The Recall Desk

Hazard

Sterility recalls

2,384 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,384
Critical
1
Severe
2,114
Most recent
2026-09-09

Of the 2,384 sterility recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,114 (89%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1401–1425 of 2384

  • SevereFDA (Drugs)·D-0341-2016·2015-11-25

    Downing Labs Recalls Acetyl-L-Carnitine Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling Acetyl-L-Carnitine and L-Carnitine injectable vials due to a lack of assurance of sterility. The products were distributed nationwide and internationally.

    Product
    Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500mg/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-0281-2016·2015-11-25

    US Compounding Recalls Testosterone Cypionate Vials Due to Sterility Concerns

    US Compounding Inc is recalling 2,524 vials of Testosterone cypionate, USP due to deficient practices that may impact sterility assurance.

    Product
    Testosterone cypionate, USP (250 mg/mL), 10 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2131-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0272-2016·2015-11-25

    US Compounding Recalls Omnipaque 300 Vials Due to Sterility Concerns

    US Compounding Inc is recalling 8,218 vials of Omnipaque 300 injection due to deficient practices that may impact sterility assurance.

    Product
    Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3137-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-312-2016·2015-11-25

    Essential Wellness Pharma Recalls LIPO B Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling 76 vials of LIPO B Injection because poor production practices created a lack of sterility assurance.

    Product
    LIPO B Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0376-2016·2015-11-25

    Downing Labs Recalls M.I.C Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling M.I.C Injection (Preserved) because the company cannot ensure the product is sterile. The recall affects 172 vials distributed in the US and internationally.

    Product
    M.I.C Injection (Preserved), 25/50/25mg/mL, 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-0285-2016·2015-11-25

    US Compounding Recalls Triamcinolone/Lidocaine Vials Due to Sterility Concerns

    US Compounding Inc is recalling 980 vials of compounded Triamcinolone/Lidocaine due to deficient practices that may impact sterility assurance.

    Product
    Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3204-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0286-2016·2015-11-25

    US Compounding Recalls Triamcinolone Diacetate Vials Due to Sterility Concerns

    US Compounding Inc is recalling 13,843 vials of Triamcinolone diacetate USP (40 mg/mL) nationwide due to deficient practices that may impact sterility assurance.

    Product
    Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3205-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0289-2016·2015-11-25

    US Compounding Recalls Tropicamide and Phenylephrine Eye Drops for Sterility Concerns

    US Compounding Inc is recalling 1,833 bottles of Tropicamide 0.5%/Phenylephrine 5% eye drops nationwide due to deficient practices that may impact sterility assurance.

    Product
    Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3298-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0370-2016·2015-11-25

    Downing Labs Recalls L-Glutathione Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 467 vials of L-Glutathione Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide and internationally.

    Product
    L-Glutathione Injection, 200mg/mL, 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-0280-2016·2015-11-25

    US Compounding Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns

    US Compounding Inc is recalling 1,590 syringes of Succinylcholine Chloride because deficient practices may have impacted sterility assurance.

    Product
    Succinylcholine Chloride (200 mg/10 mL), 10 mL Single Use Syringe (20 mg/mL), For IV use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3292-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0273-2016·2015-11-25

    US Compounding Recalls Phenylephrine and Lidocaine Vials Due to Sterility Concerns

    US Compounding Inc is recalling 542 vials of Phenylephrine 1.5%/Lidocaine 1% for intracameral injection due to deficient practices that may impact sterility assurance.

    Product
    Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3155-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0257-2016·2015-11-25

    US Compounding Recalls Hyaluronic Acid Syringes Due to Sterility Concerns

    US Compounding Inc is recalling 105 syringes of Hyaluronic Acid/Lidocaine due to deficient practices that may impact sterility assurance.

    Product
    Hyaluronic Acid/Lidocaine (20 mg/1%/2 mL), 3 mL Single Use Syringe, For Intra-Articular Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01
    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-0358-2016·2015-11-25

    Downing Labs Recalls TNPRDC Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 171 vials of TNPRDC Injection because the company cannot assure the sterility of the product. The recall covers all lots distributed nationwide and internationally.

    Product
    TNPRDC Injection, 6 mL 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-0269-2016·2015-11-25

    US Compounding Recalls MIC-Combo Vials Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 1,736 vials of MIC-Combo injection due to deficient practices that may impact sterility assurance.

    Product
    MIC-Combo, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3127-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0238-2016·2015-11-25

    US Compounding Recalls Betamethasone Vials Due to Sterility Concerns

    US Compounding Inc is recalling 19,494 vials of Betamethasone Combo 10 mL due to deficient practices that may impact sterility assurance.

    Product
    Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0379-2016·2015-11-25

    Downing Labs Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 34 vials of Testosterone Cypionate Injection due to a lack of assurance of sterility. The product was distributed nationwide and internationally.

    Product
    Testosterone Cypionate Injection (Sesame Oil), 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-0340-2016·2015-11-25

    Downing Labs Recalls EDTA Disodium Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling EDTA Disodium Injectable vials because the company cannot ensure the product is sterile.

    Product
    EDTA Disodium Injectable, 150mg/mL, 100mL 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-0378-2016·2015-11-25

    Downing Labs Recalls Thiamine HCl Injection Due to Sterility Concerns

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

    Product
    Thiamine HCl 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-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-0355-2016·2015-11-25

    Downing Labs Recalls HCG Injectable Due to Sterility Assurance Concerns

    Downing Labs, LLC is recalling 1,062 vials of HCG (Lyophilized) Injectable because the product lacks assurance of sterility. The recall covers all lots distributed nationwide and internationally.

    Product
    HCG (Lyophilized) Injectable, 5000 units/vial, 5mL 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-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-0363-2016·2015-11-25

    Downing Labs Recalls Calcium Gluconate Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 286 vials of Calcium Gluconate Injection 10% because the company cannot ensure the product is sterile.

    Product
    Calcium Gluconate (680mOsm/L) Injection 10%, 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-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