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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4351–4375 of 8589

  • SevereFDA (Drugs)·D-0320-2017·2017-01-11

    Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 2 units of TriMix injection because the agency cannot assure the products are sterile.

    Product
    TriMix, Alprostadil/Phentolamine/Papaverine 100mcg/3mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0360-2017·2017-01-11

    Wells Pharmacy Recalls Injectable Compounds Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 199 vials of a compounded injectable product nationwide due to a lack of assurance of sterility.

    Product
    Glutamine/ORNI/ARGIN/LYSINE/LIDO Injectable, 75 mg/75 mg/150 mg/150 mg/10 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0373-2017·2017-01-11

    Wells Pharmacy Recalls MIC/B-COMP+LIDO Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable vials due to a lack of assurance of sterility.

    Product
    MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0422-2017·2017-01-11

    Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Testosterone Cypionate in Grapeseed Oil Injectable vials because the product lacks assurance of sterility.

    Product
    Testosterone Cypionate in Grapeseed Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0221-2017·2016-12-28

    FDA Recalls Black Gold X Advanced Capsules for Undeclared Sibutramine

    The FDA is recalling Black Gold X Advanced capsules because they contain undeclared sibutramine and were marketed without an approved NDA/ANDA.

    Product
    BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0218-2017·2016-12-28

    Hospira Recalls Bupivacaine Hydrochloride Vials Due to Particulate Matter

    Hospira Inc. is recalling 143,250 vials of Bupivacaine Hydrochloride Injection due to a confirmed report of particulate matter in a single vial.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0216-2017·2016-12-28

    Honeywell Eyesaline Eyewash Recalled for Klebsiella Pneumoniae Contamination

    Sperian Eye & Face Protection is recalling 9,744 bottles of Honeywell Eyesaline Eyewash Sterile Isotonic Solution due to non-sterility and contamination with Klebsiella pneumoniae.

    Product
    Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0211-2017·2016-12-28

    Guardian Pharmacy Recalls Lidocaine Syringes Due to Failed Sterility Test

    Guardian Pharmacy Services is recalling 180 pre-filled Lidocaine HCL/Sodium Bicarb syringes because a sterility test failed. The product was distributed to two medical facilities in Texas.

    Product
    Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0220-2017·2016-12-28

    FDA Recalls Black Label X Capsules for Undeclared Sildenafil

    Making It a Lifestyle is recalling 1,000 bottles of Black Label X capsules nationwide because they contain undeclared sildenafil and were marketed without FDA approval.

    Product
    BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0223-2017·2016-12-28

    Skinny Bee Diet capsules recalled for undeclared dangerous ingredients

    Love My Tru Body is recalling Skinny Bee Diet capsules because they contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein.

    Product
    Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0210-2017·2016-12-28

    Ultimate Body Tox PRO capsules recalled for undeclared sibutramine

    FDA is recalling Ultimate Body Tox PRO capsules because they contain undeclared sibutramine, a controlled substance removed from the market for safety reasons.

    Product
    Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0228-2017·2016-12-28

    Sermorelin/GHRP-6 Injection Recalled for Non-Sterility and Microbial Contamination

    Town and Country Compounding and Consultation Services is recalling Sermorelin/GHRP-6 Injection due to non-sterility and Bacillus circulans contamination.

    Product
    Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502
    Category
    Drug
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-0229-2017·2016-12-28

    Sage Products Recalls Comfort Shield Barrier Cream Cloths Due to Bacteria

    Sage Products LLC is recalling Comfort Shield Barrier Cream Cloths because they are contaminated with Burkholderia cepacia bacteria.

    Product
    COMFORT SHIELD BARRIER — COMFORT SHIELD BARRIER (DIMETHICONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0227-2017·2016-12-28

    Meta Pharmacy Recalls Compounded Eye Drops Due to Sterility Concerns

    Meta Pharmacy Services is recalling Phenylephrine and Tropicamide compounded eye drops due to a lack of sterility assurance. The affected product was distributed to one consignee in Las Vegas.

    Product
    Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile compounded drug, Hospital/office use only, Not for resale Storage: ROOM TEMP
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0217-2017·2016-12-28

    Novo Nordisk Recalls GlucaGen HypoKits Due to Detached Needles

    Novo Nordisk is recalling 71,215 GlucaGen HypoKits because the syringe needles may be detached. The recall covers lots expiring in September 2017.

    Product
    GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark, NDC 0169-7065-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0208-2017·2016-12-28

    Colonia Care Pharmacy Recalls Injectable Drug Products Due to Sterility Concerns

    Colonia Care Pharmacy is recalling C-PAV/PHENTOL/PGE1 injectable drug products due to lack of assurance of sterility. The recall affects products distributed in New Jersey and New York.

    Product
    C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0206-2017·2016-12-28

    Baxter Recalls Fluconazole Injection Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 30,910 bags of Fluconazole Injection due to confirmed customer complaints of leaking bags, which compromises sterility.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0209-2017·2016-12-28

    Colonia Care Pharmacy Recalls Injectable Drug Products Due to Sterility Concerns

    Colonia Care Pharmacy is recalling C-PAV/PHENTOL/ATROP/PGE1 injectable products due to lack of assurance of sterility. The recall affects products distributed in New Jersey and New York.

    Product
    C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0222-2017·2016-12-28

    3rd Degree Capsules Recalled for Undeclared Sibutramine

    Making It a Lifestyle is recalling 3rd Degree capsules because they contain undeclared sibutramine and were marketed without an approved NDA or ANDA.

    Product
    3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0215-2017·2016-12-28

    Impax Recalls Lamotrigine Tablets Due to Labeling Mixup

    Impax Laboratories is recalling 3,074 boxes of Lamotrigine Orally Disintegrating Tablets because some 200 mg boxes contained 100 mg tablets.

    Product
    Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0219-2017·2016-12-28

    US Compounding Recalls Docusate Oral Syringes Due to B. cepacia Contamination

    US Compounding Inc is recalling 10,665 Docusate Oral 10 mg/mL syringes distributed in Texas due to microbial contamination with B. cepacia.

    Product
    Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0226-2017·2016-12-28

    Amgen Recalls Kyprolis Vials Due to Potential Glass Cracks

    Amgen is recalling 11,434 vials of Kyprolis (carfilzomib) injection because potential cracks in the glass vials may compromise sterility.

    Product
    KYPROLIS — KYPROLIS (CARFILZOMIB)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0213-2017·2016-12-28

    Virtus Recalls Hyoscyamine Sulfate Tablets Due to Content Uniformity Failures

    Virtus Pharmaceuticals is recalling Hyoscyamine Sulfate tablets because they failed content uniformity specifications, resulting in both superpotent and subpotent doses.

    Product
    Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0212-2017·2016-12-28

    Virtus Recalls Hyoscyamine Sulfate Tablets Due to Content Uniformity Failures

    Virtus Pharmaceuticals is recalling Hyoscyamine Sulfate sublingual tablets because they failed content uniformity specifications, resulting in tablets that are either superpotent or subpotent.

    Product
    Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.
    Category
    Drug
    Distribution
    Distributed nationwide