The Recall Desk

Hazard

Sterility Concern recalls

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

What the numbers show

Total
75
Critical
0
Severe
44
Most recent
2025-06-04

Of the 75 sterility concern recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 44 (59%) 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 concern 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.

51–75 of 75

  • SevereFDA (Drugs)·D-662-2013·2013-07-10

    Progesterone Injection Recalled Due to Sterility Concerns

    Clinical Specialties Compounding Pharmacy is recalling specific lots of Progesterone 50 mg/ml because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Progesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-563-2013·2013-06-12

    Compounded Ascorbic Acid Injectable Recalled for Sterility Concerns

    The Compounding Shop is recalling compounded Ascorbic Acid 500 mg/mL injectable vials due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-550-2013·2013-06-12

    Baclofen Injectable Recalled Due to Sterility Concerns

    The Compounding Shop is recalling Baclofen 500 mcg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-571-2013·2013-06-12

    Compounded MIC Injectable Recalled Due to Sterility Concerns

    The Compounding Shop is recalling MIC Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-549-2013·2013-06-12

    Avastin Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Shop is recalling Avastin injectable vials because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-561-2013·2013-06-12

    Methylcobalamin Injectable Recalled Due to Sterility Concerns

    The Compounding Shop is recalling Methylcobalamin 1,000 mcg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-566-2013·2013-06-12

    Compounded Injectable MIC Plus B12 Recalled Due to Sterility Concerns

    The Compounding Shop is recalling MIC + B12 injectable vials because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-570-2013·2013-06-12

    Praziquantel Vials Recalled Due to Sterility Concerns

    The Compounding Shop is recalling Praziquantel 56.8 mg vials because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-482-2013·2013-06-05

    Nora Apothecary Recalls Hydroxycobalamin Injection Due to Sterility Concerns

    Nora Apothecary and Alternative Therapies, Inc. is recalling Hydroxycobalamin Injection 2500 mcg/ml due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Hydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-490-2013·2013-06-05

    Gentamicin Irrigation Recalled Due to Sterility Assurance Concerns

    Nora Apothecary is recalling Gentamicin 24mg/60ml Irrigation because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-455-2013·2013-06-05

    Nora Apothecary Recalls Bimix Inj Penile Injection Due to Sterility Concerns

    Nora Apothecary is recalling Bimix Inj 30:1 MDV penile injections because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-465-2013·2013-06-05

    Nora Apothecary Recalls Trimix Penile Injections Due to Sterility Concerns

    Nora Apothecary is recalling Trimix penile injections because FDA inspections raised concerns about quality control and the assurance of sterility.

    Product
    Trimix Inj 4.25ml Form MDV Penile Injection, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-464-2013·2013-06-05

    Nora Apothecary Recalls Trimix Penile Injection Due to Sterility Concerns

    Nora Apothecary is recalling Trimix penile injections because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Trimix Inj 30:3:5 MDV, 10ml Penile Injection, 90 day expiration,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2290-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Needles Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical needles due to concerns about sterility. The affected lot is distributed nationwide.

    Product
    Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81) Length***Reorder: ESE1651***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to concerns regarding sterility. The affected products are intended for cutting and coagulation of soft tissue.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0" (10.16cm) Length***Reorder: ES0016A***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2294-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected lot is 052709-01.

    Product
    Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reorder: ES0009***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2292-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to concerns about sterility. The recall affects 1,920 units distributed nationwide.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (16.51cm) Length***Reorder: ES0014***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2291-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling specific lots of Medline electrosurgical electrodes due to concerns regarding sterility.

    Product
    Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2293-2012·2012-09-05

    Medline Electrosurgical Electrodes Recalled for Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units are intended for cutting and coagulation of soft tissue.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 4.0 (10.16cm) Length***Reorder: ES0014AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2289-2012·2012-09-05

    Medline PTFE Coated Needle Recall Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline Standard PTFE Coated Needles due to sterility concerns. The affected lots are distributed nationwide.

    Product
    Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reorder: ES0013***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of
    Category
    Medical Device
    Distribution
    Distributed nationwide