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 the agency’s own highest classification or reported deaths or serious injuries, 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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12701–12725 of 17785

  • SevereFDA (Drugs)·D-0368-2016·2015-11-25

    Downing Labs Recalls L-Arginine Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling L-Arginine Injection, 100mg/mL, 30mL vials because the company cannot assure the sterility of the product.

    Product
    L-Arginine Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0246-2016·2015-11-25

    US Compounding Recalls Cyclopent/PE/Tropic Eye Drops Due to Sterility Concerns

    US Compounding Inc is recalling 820 bottles of Cyclopent/PE/Tropic eye drops because deficient practices may have compromised sterility assurance.

    Product
    Cyclopent/PE/Tropic 2mL (1%/2.5%/0.25%), 2 mL dropper bottles; For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0236-2016·2015-11-25

    US Compounding Recalls Acetylcysteine 10% Ophthalmic Solution for Sterility Concerns

    US Compounding Inc is recalling Acetylcysteine 10% Ophthalmic solution due to deficient practices that may impact sterility assurance.

    Product
    ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic use, Rx.only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-310-2016·2015-11-25

    Essential Wellness Recalls HCG Injection Vials Due to Sterility Concerns

    Essential Wellness Pharmacy is recalling HCG 5000 Units/mL injection vials because poor production practices raised concerns about the sterility of the compounded drugs.

    Product
    HCG 5000 Units/mL Injection, 0.4 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0279-2016·2015-11-25

    US Compounding Recalls Prednisolone Eye Drops Due to Sterility Concerns

    US Compounding Inc is recalling Prednisolone Sodium Phosphate eye drops due to deficient practices that may impact sterility assurance.

    Product
    Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For Topical Ophthalmic Use, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0360-2016·2015-11-25

    Downing Labs Recalls Magnesium Sulfate Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling 160 vials of Magnesium Sulfate Injectable because the company cannot assure the sterility of the product.

    Product
    Magnesium Sulfate Injectable, 14.28%, 7mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0259-2016·2015-11-25

    US Compounding Recalls Choline Chloride Inositol Cyanocobalamin Injection Vials

    US Compounding Inc is recalling 103 vials of a compounded injection due to deficient practices that may impact sterility assurance.

    Product
    Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3294-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0255-2016·2015-11-25

    US Compounding Recalls Hyaluronic Acid Syringes Due to Sterility Concerns

    US Compounding Inc is recalling 5,118 syringes of Hyaluronic Acid/Lidocaine PF due to deficient practices that may impact sterility assurance.

    Product
    Hyaluronic Acid/Lidocaine PF (20 mg/1%), 2 mL Single-Use Syringe , For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3087-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0372-2016·2015-11-25

    Downing Labs Recalls Piracetam Injection Due to Sterility Assurance Concerns

    Downing Labs, LLC is recalling Piracetam Injection, 200mg/mL, 10mL vials due to a lack of assurance of sterility. The recall covers all lots distributed nationwide and internationally.

    Product
    Piracetam Injection, 200mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-332-2016·2015-11-25

    Essential Wellness Pharma Recalls TRIMIX #1 Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling TRIMIX #1 Injection vials because poor production practices may have compromised the sterility of the compounded sterile preparations.

    Product
    TRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0292-2016·2015-11-25

    US Compounding Recalls Vitamin D3 Vials Due to Sterility Concerns

    US Compounding Inc is recalling 55 vials of Vitamin D3 in Olive Oil due to deficient practices that may impact sterility assurance.

    Product
    Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3277-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0256-2016·2015-11-25

    US Compounding Recalls Hyaluronic Acid Syringes Due to Sterility Concerns

    US Compounding Inc is recalling 531 hyaluronic acid and lidocaine syringes because deficient practices may have impacted sterility assurance.

    Product
    Hyaluronic Acid/Lidocaine PF (60 mg/2%), 3 mL Single Use Syringe, For Intra-Articular Injection , Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3249-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0365-2016·2015-11-25

    Downing Labs Recalls Hydroxocobalamin Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 106 vials of Hydroxocobalamin Injection due to a lack of assurance of sterility. The product was distributed nationwide and internationally.

    Product
    Hydroxocobalamin Injection (Buffered) 1mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0349-2016·2015-11-25

    Downing Labs Recalls Taurine Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling Taurine Injectable, 50mg/mL, 30mL vials due to a lack of assurance of sterility. The recall affects 123 vials distributed nationwide and internationally.

    Product
    Taurine Injectable, 50mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0262-2016·2015-11-25

    US Compounding Recalls Lincomycin/Lidocaine Vials Due to Sterility Concerns

    US Compounding Inc is recalling 1,421 vials of Lincomycin/Lidocaine due to deficient practices that may impact sterility assurance.

    Product
    Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection or IV Injection After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3104-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0232-2016·2015-11-25

    Qualitest Recalls Hydrochlorothiazide Capsules Due to Particulate Matter

    Vintage Pharmaceuticals is recalling 912 bottles of 12.5 mg Hydrochlorothiazide capsules because of the presence of particulate matter.

    Product
    HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, NDC: 0603-3855-93.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0234-2016·2015-11-25

    Par Pharmaceutical Recalls Meclizine Hydrochloride Tablets Due to Impurity Failures

    Par Pharmaceutical is recalling Meclizine Hydrochloride Tablets because they failed impurity specifications. The recall covers 100 and 1000-count bottles distributed nationwide.

    Product
    Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0235-2016·2015-11-25

    Mylan Recalls Meclizine Hydrochloride Tablets Due to Impurity Failures

    Mylan Institutional is recalling 4,609 packages of Meclizine Hydrochloride 25 mg tablets because they failed impurity specifications.

    Product
    Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0295-2016·2015-11-25

    Akorn Recalls Hydrocortisone Otic Solution Due to Missing Safety Seal

    Akorn, Inc. is recalling 13,896 bottles of Hydrocortisone and Acetic Acid Otic Solution because the bottles are missing the safety seal around the neck.

    Product
    Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0231-2016·2015-11-25

    Akorn Recalls RIFAMPIN FOR INJECTION Due to Impurity Specifications

    Akorn, Inc. is recalling 6,861 vials of RIFAMPIN FOR INJECTION USP, 600 mg because a known impurity failed to meet specifications.

    Product
    RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0233-2016·2015-11-25

    Par Pharmaceutical Recalls Meclizine Hydrochloride Tablets Due to Impurities

    Par Pharmaceutical is recalling specific lots of Meclizine Hydrochloride 12.5 mg tablets because they failed impurity specifications.

    Product
    Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0229-2016·2015-11-18

    Miracle Rock 48 capsules recalled for containing undeclared thiosildenafil

    The One Minute Miracle Inc. is recalling Miracle Rock 48 capsules because they contain undeclared thiosildenafil, an unapproved drug analogue.

    Product
    MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 0911312397354.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0230-2016·2015-11-18

    Miracle Diet 30 Recalled for Undeclared Phenolphthalein

    The One Minute Miracle Inc. is recalling Miracle Diet 30 capsules because they contain undeclared phenolphthalein, an unapproved drug ingredient.

    Product
    MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0179-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PGE1/PHENTO Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PGE1/PHENTO injection vials because an FDA inspection found GMP violations that may affect sterility.

    Product
    PAPA/PGE1/PHENTO (35mg/12mcg/1.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0212-2016·2015-11-18

    The Compounder Recalls Biest TD 91/9 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling specific lots of Biest TD 91/9 transdermal cream because the active ingredient was contaminated with penicillin.

    Product
    BIEST TD 91/9 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) : PROGESTERONE W/V (weight/volume) PLO (Pluronic F127 20% or Polox 20% gel) 3.3 MG/ML : 40 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall…
    Category
    Drug
    Distribution
    Distributed nationwide