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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10701–10725 of 18028

  • ModerateFDA (Drugs)·D-0900-2017·2017-06-21

    Safecor Health Recalls Acetaminophen Tablets Due to Manufacturing Deviations

    Safecor Health is recalling 66 bottles of Acetaminophen 325mg tablets due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot was distributed in Massachusetts and New York.

    Product
    Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904198280.
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Drugs)·D-0906-2017·2017-06-21

    Pharmedium Recalls 216 Bags of Potassium Chloride with Incorrect Volume Labeling

    Pharmedium Services, LLC is recalling 216 bags of Potassium Chloride in 0.9% Sodium Chloride because the product labels incorrectly state a volume of 115.00 mL instead of the actual 100.00 mL.

    Product
    Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0907-2017·2017-06-21

    Pharmedium Recalls Potassium Chloride Bags With Incorrect Volume Labeling

    Pharmedium Services, LLC is recalling 143 bags of Potassium Chloride in 0.9% Sodium Chloride because the product label incorrectly states the total volume as 105.00 mL instead of 100.00 mL.

    Product
    Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code 2K5856, NDC# 61553-0856-48, Total Volume 100.00 mL incorrectly labeled as 105.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0912-2017·2017-06-21

    Pharmedium Recalls Potassium Phosphate IV Bags Due to Labeling Error

    Pharmedium Services is recalling 48 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.

    Product
    Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service Code 2K5287, NDC# 61553-0287-48, Total Volume 100.00 mL incorrectly labeled as106.67 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0911-2017·2017-06-21

    Pharmedium Recalls Potassium Phosphate IV Bags Due to Incorrect Volume Labeling

    Pharmedium Services, LLC is recalling 672 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.

    Product
    Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code 2K5288, NDC# 61553-0288-48, Total Volume 100.00 mL incorrectly labeled as 103.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0910-2017·2017-06-21

    Pharmedium Recalls IV Bags With Incorrect Volume Labeling

    Pharmedium Services, LLC is recalling 912 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.

    Product
    Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Service Code 2K5295, NDC# 61553-0295-48, Total Volume 100.00 mL incorrectly labeled as105.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0913-2017·2017-06-21

    Pharmedium Recalls IV Bags with Incorrect Volume Labeling

    Pharmedium Services, LLC is recalling 216 bags of Potassium Phosphate in 0.9% Sodium Chloride because the total volume was incorrectly printed on the label.

    Product
    Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Code 2K5284, NDC# 61553-0284-48, Total Volume 100.00 mL incorrectly labeled as 102.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0909-2017·2017-06-21

    Pharmedium Recalls IV Bags With Incorrect Volume Labeling

    Pharmedium Services, LLC is recalling 192 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.

    Product
    Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service Code 2K5298, NDC# 61553-0298-48, Total Volume 100.00 mL incorrectly labeled as 102.50 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0920-2017·2017-06-21

    Mylan Recalls Montelukast Sodium Oral Granules Due to Impurity Failures

    Mylan Pharmaceuticals is recalling 11,624 pouches of Montelukast Sodium Oral Granules, 4 mg, due to failed impurity specifications.

    Product
    Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0882-2017·2017-06-14

    Spectrum Chemical Recalls Levonorgestrel API Due to CGMP Deviations

    Spectrum Laboratory Products is recalling levonorgestrel active pharmaceutical ingredient due to manufacturing deviations found by the FDA.

    Product
    Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code L1229.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0888-2017·2017-06-14

    MedPark Pharmacy Recalls Methylcobalamin Injection Vials Due to Sterility Concerns

    MedPark Pharmacy is recalling methylcobalamin 1mg/1mL injection vials because the company cannot ensure the product is sterile. The affected lot was distributed to a patient in Maryland.

    Product
    methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 Medical Pkwy. # 170 Annapolis, MD 21401
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0894-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 12.5 mg pellets due to CGMP deviations and a lack of quality assurance. The recall covers 4,883 pellets distributed nationwide.

    Product
    Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-012-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0890-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 22 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 1,666 pellets distributed nationwide.

    Product
    Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-022-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0892-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 18 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 6,361 pellets distributed nationwide.

    Product
    Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-018-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0885-2017·2017-06-14

    Dr. Reddy's Recalls Zenatane Isotretinoin Capsules for Dissolution Failures

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because some lots failed to meet dissolution specifications, potentially affecting drug absorption.

    Product
    ZENATANE — ZENATANE (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0893-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 15 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 6,227 units distributed nationwide.

    Product
    Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles. Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-015-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0891-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 20 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 4,468 pellets distributed nationwide.

    Product
    Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0886-2017·2017-06-14

    Dr. Reddy's Recalls Zenatane Capsules for Low Dissolution

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because some lots failed to meet dissolution specifications.

    Product
    ZENATANE — ZENATANE (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0896-2017·2017-06-14

    Qualgen Estradiol Pellets Recalled for Quality Assurance Deviations

    Qualgen is recalling Estradiol 6 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 4,815 pellets distributed nationwide.

    Product
    Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by; Qualgen 14844 Bristol Park Blvd. Edmond, OK 73013 NDC: 69761-006-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0881-2017·2017-06-14

    Spectrum Laboratory Estradiol API Recalled for CGMP Deviations

    Spectrum Laboratory Products is recalling Estradiol active pharmaceutical ingredient due to Good Manufacturing Practice deviations found during an FDA inspection.

    Product
    Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Pr
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0895-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 10 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 5,260 pellets distributed nationwide.

    Product
    Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only , For Subcutaneous Use Only Rx Only Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-010-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0883-2017·2017-06-14

    Dr. Reddy's Recalls Zenatane Isotretinoin Capsules for Dissolution Failures

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because some lots failed to meet dissolution specifications, potentially affecting drug absorption.

    Product
    ZENATANE — ZENATANE (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0889-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 25 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 1,153 pellets distributed nationwide.

    Product
    Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only. Rx Only ,Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-025-01,
    Category
    Drug
    Distribution
    Distributed nationwide