The Recall Desk

Hazard

Lack Of Sterility recalls

1,423 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,423
Critical
3
Severe
1,055
Most recent
2026-10-14

Of the 1,423 lack of sterility recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,055 (74%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all lack of 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.

801–825 of 1423

  • SevereFDA (Drugs)·D-0457-2019·2019-02-20

    Promise Pharmacy Recalls Epithalon Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling Epithalon 15mg injections due to a lack of sterility assurance. The affected lots were distributed nationwide.

    Product
    Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0465-2019·2019-02-20

    Promise Pharmacy Recalls Melanotan II Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 43 vials of Melanotan II injections because the product lacks sterility assurance. The affected lots were distributed nationwide.

    Product
    Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0462-2019·2019-02-20

    Promise Pharmacy Recalls HCG Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 819 vials of HCG injections nationwide due to a lack of sterility assurance.

    Product
    HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0445-2019·2019-02-20

    Promise Pharmacy Recalls Glutathione Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling specific lots of Glutathione Injection because of a lack of sterility assurance. The affected products were distributed nationwide.

    Product
    Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0455-2019·2019-02-20

    Promise Pharmacy Recalls Ipamorelin Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 93 vials of Ipamorelin injections nationwide due to a lack of sterility assurance.

    Product
    Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0435-2019·2019-02-20

    Promise Pharmacy Recalls Prednisolone Ophthalmic Solution Due to Sterility Concerns

    Promise Pharmacy is recalling compounded Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution due to a lack of sterility assurance.

    Product
    Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0438-2019·2019-02-20

    Promise Pharmacy Recalls Vitamin B Complex Vials Due to Sterility Concerns

    Promise Pharmacy is recalling 204 vials of compounded Vitamin B Complex due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 mg/mL 10 mL vial, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists, 31818 US Hwy 19N, Palm Harbor FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0436-2019·2019-02-20

    Promise Pharmacy Recalls Prednisolone Ophthalmic Solution for Sterility Concerns

    Promise Pharmacy is recalling compounded Prednisolone and Gatifloxacin and Bromfenac ophthalmic solution due to lack of sterility assurance. The recall covers 900 bottles distributed nationwide.

    Product
    Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0478-2019·2019-02-20

    Promise Pharmacy Recalls Dexpanthenol Injection Vials Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 7 vials of Dexpanthenol Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0474-2019·2019-02-20

    Promise Pharmacy Recalls Procaine HCl Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 11 vials of Procaine HCl 2% injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0459-2019·2019-02-20

    Promise Pharmacy Recalls BPC 157 Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 37 vials of BPC 157 injections because they lack sterility assurance. The affected lot was distributed nationwide.

    Product
    BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0444-2019·2019-02-20

    Promise Pharmacy Recalls Amino Blend Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 158 vials of Amino Blend Injection because the product lacks sterility assurance. The recall covers lots distributed nationwide.

    Product
    Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0450-2019·2019-02-20

    Promise Pharmacy Recalls Sermorelin Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 341 vials of Sermorelin/GHRP2/GHRP6 injection because the product lacks sterility assurance. The recall covers lots distributed nationwide in the USA.

    Product
    Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0431-2019·2019-02-20

    Promise Pharmacy Recalls Acetylcysteine Ophthalmic Solution Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 75 bottles of Acetylcysteine Ophthalmic Solution because the product lacks sterility assurance. The recall covers nationwide distribution in the USA.

    Product
    Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0460-2019·2019-02-20

    Promise Pharmacy Recalls HCG Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 654 vials of HCG injections nationwide due to a lack of sterility assurance.

    Product
    HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0454-2019·2019-02-20

    Promise Pharmacy Recalls Ipamorelin and Sermorelin Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 139 vials of Ipamorelin and Sermorelin injections nationwide due to a lack of sterility assurance.

    Product
    Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0443-2019·2019-02-20

    Promise Pharmacy Recalls Methylcobalamin Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 704 vials of Methylcobalamin 10,000 mcg Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0453-2019·2019-02-20

    Promise Pharmacy Recalls Ipamorelin Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 416 vials of Ipamorelin 9 mg injection because the product lacks sterility assurance. The affected lots were distributed nationwide.

    Product
    Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0470-2019·2019-02-20

    Promise Pharmacy Recalls Myer's Cocktail Vials Due to Sterility Concerns

    Promise Pharmacy is recalling 5 vials of Myer's Cocktail due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6/Vit B1/Leucine/Vit B5/Riboflavin/Ascorbic Acid/Hydroxycobalamin/Magnesium Chloride, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0434-2019·2019-02-20

    Promise Pharmacy Recalls Prednisolone and Gatifloxacin Ophthalmic Solution for Sterility Concerns

    Promise Pharmacy is recalling compounded Prednisolone and Gatifloxacin ophthalmic solution due to a lack of sterility assurance.

    Product
    Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo Drops: 3 mL Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0433-2019·2019-02-20

    Promise Pharmacy Recalls Prednisolone and Gatifloxacin Eye Drops for Sterility Concerns

    Promise Pharmacy is recalling 55 bottles of compounded Prednisolone and Gatifloxacin Ophthalmic Solution due to a lack of sterility assurance.

    Product
    Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0472-2019·2019-02-20

    Promise Pharmacy Recalls Folic Acid Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling Folic Acid Injection, 10 mg/mL, 10mL vials due to a lack of sterility assurance. The affected lots were distributed nationwide.

    Product
    Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0456-2019·2019-02-20

    Promise Pharmacy Recalls IGF-1 LR3 Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 59 vials of IGF-1 LR3 injections because they lack sterility assurance. The affected products were distributed nationwide.

    Product
    IGF-1 LR3, 620 mcg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0475-2019·2019-02-20

    Promise Pharmacy Recalls Pyridoxine HCl Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 8 vials of Pyridoxine HCl Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0422-2019·2019-02-06

    BromSite Ophthalmic Solution Recalled for Lack of Sterility Assurance

    Sun Pharmaceutical is recalling BromSite (bromfenac) 0.075% ophthalmic solution due to a lack of sterility assurance. The recall affects 69,840 bottles distributed nationwide.

    Product
    BROMSITE — BROMSITE (BROMFENAC)
    Category
    Drug
    Distribution
    Distributed nationwide