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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8226–8250 of 11823

  • SevereFDA (Drugs)·D-0264-2016·2015-11-25

    US Compounding Recalls Methylcobalamin Vials Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 265 vials of Methylcobalamin injection due to deficient practices that may impact sterility assurance.

    Product
    Methylcobalamin (12.5 mg/mL), 2.5 mL Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3251-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0276-2016·2015-11-25

    US Compounding Recalls Phenylephrine PF Syringes Due to Sterility Concerns

    US Compounding Inc is recalling 14,580 vials of Phenylephrine PF IV syringes nationwide due to deficient practices that may impact sterility assurance.

    Product
    Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3159-07
    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-299-2016·2015-11-25

    Essential Wellness Pharma Recalls 17-Alpha Hydroxyprogesterone Injections for Sterility Concerns

    Essential Wellness Pharma is recalling 17-Alpha Hydroxyprogesterone injections due to poor sterile production practices that compromised sterility assurance.

    Product
    17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0369-2016·2015-11-25

    Downing Labs Recalls DMSO 99% Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling DMSO 99% Injection vials because the product lacks assurance of sterility. The recall affects 187 vials distributed in the US and internationally.

    Product
    DMSO 99% Injection, 50mL 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-304-2016·2015-11-25

    Essential Wellness Pharma Recalls Dual Test Cyp/ena Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling Dual Test Cyp/ena Injection vials because poor sterile production practices resulted in a lack of sterility assurance.

    Product
    DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0366-2016·2015-11-25

    Downing Labs Recalls B12 Injection Due to Sterility Assurance Concerns

    Downing Labs, LLC is recalling 98 vials of B12 Injection 12.5/12.5MG due to a lack of assurance of sterility. The product was distributed nationwide and internationally.

    Product
    B12 Injection 12.5/12.5MG, 3mL, 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-0350-2016·2015-11-25

    Downing Labs Recalls Magnesium Sulfate Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling 320 vials of Magnesium Sulfate 50% Injectable because the company cannot assure the sterility of the product.

    Product
    Magnesium Sulfate 50% Injectable, 50mL 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
  • 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
  • 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
  • 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
  • SevereFDA (Drugs)·D-0209-2016·2015-11-18

    The Compounder Recalls Biest TD 83/17 Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 83/17 transdermal cream because the active ingredient was contaminated with penicillin. The recall is nationwide.

    Product
    BIEST TD 83/17 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) 1.2 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0188-2016·2015-11-18

    The Compounder Recalls Biest TD 50/50 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 50/50 transdermal cream because the active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

    Product
    BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 4.0 MG/ML transdermal cream packaged in 3mL syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0218-2016·2015-11-18

    FDA Recalls Compounder Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling specific lots of a compounded transdermal hormone cream because the active ingredient was contaminated with penicillin.

    Product
    ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosterone USP) W/V (weight/volume) 2 :0.1 : 30 : 0.5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0227-2016·2015-11-18

    The Compounder Recalls TRIEST 80/10/10 Capsules Due to Penicillin Contamination

    The Compounder is recalling TRIEST 80/10/10 capsules because the active ingredient was contaminated with penicillin. Patients should stop using the medication and consult a healthcare provider.

    Product
    TRIEST 80/10/10 (E1/E2 Trit - Estrone (E1)/Estradiol (E2) / Estriol USP (E3)) (23) 5MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0206-2016·2015-11-18

    The Compounder Recalls Biest TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) W/V (weight/volume) 1.25:100:0.625 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0191-2016·2015-11-18

    The Compounder Recalls Biest TD 80/20 Transdermal Cream Due to Penicillin Contamination

    The Compounder is recalling Biest TD 80/20 transdermal cream because the active ingredient was contaminated with penicillin. This recall affects nationwide distribution.

    Product
    BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0199-2016·2015-11-18

    The Compounder Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination

    The Compounder is recalling BIEST TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

    Product
    BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) 2.5 : 20 : 1.25 : 0.25 MG/ML TRANSDERMAL (Cream)Transdermal cream, dispensed in
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0220-2016·2015-11-18

    FDA Recalls Estradiol and Testosterone Cream Due to Penicillin Contamination

    The Compounder is recalling Estradiol and Testosterone transdermal cream because the active ingredient was contaminated with penicillin.

    Product
    ESTRIOL (E3) : TESTO (Testosterone USP) WV (weight/volume) 0.5MG : 2MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0171-2016·2015-11-18

    PGE 20mcg/ml Injection Recalled Due to Sterility Assurance Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PGE 20mcg/ml Injection vials due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    PGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0172-2016·2015-11-18

    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 identified GMP violations that may impact product sterility.

    Product
    PAPA/PGE1/PHENTO (30mg/50mcg/0.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0221-2016·2015-11-18

    The Compounder Recalls Estradiol Suppositories Due to Penicillin Contamination

    The Compounder is recalling Estradiol suppositories because the active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

    Product
    ESTRIOL (E3) 2.5MG suppositories, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0216-2016·2015-11-18

    The Compounder Recalls Estradiol and Progesterone Cream Due to Penicillin Contamination

    The Compounder is recalling Estradiol and Progesterone transdermal cream because the active ingredient was contaminated with penicillin.

    Product
    ESTRIOL (E3) : PROGESTERONE W/V (weight/volume) 4.0 : 100 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
    Category
    Drug
    Distribution
    Distributed nationwide