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.

1376–1400 of 2384

  • SevereFDA (Drugs)·D-0472-2016·2015-12-09

    Western Drug Recalls 17-Hydroxyprogesterone Injection Due to Sterility Concerns

    Western Drug is recalling 41 containers of 17-Hydroxyprogesterone 250mg/mL Injection because the product lacks assurance of sterility. The recall covers distribution in eight US states.

    Product
    17-Hydroxyprogesterone 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0429-2016·2015-12-09

    Western Drug Recalls Heparin Injection Due to Sterility Concerns

    Western Drug is recalling Heparin 1000 Unit/mL Injection because the product lacks assurance of sterility. The recall covers two containers distributed nationwide.

    Product
    Heparin 1000 Unit/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0463-2016·2015-12-09

    Western Drug Recalls Tri-Amino OAC Due to Sterility Concerns

    Western Drug is recalling 36 containers of Tri-Amino OAC 1:1:1 300mg/mL because the product lacks assurance of sterility.

    Product
    Tri-Amino OAC 1:1:1 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0476-2016·2015-12-09

    Western Drug Recalls Lipodissolve Injection Due to Sterility Concerns

    Western Drug is recalling Lipodissolve 100/50mg Injection Solution because the company cannot assure the product is sterile.

    Product
    Lipodissolve 100/50mg Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0481-2016·2015-12-09

    Western Drug Recalls Triamcinolone and Lidocaine Injection Due to Sterility Concerns

    Western Drug is recalling 16 containers of Triamcin40/Lido5 mg/mL Sus due to a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Triamcin40/Lido5 mg/mL Sus, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0394-2016·2015-12-09

    Western Drug Recalls Prostin Injection Due to Sterility Concerns

    Western Drug is recalling Prostin Injection due to a lack of assurance of sterility. The recall covers 16 containers distributed nationwide.

    Product
    Prostin Injection 10 mcg/mL, 25 mcg/mL, 50 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0411-2016·2015-12-09

    Western Drug Recalls M-Cobalamin Injections Due to Sterility Concerns

    Western Drug is recalling M-Cobalamin (B12) injections because the FDA determined there is a lack of assurance of sterility. The recall affects 3 containers distributed nationwide.

    Product
    M-Cobalamin (B12) Injection 200 mcg, 2000mcg, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0413-2016·2015-12-09

    Western Drug Recalls Medroxyprogesterone Injection Due to Sterility Concerns

    Western Drug Inc. is recalling 17 containers of Medroxyprogesterone 150/LID 5 mg/mL Injection because the company cannot ensure the product is sterile.

    Product
    Medroxyprogesterone 150/LID 5 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0435-2016·2015-12-09

    Western Drug Recalls Magnesium Chloride Injection Due to Sterility Concerns

    Western Drug is recalling Magnesium Chloride Injection because the product lacks assurance of sterility. The recall covers two containers distributed nationwide.

    Product
    Magnesium Chloride Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0448-2016·2015-12-09

    Western Drug Recalls Quad Mix Injections Due to Sterility Concerns

    Western Drug is recalling 15 containers of Quad Mix Inj because the company cannot ensure the product is sterile.

    Product
    Quad Mix Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0407-2016·2015-12-09

    Western Drug Recalls Glutathione Injection Due to Sterility Concerns

    Western Drug is recalling Glutathione 200 mg/mL SVN Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    Glutathione 200 mg/mL SVN Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0455-2016·2015-12-09

    Western Drug Recalls T.C.A 30% Acid Solution Due to Sterility Concerns

    Western Drug is recalling T.C.A 30% Acid Solution because the product lacks assurance of sterility. The recall affects one container distributed nationwide.

    Product
    T.C.A 30% Acid Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0419-2016·2015-12-09

    Western Drug Recalls Cantharitus Multi-Mix Prep Due to Sterility Concerns

    Western Drug is recalling Cantharitus Multi-Mix Prep because the product lacks assurance of sterility. The recall affects all lots distributed nationwide.

    Product
    Cantharitus Multi-Mix Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0387-2016·2015-12-02

    Qualgen Recalls Testosterone Pellets Due to Sterility Assurance Concerns

    Qualgen is recalling 10,885 vials of compounded Testosterone USP pellets nationwide due to deficient practices that may impact sterility assurance.

    Product
    Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC 69761-137-01), 50 mg (NDC 69761-150-01), 87.5 mg (NDC: 69761-187-01), 100 mg (NDC 69761-110-01), 200 mg (NDC 69761-120-01), Rx only, Compounded by Qualgen, Edmond, O
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0290-2016·2015-11-25

    US Compounding Recalls Tropicamide and Phenylephrine Ophthalmic Drops

    US Compounding Inc is recalling 751 bottles of Tropicamide 1%/Phenylephrine 2.5% ophthalmic drops due to deficient practices that may impact sterility assurance.

    Product
    Tropicamide 1%/Phenylephrine 2.5% (tropicamide USP 10 mg/ phenylephrine HCL USP 25 mg), 10 mL Ophthalmic Dropper, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3214-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0382-2016·2015-11-25

    Downing Labs Recalls Thiotic Acid Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling Thiotic Acid Injection because the company cannot ensure the product is sterile. The recall affects 7 vials distributed in the US and 17 other countries.

    Product
    Thiotic Acid Injection, 25mg/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-0337-2016·2015-11-25

    Downing Labs Recalls L-Glutamine Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling L-Glutamine Injectable vials because the company cannot assure the product's sterility. The recall covers all lots distributed in the US and internationally.

    Product
    L-Glutamine Injectable, 30mg/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-0284-2016·2015-11-25

    US Compounding Recalls Triamcinolone Acetonide Vials Due to Sterility Concerns

    US Compounding Inc is recalling 1,244 vials of compounded Triamcinolone acetonide due to deficient practices that may impact sterility assurance.

    Product
    Triamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3203-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0354-2016·2015-11-25

    Downing Labs Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling 186 vials of Methylcobalamin Buffered Injectable because the company cannot ensure the product is sterile.

    Product
    Methylcobalamin Buffered Injectable, 5mg/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-0241-2016·2015-11-25

    US Compounding Recalls Betamethasone Vials Due to Sterility Concerns

    US Compounding Inc is recalling 6,008 vials of Betamethasone SP PF due to deficient practices that may impact sterility assurance.

    Product
    Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3016-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0245-2016·2015-11-25

    US Compounding Recalls Cyclo/PE/Tropic/Ketor Ophthalmic Drops for Sterility Concerns

    US Compounding Inc is recalling 1,198 bottles of compounded ophthalmic drops nationwide due to deficient practices that may impact sterility assurance.

    Product
    Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For topical ophthalmic use, Rx. only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3044-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0338-2016·2015-11-25

    Downing Labs Recalls L-Tyrosine Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling 29 vials of L-Tyrosine Injectable because the product lacks assurance of sterility. The affected product was distributed nationwide and in multiple international markets.

    Product
    L-Tyrosine Injectable, 25mg/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-0345-2016·2015-11-25

    Downing Labs Recalls Procaine Injectables Due to Sterility Concerns

    Downing Labs, LLC is recalling 881 vials of Procaine Injectables because the company cannot ensure the product is sterile. The affected vials were distributed in the US and 17 other countries.

    Product
    Procaine Injectables 20mg/mL and 2%, 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-0364-2016·2015-11-25

    Downing Labs Recalls Sermorelin Injection Due to Sterility Concerns

    Downing Labs, LLC is recalling 287 vials of Sermorelin/GHRP-6/GHRP-2 Injection due to a lack of assurance of sterility. The product was distributed nationwide and in multiple international locations.

    Product
    Sermorelin/GHRP-6/GHRP-2 Injection 3MG/3MG/3MG, 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-0351-2016·2015-11-25

    Downing Labs Recalls Cyanocobalamin Injectable Due to Sterility Concerns

    Downing Labs, LLC is recalling Cyanocobalamin Buffered Injectable 3mg/mL vials because the company cannot ensure the product is sterile.

    Product
    Cyanocobalamin Buffered Injectable 3mg/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