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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5026–5050 of 5062

  • ModerateFDA (Drugs)·D-0650-2021·2021-07-14

    Genentech Xolair Injection Recalled for Failed Stability Specifications

    Genentech is recalling two lots of Xolair (omalizumab) injection nationwide due to out-of-specification Polysorbate 20 content detected at the 12-month stability testing timepoint. The affected lots are 3352758 and 3352759, both with August 2021 expiration dates.

    Product
    XOLAIR — XOLAIR (OMALIZUMAB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0651-2021·2021-07-14

    Xylocaine Lidocaine Injection Recalled for Low Epinephrine Assay Results

    Fresenius Kabi USA LLC is recalling Xylocaine-MPF with Epinephrine 1:200,000 injection vials nationwide due to low out-of-specification results for epinephrine assay.

    Product
    XYLOCAINE — XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0642-2021·2021-07-07

    Ginseng Power 5000 Capsules Recalled for Undeclared Prescription Drug Ingredients

    NSNY Distributor Inc is recalling Ginseng Power 5000 capsules nationwide because they contain undeclared sildenafil and/or tadalafil, prescription medications not listed on the label or approved for sale in this product.

    Product
    Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010, UPC 0 40232 18144 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0641-2021·2021-07-07

    Premium OrgaZEN 7000 Capsules Recalled for Undeclared Sildenafil and Tadalafil

    Premium OrgaZEN 7000 capsules distributed nationwide have been recalled because they were marketed without FDA approval and contain undeclared sildenafil and/or tadalafil, prescription drugs that pose serious health risks.

    Product
    Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 32555 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0645-2021·2021-07-07

    DiBAR LABS Hand Sanitizer Recalled for Methanol Contamination

    DiBAR LABS Hand Sanitizer (70% ethyl alcohol) in 16 FL OZ and 8 FL OZ bottles is being recalled nationwide because other lots and products made under the same conditions were found to contain methanol.

    Product
    DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) 16 FL OZ (473.1 mL) bottle, NDC 73009-001-16, UPC 8 53090 00302 0 and b) 8 FL OZ (236.5 mL) bottle, NDC 73009-0001-08, UPC 8 53090 00301 3; Distributed by: S.E.N.D, LLC., Anthony, NM 88021; Imported by: Dibar Labs, L
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0647-2021·2021-07-07

    Advance Hand Sanitizer Recalled for Methanol Contamination

    Dibar Labs is recalling Advance Hand Sanitizer (70% ethyl alcohol, 16 FL OZ) distributed nationwide because it was manufactured under the same conditions as lots found to contain methanol.

    Product
    ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by: Dibar Labs, LLC,.Sugar Land, TX 77479, Distributed by: Lifetime Health Services, Pharr, TX 78577, Made in Mexico, NDC; 79284-005-00. UPC 8 60004 06470 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0644-2021·2021-07-07

    DiBAR LABS Hand Sanitizer Recalled for Methanol Contamination

    DiBAR LABS Hand Sanitizer (ethyl alcohol 70%, 8 FL OZ) is being recalled because FDA testing found three lots contain methanol contamination and have ethanol content below the label claim.

    Product
    DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distributed by S.E.N.D. LLC, Anthony, NM 88021, Imported by Dibar Labs, LLC, Sugar Land, TX 77479, Made in Mexico,77479, NDC 73009-0001-08 UPC 8 53090 00301 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0646-2021·2021-07-07

    ProtectoRx Ethyl Alcohol 70% Hand Sanitizer Recalled for Methanol Contamination

    ProtectoRx hand sanitizer (ethyl alcohol 70%) is being recalled nationwide because some lots were found to contain methanol and all lots were manufactured under the same conditions as the contaminated product.

    Product
    ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002-01 and b) 16 FL OZ (473.2 mL), NDC 75408-002-02 bottles, Imported by: Dibar Labs, LLC., Sugar Land, TX 77479; Distributed by: PR Trading LLC, PO Box 19647, San Juan, PR 00910, Made in Mexico.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0643-2021·2021-07-07

    QiYu Hand Sanitizer Recalled for Subpotent Ethyl Alcohol Content

    HoYu (US) Logistics Inc is recalling QiYu Hand Sanitizer (75% ethyl alcohol) because the product is subpotent. The recall affects 30,880 bottles distributed nationwide.

    Product
    QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun District, Guanzhou, China Distributed by HoYu (US) Logistics Inc UPC 6 926645 716288
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0634-2021·2021-06-30

    PremierZEN Platinum 8000 Capsules Recalled for Undeclared Drug Ingredients

    PremierZEN Platinum 8000 capsules, distributed nationwide, are being recalled because the product contains undeclared pharmaceutical ingredients (Sildenafil and Tadalafil) and was marketed without FDA approval.

    Product
    PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0635-2021·2021-06-30

    maXXzen Platinum 12000 Capsule Recalled for Undisclosed Drug Contaminants

    The FDA is recalling maXXzen Platinum 12000 capsules distributed nationwide because the product was marketed without an approved application and contains undisclosed pharmaceutical ingredients (Sildenafil and Tadalafil).

    Product
    maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0633-2021·2021-06-30

    PremierZEN Gold 7000 Capsule Recalled for Undisclosed Drug Contamination

    PremierZEN Gold 7000 capsules are recalled nationwide because the product contains undisclosed pharmaceutical ingredients Sildenafil and Tadalafil and was marketed without FDA approval.

    Product
    PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0637-2021·2021-06-30

    DermOtic fluocinolone acetonide ear drops recalled for broken glass risk

    Hill Dermaceuticals is recalling DermOtic (fluocinolone acetonide) ear drops due to the potential for broken glass in the glass pipette dropper. The affected product was distributed nationwide.

    Product
    DERMOTIC — DERMOTIC (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0640-2021·2021-06-30

    Metformin Hydrochloride Tablets Recalled for NDMA Contamination

    Viona Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg due to detection of N-Nitrosodimethylamine (NDMA) levels exceeding acceptable daily intake limits.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0636-2021·2021-06-30

    Diflorasone Diacetate Ointment recalled for foreign particles

    Teligent Pharma is recalling Diflorasone Diacetate Ointment USP 0.05% due to the presence of foreign particles found during routine stability testing. The recall affects 6,240 tubes distributed nationwide.

    Product
    Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0638-2021·2021-06-30

    Mephyton Phytonadione 5 mg Tablets Recall for Failed Impurity Specifications

    Bausch Health Companies is recalling Mephyton (Phytonadione) 5 mg tablets nationwide because certain lots failed impurities and degradation specifications. Affected consumers should contact their healthcare provider.

    Product
    Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, 08807, USA, NDC 0187-1704-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0639-2021·2021-06-30

    Phytonadione 5 mg Tablets Recalled for Failed Impurity Specifications

    Bausch Health Companies is recalling Phytonadione 5 mg tablets distributed nationwide because the affected lots failed to meet impurity and degradation specifications. Consumers should consult their healthcare provider before stopping this medication.

    Product
    Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA, NDC 68682-170-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0628-2021·2021-06-23

    Imperia Elita Vitaccino Coffee Recalled for Unapproved Drug Ingredients

    Imperia Elita Vitaccino Coffee sachets are being recalled because they were marketed without FDA approval and contain pharmaceutical ingredients Sibutramine and Fluoxetine. All lots distributed nationwide are affected.

    Product
    Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technologies, Manufactured for: Imperia-Elita Ltd. & Co, KG D- 35435 Wettenberg
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0629-2021·2021-06-23

    Dr. Reddy's Atorvastatin Calcium Tablets Recalled for Failed Impurity Specifications

    Dr. Reddy's Laboratories is recalling Atorvastatin Calcium Tablets USP 10 mg nationwide because certain lots contain impurities that exceeded acceptable specifications.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0632-2021·2021-06-23

    QiYu Hand Sanitizer Gel recalled for subpotency

    World Source LLC is recalling QiYu Hand Sanitizer Gel (500 mL bottles) distributed to two hospitals in New York because the product is subpotent—meaning it contains less active ingredient than specified.

    Product
    QiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzhou Minghui Cosmetics Co., Ltd., Baiyun District, Guanzhou
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0648-2021·2021-06-23

    Ketamine HCl Injection Solution Recalled for Labeling and Expiration Date Errors

    Prisma Health Outsourcing Facility is recalling Ketamine HCl Injection Solution (10 mg / 2 mL) distributed in South Carolina due to incorrect expiration dates and incorrect Beyond Use Dates (BUD) on the labeling.

    Product
    Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded by Prisma Health Outsourcing Facility 1071 Holland Rd. Suite 2 Simpsonville, SC 29681. NDC: 73463-0100-01
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0631-2021·2021-06-23

    Phytonadione Tablets 5 mg Recalled Due to Failed Impurities Specification

    AVKARE Inc. is recalling Phytonadione Tablets 5 mg because the impurity degradant D level failed to meet specification. The affected lot was distributed in Los Angeles, California.

    Product
    Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0603-2021·2021-06-16

    Sodium Chloride 0.9% USP 1000 mL Recall for Temperature Abuse

    Fresenius Medical Care is recalling Sodium Chloride 0.9% USP 1000 mL injection (Lot #20NG02095, expiration October 2021) because the product was exposed to temperatures outside specified limits, which may affect its sterility and safety.

    Product
    Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0604-2021·2021-06-16

    DELFLEX Peritoneal Dialysis Solution Recall for Temperature Exposure

    Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose (5000 mL bags, 2-pack) due to temperature abuse during storage or transport that may have compromised product integrity.

    Product
    DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0624-2021·2021-06-16

    READYPREP CHG Chlorhexidine Gluconate Cloth recalled for superpotency

    Medline Industries is recalling READYPREP CHG 2% Chlorhexidine Gluconate Cloth because the product contains higher-than-specified levels of the active ingredient.

    Product
    READYPREP CHG — READYPREP CHG (CHLORHEXIDINE GLUCONATE 2%)
    Category
    Drug
    Distribution
    Distributed nationwide