The Recall Desk

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.

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3551–3575 of 17964

  • HighFDA (Drugs)·D-1354-2022·2022-08-24

    Injectable ketorolac tromethamine recalled nationwide for potential cross-contamination

    Nephron Pharmaceuticals is recalling Ketorolac Tromethamine Injection due to manufacturing deviations that could lead to cross-contamination. The recall affects 5,040 vials distributed nationwide.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1355-2022·2022-08-24

    Avant Foaming Hand Sanitizer Recalled Due to Manufacturing Process Deviation

    Aire-Master of America Inc. is recalling Avant Foaming Hand Sanitizer because the deionized water system used in manufacturing lacked appropriate microbial control measures.

    Product
    Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-1361-2022·2022-08-24

    PrednisoLONE Oral Solution Recalled for Defective Container Seals

    Akorn, Inc. is recalling 14,712 bottles of PrednisoLONE Oral Solution (15 mg/5 mL) due to incomplete induction seals in containers. No illnesses have been reported, but the defect may affect product integrity.

    Product
    PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1347-2022·2022-08-24

    Labetalol HCl Injection Recalled for Manufacturing Cross-Contamination Risk

    Nephron Sterile Compounding Center is recalling PF-Labetalol HCl Injection nationwide due to manufacturing deviations that create potential for cross-contamination. No illnesses have been reported.

    Product
    PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1344-2022·2022-08-24

    FDA Recalls Neostigmine Methylsulfate Injectable Due to Contamination Risk

    Nephron Sterile Compounding Center is recalling one lot of Neostigmine Methylsulfate Injection due to potential cross-contamination from product carryover during manufacturing. The recall affects 13,500 vials distributed nationwide.

    Product
    PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1348-2022·2022-08-24

    Acetaminophen Injection Recalled for Temperature Storage Abuse Nationwide

    Baxter Healthcare recalls 85,680 bags of acetaminophen injection nationwide due to temperature abuse in distribution. Product was shipped in refrigerated trucks despite being labeled for room temperature storage.

    Product
    ACETAMINOPHEN — ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1356-2022·2022-08-24

    Avant Foaming Hand Sanitizer recalled due to manufacturing process deviation

    Aire-Master of America is recalling Avant Foaming Hand Sanitizer due to a manufacturing process deviation where the deionized water system lacked proper microbial controls during production.

    Product
    Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-1345-2022·2022-08-24

    IV Trisodium Citrate Solution Recalled for Potential Cross-Contamination Risk

    Nephron Sterile Compounding Center is recalling 294 bags of Trisodium Citrate 0.5% Solution IV bags due to potential cross-contamination from manufacturing deviations. The affected lots were distributed nationwide.

    Product
    Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 6937
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1359-2022·2022-08-24

    Foaming Hand Sanitizer Recalled for Water System Manufacturing Deficiency

    Protect U Guard Foaming Hand Sanitizer is being recalled because it was manufactured with deionized water from a system lacking proper microbial controls. The affected product was distributed in Florida, Illinois, Iowa, and New Jersey.

    Product
    Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-1351-2022·2022-08-24

    Prescription cancer drug lot recalled for failed quality specifications

    Zydus Pharmaceuticals recalls Fulvestrant Injection lot B200076 due to failed purity and stability specifications. Distributed nationwide; expiration January 31, 2024.

    Product
    FULVESTRANT — FULVESTRANT (FULVESTRANT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1343-2022·2022-08-24

    Rifampin Capsules Recalled Due to Manufacturing Control Deviation

    Lupin Pharmaceuticals is recalling Rifampin 150 mg capsules (lot #A200170) nationwide due to a Current Good Manufacturing Practice deviation with an out-of-specification impurity detected during manufacturing.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1357-2022·2022-08-24

    Stage 2-Ophardt Foaming Hand Sanitizer Recalled Due to Microbial Control Deviation

    Aire-Master of America Inc is recalling 4,632 cartons of Stage 2-Ophardt Foaming Hand Sanitizer due to manufacturing deviations in the water system's microbial control. Product was distributed in Florida, Illinois, Iowa, and New Jersey.

    Product
    Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1353-2022·2022-08-24

    Akorn Pharma recalls Acetaminophen 500 mg tablets with missing imprints

    Akorn Pharma, Inc. is recalling Acetaminophen 500 mg Extra Strength tablets because the imprint identification marking is missing from the tablets. The recall affects 30,325 bottles distributed to wholesalers.

    Product
    Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1352-2022·2022-08-24

    Acetaminophen 325 mg tablets recalled for missing imprint

    Akorn Pharma is recalling 301,382 bottles of Acetaminophen 325 mg tablets because the tablets lack the required "AP 325" imprint marking.

    Product
    Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1349-2022·2022-08-24

    Azacitidine for Injection Recalled Nationwide for Subpotent Dosage

    Amerisource Health Services is recalling 4,160 vials of Azacitidine for Injection nationwide due to subpotency. The affected vials may contain less than the labeled 100 mg of active ingredient.

    Product
    Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1358-2022·2022-08-24

    Hand Sanitizer Recalled for Manufacturing Process Deficiency

    Protect U Guard Foaming Hand Sanitizer is being recalled due to a manufacturing deficiency in the deionized water system. The product was distributed in Florida, Illinois, Iowa, and New Jersey.

    Product
    Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1335-2022·2022-08-24

    Drug Recall: Incorrect Syringe in ZYNRELEF Anesthetic Delivery Kits

    Heron Therapeutics is recalling 1,790 kits of ZYNRELEF (bupivacaine and meloxicam) distributed nationwide because one lot contains an incorrect syringe in the delivery system. No illnesses or injuries have been reported.

    Product
    ZYNRELEF — ZYNRELEF (BUPIVACAINE AND MELOXICAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1328-2022·2022-08-17

    Difluprednate eye drops recalled for defective container closure affecting sterility

    Cipla is recalling Difluprednate ophthalmic emulsion nationwide due to defective container closures that compromise sterility assurance. Patients using the affected lot should discontinue use and contact their healthcare provider.

    Product
    DIFLUPREDNATE — DIFLUPREDNATE (DIFLUPREDNATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1317-2022·2022-08-17

    FDA Recalls ZADITOR Eye Drops Due to Improper Storage Conditions

    ZADITOR eye drops were stored outside FDA label specifications in a nationwide Class II recall affecting 9 boxes distributed by McKesson Medical-Surgical Inc.

    Product
    ZADITOR — ZADITOR (KETOTIFEN FUMARATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1331-2022·2022-08-17

    FentaNYL Citrate IV solution recalled due to sterility assurance concerns

    SterRx is recalling FentaNYL Citrate intravenous bags (10 mcg/mL) due to lack of assurance of sterility. The recalled lot (CHI, expiring December 2022) was distributed nationwide.

    Product
    FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1313-2022·2022-08-17

    Eye Drops Recalled Due to Improper Storage Violating Manufacturing Standards

    Naphcon A eye drops are being recalled nationwide because products were stored outside label specifications, violating Current Good Manufacturing Practice (CGMP) standards.

    Product
    NAPHCON A — NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1332-2022·2022-08-17

    Fentanyl Citrate IV Bags Recalled Due to Sterility Assurance Failure

    SterRx is recalling 360 bags of fentanyl citrate IV medication due to lack of assurance of sterility. No illnesses have been reported.

    Product
    fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1310-2022·2022-08-17

    Lorazepam Injection Recalled for Out-of-Specification Impurities and Degradation

    Hikma Pharmaceuticals is recalling 82,700 vials of Lorazepam Injection due to failed quality specifications for impurities and degradation. Lot #070096 (expired July 2023) was distributed nationwide.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1330-2022·2022-08-17

    Prednisone Tablets Recalled for Contamination With Wrong-Strength Tablets

    Strides Pharma is recalling Prednisone 20 mg tablets due to contamination with 2.5 mg tablets. No illnesses have been reported, but patients may receive incorrect doses.

    Product
    PREDNISONE — PREDNISONE (PREDNISONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1311-2022·2022-08-17

    Triple Antibiotic Ointment Recalled Due to Improper Storage

    McKesson Medical-Surgical Inc. is recalling Triple Antibiotic Ointment due to storage deviations that violated drug label specifications and current good manufacturing practices.

    Product
    Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibiotic Ointment, 144 packets per box, Net wt. per packet 0.5 g, Honeywell Safety Products, NDC 0498-0750-36.
    Category
    Drug
    Distribution
    Distributed nationwide