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

1801–1825 of 18005

HighFDA (Drugs)·D-0416-2024·2024-04-03
PHENYLephrine Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals recalls PHENYLephrine HCl injectable syringes nationwide due to lack of sterility assurance. The recall affects 1,118 syringes across two lot numbers distributed throughout the USA.
Product
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID fo
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0419-2024·2024-04-03
Pharmaceutical Injection Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals is recalling PHENYLephrine HCl 40 mg injection nationwide due to lack of sterility assurance. Patients should contact their healthcare provider and not use this product.
Product
PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0428-2024·2024-04-03
Oral Contraceptive Tablets Recalled for Failed Dissolution Specifications
Teva Pharmaceuticals is recalling TRI-LO-SPRINTEC oral contraceptive tablets nationwide due to failed dissolution specifications affecting 92,676 cartons.
Product
TRI-LO-SPRINTEC — TRI-LO-SPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0396-2024·2024-04-03
Fentanyl Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals recalls fentanyl 2,500 mcg injection due to lack of sterility assurance. Affected batches were distributed nationwide.
Product
fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0422-2024·2024-04-03
FDA Recalls Sodium Citrate Injectable Solution Due to Sterility Concerns
SCA Pharmaceuticals recalls Sodium Citrate 4% injectable solution syringes (9,624 units) distributed nationwide due to lack of assurance of sterility.
Product
Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 70004090025
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0420-2024·2024-04-03
PHENYLephrine HCl Injectable Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals is recalling PHENYLephrine HCl 800 mcg/10 mL injections due to lack of assurance of sterility. The recall affects 3,671 syringes distributed nationwide.
Product
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code 700040081612.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0410-2024·2024-04-03
Hydromorphone Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals is recalling 909 syringes of HYDROmorphone HCl 30 mg/30 mL injection nationwide due to lack of assurance of sterility. Patients should not use affected lots and consult their healthcare provider.
Product
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0400-2024·2024-04-03
Fentanyl and Bupivacaine Epidural Injection Recalled for Sterility Assurance Issue
SCA Pharmaceuticals recalls 412 cassettes of fentanyl-bupivacaine epidural injection (lots 1223049261 and 1223049724) due to lack of assurance of sterility.
Product
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0289-64, Bar Code 70004028964
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0411-2024·2024-04-03
Labetalol HCl Injection Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals is recalling labetalol HCl injection due to lack of sterility assurance. The recall affects 2,458 syringes distributed nationwide.
Product
labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0406-2024·2024-04-03
HYDROmorphone HCl 6 mg Injectable Syringes Recalled Due to Sterility Assurance Issues
SCA Pharmaceuticals is recalling 1,425 syringes of HYDROmorphone HCl 6 mg/30 mL due to lack of assurance of product sterility. The affected lots were distributed nationwide.
Product
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 70004030018
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0414-2024·2024-04-03
Phenylephrine HCl Injections Recalled Nationwide for Sterility Assurance Issues
SCA Pharmaceuticals is recalling Phenylephrine HCl injections nationwide affecting approximately 33,000 units due to lack of assurance of sterility.
Product
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 70004081012
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0427-2024·2024-04-03
FDA Recalls VCF Contraceptive Film Due to Manufacturing Process Violations
The FDA is recalling VCF Contraceptive Film due to manufacturing process deviations. Apothecus Pharmaceutical Corp. initiated the voluntary recall on March 21, 2024, affecting 17,280 cartons distributed nationwide.
Product
VCF CONTRACEPTIVE — VCF CONTRACEPTIVE (NONOXYNOL-9)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1097-2024·2024-04-03
Bluebonnet Methylfolate Chewables Recalled for Label Unit Error
Bluebonnet Nutrition is recalling EarthSweet Chewables CellularActive Methylfolate 1000 mcg due to a labeling error stating '1000 mg' instead of '1000 mcg' on the front label.
Product
EarthSweet¿ Chewables CellularActive¿ Methylfolate 1000 mcg; 90 chewable tablets packaged in an amber glass botte with purple lid
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0393-2024·2024-03-27
FDA Recalls Unapproved Tianeptine Elixir Drug Product Nationwide
Neptune's Fix Tianeptine Elixir, distributed nationwide by Super Chill Products, is recalled because it contains tianeptine, a substance not approved by the FDA for any medical use in the United States. Consumers should not use this product.
Product
Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0391-2024·2024-03-27
Nicardipine Hydrochloride Injection Recalled Due to Out-of-Specification Organic Impurities
Eugia US LLC is recalling 43,920 vials of Nicardipine Hydrochloride Injection nationwide due to failure to meet organic impurity specifications. No illnesses have been reported.
Product
NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0389-2024·2024-03-27
Digoxin Tablets Recalled Due to Cross Contamination with Mycophenolate Mofetil
Novitium Pharma LLC recalls Digoxin 125mcg tablets nationwide due to cross contamination with mycophenolate mofetil, a different medication. Patients receiving contaminated tablets could experience unintended drug effects.
Product
DIGOXIN — DIGOXIN (DIGOXIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0392-2024·2024-03-27
Morphine Sulfate Ampuls Recalled for Expired Filters in Cartons
Hikma Pharmaceuticals is recalling Infumorph 200 (morphine sulfate) ampuls because the sterile filter in the carton has an earlier expiration date than the medication, potentially compromising sterility.
Product
INFUMORPH 200 — INFUMORPH 200 (MORPHINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0390-2024·2024-03-27
Nicardipine Hydrochloride Injection Recalled for Out-of-Specification Organic Impurities
Eugia US LLC is recalling Nicardipine Hydrochloride Injection nationwide due to failed impurity specifications. The 335,940 affected vials contain organic impurities exceeding acceptable standards.
Product
NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0383-2024·2024-03-20
TRP Natural Eyes Red Eye Relief eye drops recalled for sterility concerns
The FDA is recalling 106,704 bottles of TRP Natural Eyes Red Eye Relief eye drops due to lack of sterility assurance. Consumers should stop using the product and contact a healthcare provider if they experience eye irritation or infection.
Product
TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0376-2024·2024-03-20
TRP Blur Relief Eye Drops Recalled Nationwide for Sterility Assurance Failure
TRP Blur Relief sterile eye drops (Lot #B905) are recalled due to inability to assure product sterility. Approximately 7,248 bottles were distributed nationwide.
Product
TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0388-2024·2024-03-20
Prescription Telmisartan Recalled for Failed Blend Uniformity Specifications
Micro Labs Limited is recalling 118,080 bottles of Telmisartan 40mg tablets due to failed blend uniformity specifications. The affected lots (SFBG024, SFBG025) were distributed in Puerto Rico, Tennessee, and Rhode Island.
Product
Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873, NDC 42571-227-30.
Category
Drug
Distribution
3 states
HighFDA (Drugs)·D-0368-2024·2024-03-20
Prescription drug Febuxostat recalled due to manufacturing contamination
Sun Pharmaceutical is recalling 47,520 bottles of Febuxostat 40mg tablets nationwide due to microbial contamination found in manufacturing equipment. The FDA classified this as a Class II recall; no illnesses have been reported.
Product
FEBUXOSTAT — FEBUXOSTAT (FEBUXOSTAT)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0370-2024·2024-03-20
Potassium Chloride Injection Recalled Due to Pinhole Container Defects
B. Braun Medical is recalling 22,752 bags of Potassium Chloride for Injection Concentrate nationwide due to pinholes in container bags that compromise sterility assurance. Affected lots are J2S007 (expires 12/31/2024) and J3A115 (expires 01/31/2025).
Product
POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0371-2024·2024-03-20
FDA Recalls Rocuronium Bromide Injections Due to Improper Storage
McKesson Medical-Surgical is recalling Rocuronium Bromide Injection vials due to storage outside label specifications. Seventy vials were distributed to three healthcare accounts in New Mexico, Arizona, and Utah.
Product
ROCURONIUM BROMIDE — ROCURONIUM BROMIDE (ROCURONIUM BROMIDE)
Category
Drug
Distribution
3 states
HighFDA (Drugs)·D-0384-2024·2024-03-20
FDA Recalls HylaTears Lubricant Eye Drops for Sterility Assurance Issue
Optikem International is recalling 46,621 bottles of hyalogic For Dry Eyes, HylaTears Lubricant Eye Drops due to lack of assurance of sterility. The product is distributed nationwide.
Product
hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150
Category
Drug
Distribution
Distributed nationwide

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1801–1825 of 18005