·2022-06-08
Equate Tartar Control Plus Mouthwash Recalled for Out-of-Specification Formula
Walmart is recalling Equate Tartar Control Plus mouthwash from certain lots because they were found to have active ingredients outside the approved specification.
Product
Equate Tartar Control Plus (Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%) Antiseptic Mouthrise Plus, Antigingivitis/Antiplaque, Blue Mint, 1.5 Liter (50.7 FL OZ) bottle, Distributed By: Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 14800
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0961-2022·2022-06-08
Injectable Labetalol HCl Syringes Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center has recalled 115,640 units of Labetalol HCl Injection due to lack of assurance of sterility. The affected product was distributed nationwide.
Product
Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0971-2022·2022-06-08
Blood Pressure Medication Losartan-HCTZ Recalled for Impurity Deviation
Direct Rx is recalling 81 bottles of Losartan Potassium and Hydrochlorothiazide 100/12.5 mg due to AZIDO impurity exceeding acceptable manufacturing standards. Affected bottles were distributed in Alabama, Georgia, Florida, and Louisiana.
Product
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0976-2022·2022-06-08
AMBI Skincare Fade Cream Recalled for Temperature Storage Deviations
AMBI Skincare Fade Cream is being recalled nationwide due to cGMP violations. The product was stored outside its labeled temperature requirements during manufacturing.
Product
AMBI Skincare Fade Cream Normal Skin, Net Wt. 2 OZ. (56g)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0965-2022·2022-06-08
Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection due to lack of assurance of sterility. Approximately 57,810 syringes were distributed nationwide.
Product
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0958-2022·2022-06-08
Injectable Hydromorphone Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Hydromorphone HCl Injection due to lack of assurance of sterility. The recall affects 6,210 pre-filled syringes distributed nationwide.
Product
Hydromorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL), 30 mL Pre-Filled Syringe, 5 x 30 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-529-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0967-2022·2022-06-08
Phenylephrine HCl Injection Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling Phenylephrine HCl Injection syringes nationwide because the manufacturer cannot assure the product met sterility standards required for injectable medications.
Product
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0951-2022·2022-06-08
Calcium Gluconate Injection Syringes Recalled for Sterility Assurance
Nephron Sterile Compounding Center is recalling 30,180 pre-filled Calcium Gluconate Injection syringes due to lack of sterility assurance. Affected lots CG1003A and CG2001A were distributed nationwide.
Product
Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-950-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0968-2022·2022-06-08
Rocuronium Bromide Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Rocuronium Bromide Injection pre-filled syringes nationwide due to lack of sterility assurance. Approximately 604,080 syringes are affected.
Product
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0950-2022·2022-06-08
Sodium Bicarbonate Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling approximately 13,612 units of 8.4% Sodium Bicarbonate Injection due to lack of assurance of sterility. The product was distributed nationwide.
Product
8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a) 10 x 1 syringe carton, b) 30 x 1 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0966-2022·2022-06-08
Phenylephrine HCl Injection recalled for lack of sterility assurance
Nephron Sterile Compounding Center is recalling Phenylephrine HCl Injection syringes nationwide due to lack of assurance of sterility affecting 76,860 units.
Product
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0974-2022·2022-06-08
Losartan Potassium Tablets Recalled for CGMP Deviations and Elevated Impurity
Strides Pharma Inc. is recalling Losartan Potassium 100 mg tablets nationwide due to CGMP deviations with AZIDO impurity levels above acceptable limits. Patients should contact their healthcare provider to verify if they are affected.
Product
LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0957-2022·2022-06-08
Hydromorphone Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Hydromorphone HCl Injection 50 mg/50 mL pre-filled syringes due to lack of sterility assurance. The recalled product was distributed nationwide.
Product
Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe, 5 x 50 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0956-2022·2022-06-08
Glycopyrrolate Injection Recalled Due to Lack of Sterility Assurance
Nephron is recalling 6,150 units of Glycopyrrolate Injection due to lack of sterility assurance. Healthcare providers should stop using affected lots and contact their supplier for return instructions.
Product
Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-03
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0954-2022·2022-06-08
Fentanyl Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center has recalled 3,532 bags of fentanyl citrate injection due to lack of sterility assurance. The affected lots (FN1088A and FN1089A) were distributed nationwide.
Product
Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag, 10 x 1 IV Bag, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0953-2022·2022-06-08
Nephron Epinephrine Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 134,415 pre-filled syringes of Epinephrine Injection due to lack of assurance of sterility. Affected lots were distributed nationwide; patients and providers should contact their healthcare provider.
Product
Epinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0955-2022·2022-06-08
Glycopyrrolate Injection Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center recalls glycopyrrolate injection (1 mg/5 mL, preservative-free) due to lack of assurance of sterility. Approximately 32,550 pre-filled syringes from lot GL2002B have been distributed nationwide.
Product
Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0960-2022·2022-06-08
Ketamine Hydrochloride Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Ketamine Hydrochloride Injection due to lack of assurance of sterility. The recall affects 107,530 pre-filled syringes distributed nationwide.
Product
Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0963-2022·2022-06-08
Neostigmine Methylsulfate Injection Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling Neostigmine Methylsulfate Injection due to lack of assurance of sterility. The compounded injectable drug may not meet sterile product standards.
Product
Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-902-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0973-2022·2022-06-08
Losartan Potassium Tablets Recalled for Elevated AZIDO Impurity Levels
Strides Pharma Inc. is recalling Losartan Potassium 50 mg tablets distributed nationwide due to AZIDO impurity levels exceeding acceptable FDA manufacturing standards.
Product
LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0969-2022·2022-06-08
Succinylcholine Chloride Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling succinylcholine chloride injection due to lack of sterility assurance. The recall involves 181,560 pre-filled syringes distributed nationwide.
Product
Succinylcholine Chloride Injection, USP, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-920-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0959-2022·2022-06-08
Ketamine Hydrochloride Injectable Recalled Due to Sterility Assurance Issues
Nephron Sterile Compounding Center LLC is recalling 30,290 syringes of Ketamine Hydrochloride Injection due to lack of assurance of sterility. The injectable drug was distributed nationwide.
Product
Ketamine Hydrochloride Injection, USP, 30 mg/3 mL (10 mg/mL), 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-33
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0952-2022·2022-06-08
EPINEPHrine Pre-filled Syringes Recalled for Sterility Assurance Issue
Nephron Sterile Compounding Center is recalling 35,850 pre-filled syringes of EPINEPHrine Injection due to lack of sterility assurance. The affected syringes were distributed nationwide.
Product
EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-544-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0972-2022·2022-06-08
Losartan Potassium tablets recalled for excessive AZIDO impurity
Strides Pharma is recalling approximately 200,407 bottles of Losartan Potassium 25 mg tablets nationwide due to AZIDO impurity levels exceeding acceptable manufacturing limits.
Product
LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
Category
Drug
Distribution
Distributed nationwide

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3901–3925 of 17762