The Recall Desk

Hazard

Lack Of Sterility Assurance recalls

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

What the numbers show

Total
44
Critical
0
Severe
16
Most recent
2025-07-02

Of the 44 lack of sterility assurance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 16 (36%) 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 assurance 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.

26–44 of 44

  • HighFDA (Drugs)·D-0918-2022·2022-06-01

    Preserved ascorbic acid recalled due to lack of sterility assurance

    Olympia Compounding Pharmacy is recalling 7,420 vials of Preserved Ascorbic Acid due to lack of assurance of sterility. The injectable drug was distributed nationwide throughout the USA, Puerto Rico, and US Virgin Islands.

    Product
    Preserved Ascorbic Acid 500 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0079-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0944-2022·2022-06-01

    FDA Recalls Olympia Alprostadil 150 mcg/mL Injectable Vials for Sterility Concerns

    Olympia Compounding Pharmacy is recalling PGE-3 Alprostadil 150 mcg/mL multi-dose injectable vials nationwide due to lack of assurance of sterility. The recall involves 421 vials from lot L24508.

    Product
    PGE-3 Alprostadil 150 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0030-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0148-2022·2021-11-17

    Ultra-Test Injectable Compounded Drug Recalled for Lack of Sterility Assurance

    Talon Compounding Pharmacy is recalling Ultra-Test (CYP 80%/PROP 20%) 200mg/ml injectable across the United States, Puerto Rico, and Washington, D.C. due to lack of assurance of sterility.

    Product
    ULTRA-TEST (CYP 80%/PROP 20%) 200MG/ML INJ #1 200MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0102-2022·2021-11-17

    Alprostadil 30mcg/ml Injectable Recalled for Lack of Sterility Assurance

    Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Alprostadil 30mcg/ml injectable due to lack of assurance of sterility. The product was distributed in the United States including Washington, D.C. and Puerto Rico.

    Product
    ALPROSTADIL 30MCG/ML INJ 30MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0052-2022·2021-11-03

    Red Mountain Compounding Vitamin B Complex Injection Recall

    Red Mountain Compounding Pharmacy is recalling Vitamin B Complex Injection Solution because FDA inspection raised concerns about sterility assurance. Approximately 494 patients in seven states received the affected product.

    Product
    VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0034-2022·2021-11-03

    Cyclosporin 0.2% Oil Ophthalmic Suspension Recall Due to Sterility Assurance

    Red Mountain Compounding Pharmacy is recalling Cyclosporin 0.2% Oil Ophthalmic Suspension because FDA inspection identified concerns about sterility assurance. The recalled drug was distributed to approximately 494 patients across multiple states.

    Product
    CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-1089-2020·2020-04-15

    PharMEDium Recalls Fentanyl Citrate Injection Lots for Sterility Assurance Issues

    PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate injection products due to a lack of sterility assurance.

    Product
    fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1083-2020·2020-04-15

    PharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues

    PharMEDium Services is recalling 46 lots of rocuronium bromide syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.

    Product
    rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC 71019-321-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1087-2020·2020-04-15

    PharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues

    PharMEDium Services, LLC is recalling 46 lots of rocuronium bromide syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.

    Product
    rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-321-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1082-2020·2020-04-15

    PharMEDium Recalls nICARdipine HCl Injection Due to Sterility Assurance Concerns

    PharMEDium Services LLC is recalling 46 lots of nICARdipine HCl injection products because of a lack of sterility assurance.

    Product
    nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019-206-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1086-2020·2020-04-15

    PharMEDium Recalls Succinylcholine Chloride Syringes Due to Sterility Assurance Issues

    PharMEDium Services is recalling 46 lots of succinylcholine chloride syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.

    Product
    succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 71019-341-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1092-2020·2020-04-15

    PharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Concerns

    PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate injection products because of a lack of sterility assurance.

    Product
    fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road Dayton, NJ. NDC 61553-306-33
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1085-2020·2020-04-15

    PharMEDium Recalls Fentanyl Citrate Infusions Due to Sterility Assurance Issues

    PharMEDium Services, LLC is recalling 46 lots of fentanyl citrate infusions because of a lack of sterility assurance. The products were distributed nationwide in the US.

    Product
    fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0695-2020·2020-01-22

    Assurance Infusion Recalls BUP 21MG/CLON 252MCG/MORP 20MG/ML Injection Syringes

    Assurance Infusion is recalling BUP 21MG/CLON 252MCG/MORP 20MG/ML Injection syringes due to a lack of sterility assurance. The recall covers products distributed nationwide.

    Product
    BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1167-2019·2019-04-24

    Polyhexamethylene Biguanide Ophthalmic Drops Recalled for Sterility Assurance Issues

    Anderson Compounding Pharmacy is recalling Polyhexamethylene Biguanide 0.02% Ophthalmic Drops due to a lack of sterility assurance.

    Product
    Polyhexamethylene Biguanide 0.02% Ophthalmic Drops, 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1173-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Prostaglandin Tri-Mix Vials for Sterility Concerns

    Anderson Compounding Pharmacy is recalling 58 vials of Prostaglandin Tri-Mix 20:30:1 due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Prostaglandin Tri-Mix 20:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0437-2019·2019-02-20

    Promise Pharmacy Recalls Prednisolone and Bromfenac Ophthalmic Solution for Sterility Concerns

    Promise Pharmacy is recalling 167 bottles of compounded Prednisolone and Bromfenac Ophthalmic Solution due to a lack of sterility assurance.

    Product
    Prednisolone and Bromfenac Ophthalmic Solution, 1%/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-0441-2018·2018-02-28

    Pharmedium Recalls Ketamine HCl Injection Due to Sterility Assurance Concerns

    Pharmedium Services, LLC is recalling all lots of Ketamine HCl in 0.9% Sodium Chloride due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.

    Product
    Ketamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide