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

1601–1625 of 5047

ModerateFDA (Drugs)·D-0434-2024·2024-04-10
Cyclophosphamide Injection Recalled for Package Insert Concentration Labeling Error
X-Gen Pharmaceuticals recalls Cyclophosphamide for Injection due to a labeling error in the Package Insert. Section 2.3 incorrectly lists the concentration as '20 mg per vial' instead of the correct '20 mg per mL'.
Product
Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJ
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0433-2024·2024-04-10
Cyclophosphamide Injection Recalled for Package Insert Concentration Labeling Error
X-Gen Pharmaceuticals is recalling 1,283 vials of Cyclophosphamide for Injection due to a Package Insert error that lists concentration as '20 mg per vial' instead of '20 mg per mL'. No illnesses have been reported.
Product
Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0429-2024·2024-04-03
Treprostinil Injection recalled nationwide due to particulate matter contamination
Par Pharmaceutical is recalling Treprostinil Injection nationwide due to the presence of particulate matter. This FDA Class I recall affects 466 vials of lot 57014 distributed throughout the United States.
Product
Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0424-2024·2024-04-03
Succinylcholine Chloride Injection Recalled for Sterility Assurance Failure
SCA Pharmaceuticals is recalling 5,079 syringes of Succinylcholine Chloride Injection nationwide due to lack of sterility assurance. Affected lots are #1223049085 and #1223049364.
Product
SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-09, Bar Code 70004090809
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0418-2024·2024-04-03
Phenylephrine HCl Injectable Recalled Nationwide for Lack of Sterility Assurance
SCA Pharmaceuticals is recalling Phenylephrine HCl Injectable (400 mcg/10 mL) distributed nationwide due to lack of sterility assurance. Affected lot numbers have expiration dates through May 2024.
Product
PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0811-12, Bar Code 70004081112.
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-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-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-0412-2024·2024-04-03
Injectable midazolam HCl recalled due to sterility assurance failure
SCA Pharmaceuticals is recalling Midazolam HCl 100 mg/100 mL injectable nationwide because the manufacturer cannot assure sterility of the product. Users should consult their healthcare provider regarding affected lot numbers.
Product
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159
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
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-0394-2024·2024-04-03
Diltiazem HCl Injection Lacks Sterility Assurance; SCA Pharmaceuticals Recalls
SCA Pharmaceuticals is recalling Diltiazem HCl 125 mg Injectable (381 bags) due to lack of sterility assurance. Patients and healthcare providers should not use affected units from lot #1223049625.
Product
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0403-2024·2024-04-03
Fentanyl Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals recalls fentanyl injection syringes due to concerns about sterility. No illnesses have been reported, but patients and healthcare providers should check if they have products from the affected lot numbers, which expired in December 2023.
Product
fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, Bar code 70004020022,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0395-2024·2024-04-03
Fentanyl Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals recalls fentanyl 2,500 mcg/250 mL injection (548 bags) nationwide due to lack of assurance of sterility. The affected product may not meet pharmaceutical sterility standards required for injectable drugs.
Product
fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 BAR code 70004022940
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0404-2024·2024-04-03
FDA Recalls HYDROmorphone Injection Cassettes Due to Sterility Concerns
SCA Pharmaceuticals recalls 256 units of HYDROmorphone HCl injection in Grey CADD Cassettes nationwide due to lack of assured sterility. The affected lot is #1223049529 with expiration date 01/03/24.
Product
HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar Code 70004030063
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-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-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-0426-2024·2024-04-03
Divalproex Sodium 250 mg tablets recalled for failed dissolution specifications
Amneal Pharmaceuticals is recalling Divalproex Sodium Extended-release Tablets 250 mg nationwide due to failed dissolution specifications. The tablets may not dissolve properly, affecting medication effectiveness.
Product
DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
Category
Drug
Distribution
Distributed nationwide
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-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-0425-2024·2024-04-03
Vancomycin Injectable Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals is recalling 368 bags of vancomycin 1.25 g injectable nationwide because the company cannot assure sterility was maintained. The affected lot was distributed across the USA.
Product
VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359
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
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

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1601–1625 of 5047