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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4901–4925 of 5062

  • LowFDA (Drugs)·D-0785-2021·2021-09-08

    Lidocaine Ointment USP 5% Recalled for Failed Viscosity Specifications

    Teligent Pharma is recalling Lidocaine Ointment USP 5% (114,456 tubes, Lots 15378 and 14418) distributed nationwide because certain lots do not meet viscosity specifications, as determined through routine testing.

    Product
    Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0784-2021·2021-09-08

    Donepezil HCL Tablets 5 mg Recalled for Subpotency

    Jubilant Cadista Pharmaceuticals is recalling Donepezil HCL Tablets, USP, 5 mg (Lot # DN120006A, exp. 12/2021) because the tablets are subpotent—meaning they contain less active ingredient than specified. The recall affects 14,544 bottles distributed nationwide.

    Product
    Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0767-2021·2021-09-01

    SterRx Sodium Bicarbonate Injection Recalled for Non-Sterility

    SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection due to microbial contamination confirmed by third-party laboratory testing. The affected product is a prescription intravenous injection distributed nationwide.

    Product
    Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0772-2021·2021-09-01

    Atovaquone Oral Suspension Recalled for Temperature Abuse

    KVK-Tech, Inc. is recalling Atovaquone Oral Suspension due to temperature abuse that caused unusual grittiness in the product. The defect may affect the medication's quality and safety.

    Product
    ATOVAQUONE ORAL SUSPENSION — ATOVAQUONE ORAL SUSPENSION (ATOVAQUONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0773-2021·2021-09-01

    Trulicity autoinjector pens recalled for incorrect strength labeling

    Eli Lilly & Company is recalling Trulicity (dulaglutide) 0.75 mg autoinjector pens because some contain double the labeled strength. Affected patients may receive an incorrect dose.

    Product
    TRULICITY — TRULICITY (DULAGLUTIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0765-2021·2021-09-01

    Fludarabine Phosphate Injection Recalled Due to Sterility Concern

    Custopharm, Inc. is recalling Fludarabine Phosphate for Injection, USP 50 mg because the manufacturer detected microbial contamination during environmental monitoring in aseptic manufacturing areas, raising sterility assurance concerns.

    Product
    FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0768-2021·2021-09-01

    SterRx Sodium Bicarbonate in 5% Dextrose Injection Recalled for Sterility Concerns

    SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection (1,000 mL bags) nationwide due to lack of assurance of sterility. Patients using affected lots should consult their healthcare provider immediately.

    Product
    Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0770-2021·2021-09-01

    Miss Slim capsules recalled for unapproved marketing distribution

    HIS ENTERPRISE INC is recalling all lots of Miss Slim capsules (10-count and 30-count boxes) distributed nationwide in the USA because the product was marketed without required FDA approval (ANDA/NDA).

    Product
    Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0755-2021·2021-09-01

    Pi yen chin Ophthalmic Redness Reliever Drops recalled due to sterility concerns

    Pi yen chin Ophthalmic Redness Reliever Drops are being recalled because they are actually manufactured as nasal drops and sterility cannot be assured. The product is labeled for ophthalmic use but does not meet the safety standards required for eye application.

    Product
    Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Chinese writing)International Nature Nutraceuticals, Inc. New York, NY 10002 www.INNHERB.com. Konzon NDC 51367-008-10
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0754-2021·2021-09-01

    Carvedilol 25 mg Tablets Recalled Due to Foreign Medication Contamination

    RemedyRepack Inc. is recalling Carvedilol 25 mg tablets after discovering that a 500-count source bottle contained two Paroxetine tablets (40 mg), which were then repackaged into 180-count bottles distributed to medical facilities in Virginia and Florida.

    Product
    Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0757-2021·2021-09-01

    Micafungin for Injection recalled for incomplete package insert

    Xellia Pharmaceuticals is recalling Micafungin for Injection due to an incomplete package insert that omits required sections on adverse reactions, drug interactions, and use in specific populations.

    Product
    Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0763-2021·2021-09-01

    PDI Povidone-Iodide Cleansing Scrub Swabstick Recall for Subpotency

    Professional Disposables International is recalling PDI Povidone-Iodide Cleansing Scrub Swabsticks distributed nationwide because the product is subpotent—meaning the active ingredient strength is below the required specification.

    Product
    PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0762-2021·2021-09-01

    PDI Povidone-Iodine Cleansing Scrub Swabstick Recalled for Subpotency

    Professional Disposables International is recalling PDI Povidone-Iodine Cleansing Scrub Swabsticks distributed nationwide because the product is subpotent—meaning it contains less active ingredient than specified.

    Product
    PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0756-2021·2021-09-01

    Micafungin for Injection Recalled for Incomplete Package Insert

    Xellia Pharmaceuticals USA is recalling Micafungin for Injection 50 mg/vial due to an incomplete package insert that omits required sections on Adverse Reactions, Drug Interactions, and Use in Specific Populations.

    Product
    Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-036-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0764-2021·2021-09-01

    PDI Duo-Swab Povidone-Iodine Cleansing Swabstick Recalled for Subpotency

    Professional Disposables International is recalling PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabsticks due to subpotency—the active ingredient is below the specified strength, which may reduce effectiveness for skin antisepsis.

    Product
    PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0759-2021·2021-09-01

    PDI Povidone-Iodine Prep Pads Recalled for Subpotent Active Ingredient

    Professional Disposables International is recalling PDI Povidone-Iodine Prep Pads distributed nationwide because the product is subpotent—the active ingredient falls below specification. Consumers should stop using affected lots and consult their healthcare provider.

    Product
    PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0761-2021·2021-09-01

    PDI Povidone-Iodine Swabstick Prep Pads Recalled for Subpotency

    Professional Disposables International is recalling PDI Povidone-Iodine Swabsticks nationwide because the product is subpotent—meaning the active ingredient is below the required specification.

    Product
    PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0766-2021·2021-09-01

    Sodium Phenylbutyrate Powder Recalled for Failed Impurities Specifications

    SigmaPharm Laboratories is recalling Sodium Phenylbutyrate powder nationwide due to out-of-specification impurity results found during routine testing. Affected bottles have specific lot numbers and expiration dates ranging from May 2023 to May 2024.

    Product
    SODIUM PHENYLBUTYRATE — SODIUM PHENYLBUTYRATE (SODIUM PHENYLBUTYRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0769-2021·2021-09-01

    Erythromycin Topical Solution Recalled for Defective Container Seal

    Teligent Pharma, Inc. is recalling Erythromycin Topical Solution USP 2% (60 mL bottles) due to defective containers that may lack seal integrity, potentially allowing contamination or leakage.

    Product
    Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0758-2021·2021-09-01

    PVP Iodine Prep Pads Recalled for Subpotent Active Ingredient

    Professional Disposables International is recalling PVP Iodine Prep Pads nationwide because the products are subpotent—containing less active ingredient than specified. The affected prep pads may not provide adequate antiseptic protection.

    Product
    PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0760-2021·2021-09-01

    PVP Iodine Prep Pads Recalled for Potency Below Specification

    Professional Disposables International is recalling PVP Iodine Prep Pads distributed nationwide because the product is subpotent—meaning the active ingredient strength falls below FDA specifications. Affected lots were distributed across the United States.

    Product
    PVP IODINE PREP PAD — PVP IODINE PREP PAD (PROVIDONE IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0771-2021·2021-09-01

    Bleomycin for Injection Recalled Due to Mislabeling

    Hikma Pharmaceuticals USA Inc. is recalling Bleomycin for Injection, USP due to mislabeling. The recall affects 1,152 vials distributed nationwide.

    Product
    BLEOMYCIN — BLEOMYCIN (BLEOMYCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0739-2021·2021-08-25

    Teva Norepinephrine Bitartrate Injection Recalled for Sterility Assurance

    Teva Pharmaceuticals USA is recalling Norepinephrine Bitartrate Injection, USP 4 mg/4 mL vials due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0731-2021·2021-08-25

    Methylprednisolone Acetate Injectable Suspension Recall: Sterility Assurance

    Teva Pharmaceuticals USA is recalling Methylprednisolone Acetate Injectable Suspension USP 40 mg/mL in single-dose and multi-dose vials nationwide due to lack of assurance of sterility.

    Product
    Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0736-2021·2021-08-25

    Teva Octreotide Acetate Injection Recalled for Sterility Assurance Failure

    Teva Pharmaceuticals is recalling Octreotide Acetate Injection 1000 mcg/5mL vials nationwide due to lack of assurance of sterility. The recall affects 16,644 vials distributed nationally.

    Product
    Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01
    Category
    Drug
    Distribution
    Distributed nationwide