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

1626–1650 of 5047

HighFDA (Drugs)·D-0417-2024·2024-04-03
Injectable Phenylephrine Recall Due to Sterility Assurance Failure
SCA Pharmaceuticals recalled approximately 8,050 syringes of PHENYLephrine HCl injection nationwide due to lack of assured sterility. Affected lots have expiration dates from November 2023 to June 2024.
Product
PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0407-2024·2024-04-03
Hydromorphone Injection Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals recalls 1,023 syringes of Hydromorphone Injection nationwide due to lack of sterility assurance. No illnesses have been reported.
Product
HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0397-2024·2024-04-03
Fentanyl-Bupivacaine Epidural Injection Recalled for Sterility Assurance Failure
SCA Pharmaceuticals is recalling 242 bags of fentanyl-bupivacaine epidural injection due to lack of assurance of sterility. The affected lot may not meet required sterility standards.
Product
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-32, Bar Code 70004023132
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0401-2024·2024-04-03
FDA Recalls Fentanyl-Bupivacaine Injection Due to Sterility Assurance Concerns
SCA Pharmaceuticals is recalling 130 cassettes of a fentanyl-bupivacaine epidural injection distributed nationwide due to lack of assurance of sterility.
Product
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% 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 70004-0251-64, Bar Code 70004025164
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0421-2024·2024-04-03
Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals is recalling Phenylephrine HCl 800 mcg/10 mL injections due to lack of assurance that the product is sterile. The recall affects 2,427 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-K, Bar Code 700040081612. (same finished product as F078140, but with RFID f
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0405-2024·2024-04-03
HYDROmorphone Injection Syringes Recalled for Sterility Assurance Issue
SCA Pharmaceuticals is recalling HYDROmorphone HCl injection syringes due to lack of assurance of sterility. The recall affects 5,734 syringes distributed nationwide.
Product
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-16, Bar Code 70004030016
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0402-2024·2024-04-03
fentaNYL 1,250 mcg Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals is recalling fentaNYL 1,250 mcg/25 mL injection syringes due to lack of sterility assurance. The nationwide recall affects 1,259 syringes; patients should contact their healthcare provider.
Product
fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0200-17, Bar code 70004020017
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-0413-2024·2024-04-03
Neostigmine methylsulfate injection recalled nationwide due to sterility concerns
SCA Pharmaceuticals is recalling 1,122 syringes of neostigmine methylsulfate injection nationwide due to inability to assure product sterility. The affected lot is 1223048138 (expiration 1/31/24).
Product
neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0408-2024·2024-04-03
HYDROmorphone Injectable Recalled Due to Sterility Assurance Failure
SCA Pharmaceuticals is recalling HYDROmorphone HCl injections due to lack of assurance of sterility. Patients who received the affected lot should contact their healthcare provider.
Product
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 7004030317
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0423-2024·2024-04-03
Succinylcholine chloride injection recalled for lack of sterility assurance
SCA Pharmaceuticals recalls Succinylcholine Chloride 200 mg/10mL injectable due to lack of assured sterility. The recall affects 8,755 syringes distributed nationwide.
Product
SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-12, Bar Code 70004090812
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0415-2024·2024-04-03
Phenylephrine Injectable Drug Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals is recalling phenylephrine HCl injection syringes nationwide due to inability to assure sterility. Patients using recalled lots should contact their healthcare provider.
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, Bar Code 70004081011
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
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-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-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-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-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-0378-2024·2024-03-20
TRP Natural Eyes Dryness Relief Eye Drops Recalled for Lack of Sterility Assurance
Optikem International, Inc. is recalling TRP Natural Eyes Dryness Relief eye drops due to lack of assurance of sterility. The product was distributed nationwide in the USA.
Product
TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0379-2024·2024-03-20
TRP Eye Strain Relief Eye Drops Recalled Due to Lack of Sterility Assurance
Optikem International recalls TRP Eye Strain Relief eye drops nationwide due to lack of assurance of sterility. Affected units are 10 mL bottles with Lot E206.
Product
TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0381-2024·2024-03-20
TRP Natural Eyes eye drops recalled due to lack of sterility assurance
TRP Natural Eyes Aging Eye Relief eye drops are being recalled because the manufacturer cannot assure the product meets sterility requirements. The recall affects 19,344 bottles distributed nationwide.
Product
TRP Natural Eyes Aging 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 # 17312-027-15.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0374-2024·2024-03-20
FDA Recalls Betimol Eye Drops for Sterility and Container Closure Defects
Thea Pharma is recalling Betimol (timolol) ophthalmic solution nationwide for lack of sterility assurance and compromised container closure. The defects could allow contamination of the eye medication.
Product
BETIMOL — BETIMOL (TIMOLOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0372-2024·2024-03-20
Infuvite Adult Multiple Vitamins Injection Recalled for Storage Deviation
Baxter Healthcare's Infuvite Adult Multiple Vitamins Injection is being recalled because 70 vials were stored outside their labeled specifications, potentially affecting product stability. The affected vials were distributed to three direct accounts in Arizona, New Mexico, and Utah.
Product
Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
Category
Drug
Distribution
3 states
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

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