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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3901–3925 of 11819

  • SevereFDA (Drugs)·D-0791-2020·2020-01-29

    Mylan Recalls Nizatidine Capsules Due to NDMA Impurity Detection

    Mylan Pharmaceuticals is recalling Nizatidine Capsules 150 mg because trace amounts of the impurity NDMA were detected in the active ingredient.

    Product
    Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0800-2020·2020-01-29

    Entropic Labs SARM RAD-140 Recalled for Lack of FDA Approval

    Entropic Labs is recalling SARM RAD-140 capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0793-2020·2020-01-29

    Ranitidine Tablets Recalled Due to NDMA Impurity Detection

    H.J. Harkins Company is recalling specific lots of Ranitidine 150 mg tablets because NDMA impurity was detected. The product was distributed to physicians in four states.

    Product
    Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0792-2020·2020-01-29

    Mylan Recalls Nizatidine Capsules Due to NDMA Impurity Detection

    Mylan Pharmaceuticals is recalling Nizatidine Capsules 300 mg because trace amounts of the impurity NDMA were detected in the active ingredient.

    Product
    Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0797-2020·2020-01-29

    Preferred Pharmaceuticals Recalls Ranitidine Tablets Due to NDMA Impurity

    Preferred Pharmaceuticals is recalling Ranitidine Tablets, 300 mg, because the presence of the NDMA impurity was detected in the product.

    Product
    Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0)
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0794-2020·2020-01-29

    Denton Pharma Recalls Ranitidine Tablets Due to NDMA Impurity

    Denton Pharma is recalling 1,341 bottles of Ranitidine Tablets 150 mg because the product was found to contain the NDMA impurity.

    Product
    Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0655-2020·2020-01-22

    FDA Recalls Unapproved Stallion Platinum 30000 Capsules Containing Tadalafil

    Motto International Corp is recalling Stallion Platinum 30000 Capsules because FDA analysis found the unapproved product contains tadalafil.

    Product
    Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in hologram paper packaging, packaged in 2, 4, 10 count blister cards, Motto International, Dallas, TX
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0656-2020·2020-01-22

    FDA Recalls Rhino 7 Platinum 30000 Capsules for Unapproved Tadafila Content

    Motto International Corp is recalling Rhino 7 Platinum 30000 Capsules because FDA analysis found the product contains tadalafil, an unapproved active ingredient.

    Product
    Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,white,blue,gray text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0657-2020·2020-01-22

    FDA Recalls Panther Platinum 30000 Capsules for Unapproved Tadalfil Content

    Motto International Corp is recalling Panther Platinum 30000 Capsules because FDA analysis found the product contains tadalfil and was marketed without an approved NDA or ANDA.

    Product
    Panther Platinum 30000 Capsules, in green, black background with white, red text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0864-2020·2020-01-22

    Hikma Recalls Ketorolac Tromethamine Injection Due to Particulate Matter

    Hikma Pharmaceuticals is recalling specific lots of Ketorolac Tromethamine Injection because of the presence of polydimethylsiloxane particles.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0654-2020·2020-01-22

    FDA Recalls Unapproved Bull Platinum 30000 Capsules Containing Tadalafil

    Motto International Corp is recalling Bull Platinum 30000 Capsules because FDA analysis found the product contains tadalafil, a prescription drug, and it was marketed without an approved NDA or ANDA.

    Product
    Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, packaged in 2, 4 and 10 count blister cards, Motto International, Dallas, TX
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0673-2020·2020-01-22

    Assurance Infusion Recalls Multi-Drug Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of a multi-drug injection syringe due to a lack of sterility assurance.

    Product
    BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0664-2020·2020-01-22

    Assurance Infusion Recalls Multi-Drug Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of multi-drug injection syringes because of a lack of sterility assurance.

    Product
    BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj. in 20 mL syringe Assurance Infusion (713)533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0763-2020·2020-01-22

    Assurance Infusion Recalls QUADMIX Vials Due to Sterility Concerns

    Assurance Infusion is recalling QUADMIX in 1 mL vials because of a lack of sterility assurance. The affected lot was distributed nationwide.

    Product
    QUADMIX in 1 mL vial Assurance Infusion (713)-533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0740-2020·2020-01-22

    Assurance Infusion Recalls Hydromorphone Syringes Due to Sterility Concerns

    Assurance Infusion is recalling Hydromorphone 15mg/mL injection syringes due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    HYDROMORPHONE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0760-2020·2020-01-22

    Assurance Infusion Recalls Morphine Injection Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of Morphine 6mg/mL injection syringes due to a lack of sterility assurance. The products were distributed nationwide.

    Product
    MORPHINE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0736-2020·2020-01-22

    Assurance Infusion Recalls HCG Injections Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of HCG 3000U/1ML injections because they lack sterility assurance. The recall covers products distributed nationwide.

    Product
    HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0660-2020·2020-01-22

    Sun Pharma Recalls Sumatriptan Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling 207,585 blisters of Sumatriptan Succinate 100 mg tablets due to failed impurity specifications.

    Product
    Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0676-2020·2020-01-22

    Assurance Infusion Recalls Baclofen Syringes Due to Sterility Assurance Concerns

    Assurance Infusion is recalling specific lots of Baclofen injection syringes due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0765-2020·2020-01-22

    Assurance Infusion Recalls QUADMIX FORTE Vials Due to Sterility Concerns

    Assurance Infusion is recalling QUADMIX FORTE in 1 mL vials because of a lack of sterility assurance. The recall covers 5 vials distributed nationwide.

    Product
    QUADMIX FORTE in 1 mL vial Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0767-2020·2020-01-22

    Assurance Infusion Recalls Sufentanil Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific lots of Sufentanil 150mcg/mL injection syringes due to a lack of sterility assurance.

    Product
    SUFENTANIL 150MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0689-2020·2020-01-22

    Assurance Infusion Recalls Multi-Drug Injection Syringes Due to Sterility Concerns

    Assurance Infusion is recalling specific syringes of a multi-drug injection due to a lack of sterility assurance. The affected products were distributed nationwide.

    Product
    BUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0703-2020·2020-01-22

    Assurance Infusion Recalls BUP 35MG/FENT 1.5MG/ML Syringes for Sterility Concerns

    Assurance Infusion is recalling BUP 35MG/FENT 1.5MG/ML in 20 mL syringes due to a lack of sterility assurance. The affected lot was distributed nationwide.

    Product
    BUP 35MG/FENT 1.5MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide