The Recall Desk

Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,691
Critical
12
Severe
931
Most recent
2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) 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 failure 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.

1201–1225 of 1691

  • 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-0293-2016·2015-11-25

    US Compounding Recalls Voriconazole Eye Drops Due to Sterility Concerns

    US Compounding Inc is recalling specific lots of Voriconazole eye drops because deficient practices may have compromised sterility assurance.

    Product
    Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2815-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0253-2016·2015-11-25

    US Compounding Recalls Glycopyrrolate Syringes Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 14,325 syringes of Glycopyrrolate USP due to deficient practices that may impact sterility assurance.

    Product
    Glycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe, For IM or IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3082-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0244-2016·2015-11-25

    US Compounding Recalls Cyclo/PE/Trop PF Eye Drops for Sterility Concerns

    US Compounding Inc is recalling 135 bottles of Cyclo/PE/Trop PF eye drops nationwide due to deficient practices that may impact sterility assurance.

    Product
    Cyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottle, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3049-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0353-2016·2015-11-25

    Downing Labs Recalls Phosphatidylcholine Injection Due to Sterility Concerns

    Downing Labs is recalling specific lots of Phosphatidylcholine/Deoxycholic Acid Injection because the company cannot assure the product's sterility.

    Product
    Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/2.5%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/4.2%, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dalla
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-307-2016·2015-11-25

    FDA Recalls HCG and Lidocaine Injections Due to Sterility Concerns

    Kalman Health & Wellness is recalling HCG 1000 U/LIDO 0.2% Injection vials due to poor sterile production practices that compromised sterility assurance.

    Product
    HCG 1000 U/ LIDO 0.2%/mL Injection, packaged in a) 3 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-328-2016·2015-11-25

    Essential Wellness Pharma Recalls Testosterone Cypionate Injections Due to Sterility Concerns

    Essential Wellness Pharma is recalling 261 vials of Testosterone Cypionate 200 mcg/mL injection because poor sterile production practices resulted in a lack of sterility assurance.

    Product
    Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged 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-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-327-2016·2015-11-25

    Essential Wellness Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Essential Wellness Pharmacy is recalling Testosterone Cypionate 50 mg/mL injections due to poor sterile production practices that compromise sterility assurance.

    Product
    Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-315-2016·2015-11-25

    Essential Wellness Recalls Methylcobalamin Injections Due to Sterility Concerns

    Essential Wellness Pharmacy is recalling Methylcobalamin 5000 mcg/mL injections due to poor sterile production practices that compromised sterility assurance.

    Product
    Methylcobalamin 5000 mcg/mL Preservative Free Injection, packaged in a) 4 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0251-2016·2015-11-25

    US Compounding Recalls ePHEDrine Sulfate Syringes Due to Sterility Concerns

    US Compounding Inc is recalling 12,191 syringes of ePHEDrine Sulfate PF (50 mg/10 mL) nationwide due to deficient practices that may impact sterility assurance.

    Product
    ePHEDrine Sulfate PF (50 mg/10 mL), 10 mL Single-Use Syringe, For IV or IM Use Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3084-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0283-2016·2015-11-25

    US Compounding Recalls Trace Elements-4 IV Vials Due to Sterility Concerns

    US Compounding Inc is recalling 1,093 vials of Trace Elements-4 IV injection due to deficient practices that may impact sterility assurance.

    Product
    Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate 1.57 mg, Manganese Sulfate monohydrate USP 0.308 mg, Chromic Chloride hexahydrate USP 0.0205 mg), 10 mL Multi-Dose Vial, For IV Injection After Dilution, Dilute Before IV Use, Rx only, Compounded by
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-317-2016·2015-11-25

    Essential Wellness Recalls Methylcobalamin Syringes Due to Sterility Concerns

    Essential Wellness Pharmacy is recalling Methylcobalamin 25 mg/mL prefilled syringes due to poor sterile production practices that compromise sterility assurance.

    Product
    Methylcobalamin 25 mg/mL PF Injection, 0.5 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0267-2016·2015-11-25

    US Compounding Recalls Methylprednisolone/Lidocaine Vials Due to Sterility Concerns

    US Compounding Inc is recalling 11,363 vials of Methylprednisolone/Lidocaine due to deficient practices that may impact sterility assurance.

    Product
    Methylprednisolone/Lidocaine (40 mg/mL/1%) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3122-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-308-2016·2015-11-25

    FDA Recalls HCG Injection Vials Due to Sterility Concerns

    FDA is recalling HCG 2000 Units/mL Injection vials from Essential Wellness Pharmacy due to poor sterile production practices.

    Product
    HCG 2000 Units/mL Injection, packaged in a) 4 mL and b) 15 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-330-2016·2015-11-25

    Essential Wellness Pharma Recalls Testosterone Injection Vials Due to Sterility Concerns

    Kalman Health & Wellness is recalling 20 vials of Testosterone Injection due to poor sterile production practices that compromised sterility assurance.

    Product
    Testosterone CYP/ENAN/PROP Injection, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0252-2016·2015-11-25

    US Compounding Recalls Fentanyl Syringes Due to Sterility Assurance Concerns

    US Compounding Inc is recalling 711 fentanyl syringes nationwide because deficient practices may have impacted sterility assurance.

    Product
    Fentanyl PF 50 mL (25 mcg/mL), 10 mL Single Use Syringe, For IV, IM or SC injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0002-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0356-2016·2015-11-25

    Downing Labs Recalls Chromium Injectable Due to Sterility Assurance Concerns

    Downing Labs, LLC is recalling all lots of Chromium Injectable, 200mg/mL, 30mL vials because the product lacks assurance of sterility.

    Product
    Chromium Injectable, 200mg/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-319-2016·2015-11-25

    Essential Wellness Pharma Recalls MIC Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling MIC Injection vials because poor production practices may have compromised the sterility of the finished drugs.

    Product
    MIC Injection, 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-333-2016·2015-11-25

    Essential Wellness Pharma Recalls TRIMIX #2 Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling TRIMIX #2 Injection vials because poor sterile production practices resulted in a lack of sterility assurance for the finished drugs.

    Product
    TRIMIX #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0266-2016·2015-11-25

    US Compounding Recalls Methylprednisolone Vials Due to Sterility Concerns

    US Compounding Inc is recalling 22,627 vials of Methylprednisolone PF (80 mg/mL) because deficient practices may have impacted sterility assurance.

    Product
    MethylPREDNISolone PF (80 mg/mL), 1 mL Single Use Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3119-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0265-2016·2015-11-25

    US Compounding Recalls Methylprednisolone Vials Due to Sterility Concerns

    US Compounding Inc is recalling 3,629 vials of Methylprednisolone 100 mg/mL due to deficient practices that may impact sterility assurance.

    Product
    MethylPREDNISolone (100 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3115-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-322-2016·2015-11-25

    Essential Wellness Pharma Recalls Progesterone Injection Due to Sterility Concerns

    Essential Wellness Pharma is recalling specific lots of Progesterone 100 mg/mL Ethyl Oleate Injection due to poor sterile production practices that compromise sterility assurance.

    Product
    Progesterone 100 mg/mL Ethyl Oleate Injection, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0288-2016·2015-11-25

    Civco Biopsy Starter Kit Recalled Due to Sterility Concerns

    Civco Medical Instruments is recalling 1,139 boxes of Biopsy Starter Kits because the sterility of the product cannot be assured.

    Product
    CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047,
    Category
    Medical Device
    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