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.

2001–2025 of 2384

  • SevereFDA (Drugs)·D-0208-2015·2014-11-12

    FDA Recalls Compounded Omnipaque Injectable Due to Sterility Concerns

    Oregon Compounding Centers is recalling compounded Omnipaque injectable vials due to quality control issues affecting sterility assurance.

    Product
    OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0044-2015·2014-10-29

    Hospira Recalls Hydromorphone Hydrochloride Injection Due to Broken Vials

    Hospira Inc. is recalling 145,600 vials of Hydromorphone Hydrochloride Injection because customer complaints confirmed that some glass vials may be broken or cracked, compromising sterility.

    Product
    HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0004-2015·2014-10-08

    Baxter Recalls Dopamine Hydrochloride Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 11,808 bags of Dopamine Hydrochloride and Dextrose due to a potential manufacturing defect that may compromise sterility.

    Product
    DOPAMINE HYDROCHLORIDE AND DEXTROSE — DOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1615-2014·2014-10-08

    Sagent Recalls Zoledronic Acid Injection Due to Sterility Concerns

    Sagent Pharmaceuticals is recalling 10,622 bags of Zoledronic Acid Injection because of a lack of assurance of sterility and leaking premix bags.

    Product
    ZOLEDRONIC ACID — ZOLEDRONIC ACID (ZOLEDRONIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1587-2014·2014-09-24

    Unique Pharmaceutical Recalls Repinephrine IV Bags Due to Sterility Concerns

    Unique Pharmaceutical is recalling 430 bags of Repinephrine 4 mg in 250 mL Sodium Chloride 0.9% because a mold-like substance was found on an unopened bag during production.

    Product
    NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1583-2014·2014-09-17

    Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns

    Baxter Healthcare is recalling 157,080 containers of 0.9% Sodium Chloride Injection due to complaints of mold in the overpouch, raising concerns about sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1555-2014·2014-08-27

    Healix Recalls Fentanyl Infusion Bags Due to Sterility Concerns

    Healix Infusion Therapy is recalling compounded fentanyl infusion bags distributed in Texas and Georgia because the supplier recalled the source fentanyl due to loose or missing vial crimps.

    Product
    fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale, Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, S
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1553-2014·2014-08-27

    Healix Recalls Fentanyl and Ropivacaine Infusion Bags Due to Sterility Concerns

    Healix Infusion Therapy is recalling 12 bags of compounded fentanyl and ropivacaine due to a lack of assurance of sterility from a supplier recall.

    Product
    fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc., at 866-299-4826,
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1551-2014·2014-08-27

    Healix Recalls Fentanyl Syringes Due to Sterility Concerns

    Healix Infusion Therapy is recalling 50 fentanyl syringes because the supplier recalled the drug due to loose or missing vial crimps, raising sterility concerns.

    Product
    fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1552-2014·2014-08-27

    Healix Recalls Fentanyl Infusion Bags Due to Sterility Concerns

    Healix Infusion Therapy is recalling 48 bags of compounded fentanyl in Texas and Georgia because the supplier recalled the source drug due to loose or missing vial crimps.

    Product
    fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Su
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1543-2014·2014-08-27

    Ben Venue Recalls Cytarabine for Injection Due to Sterility Concerns

    Ben Venue Laboratories is recalling 7,172 vials of Cytarabine for Injection due to potential crimp defects that may affect sterility.

    Product
    CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories, Bedford, OH 44146, Manufactured by Ben Venue Labs, Inc., Bedford, OH 44146, NDC 55390-808-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1473-2014·2014-07-30

    Trinity Care Solutions Recalls Vancomycin Due to Sterility Concerns

    Trinity Care Solutions is recalling 14 units of Vancomycin 1.25 gm/250 mL due to lack of assurance of sterility identified during an FDA inspection.

    Product
    Vancomycin 1.25 gm/250 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29140, Discard After 05/23/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1467-2014·2014-07-30

    Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns

    Trinity Care Solutions is recalling compounded Cubicin 444 mg/100 mL due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Cubicin 444 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29114, Discard After 05/13/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1478-2014·2014-07-30

    Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns

    Trinity Care Solutions is recalling compounded Cubicin 700 mg/100 mL due to quality control concerns identified during an FDA inspection.

    Product
    Cubicin 700 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29083, Discard After 05/21/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1464-2014·2014-07-30

    Trinity Care Solutions Recalls Desferal Sterile Compounds Due to Sterility Concerns

    Trinity Care Solutions is recalling Desferal sterile compounds in Florida due to quality control concerns identified during an FDA inspection.

    Product
    Desferal 2 gm/8 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 27767, Discard After 05/23/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1479-2014·2014-07-30

    Trinity Care Solutions Recalls Cefepime Due to Sterility Concerns

    Trinity Care Solutions is recalling Cefepime 1 gm/100 mL 0.9%NS due to lack of assurance of sterility identified during an FDA inspection.

    Product
    Cefepime 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29011, Discard After 05/21/14, Rx # 29141, Discard After 05/22/14, Rx # 29171, Discard After 05/20/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1469-2014·2014-07-30

    Trinity Care Solutions Recalls Ambisome Due to Sterility Concerns

    Trinity Care Solutions is recalling Ambisome 285 mg/250 mL D5W in Florida due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Ambisome 285 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28300, Discard After 02/7/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1468-2014·2014-07-30

    Trinity Care Solutions Recalls Normal Saline Syringes Due to Sterility Concerns

    Trinity Care Solutions is recalling Normal Saline 10 mL syringes in Florida due to quality control concerns identified during an FDA inspection.

    Product
    Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28839, Discard After 05/5/15; Rx # 29163, Discard After 05/8/15
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1477-2014·2014-07-30

    Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns

    Trinity Care Solutions is recalling 8 units of compounded Cubicin 600 mg/100 mL due to quality control concerns regarding sterility assurance.

    Product
    Cubicin 600 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29096, Discard After 05/20/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1476-2014·2014-07-30

    Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns

    Trinity Care Solutions is recalling compounded Cubicin 543 mg/100 mL due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Cubicin 543 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29175, Discard After 05/21/14; Rx # 28830, Discard After 05/17/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1463-2014·2014-07-30

    Trinity Care Solutions Recalls Unasyn Due to Sterility Concerns

    Trinity Care Solutions is recalling 60 units of Unasyn (ampicillin/sulbactam) in Florida due to quality control concerns regarding sterility assurance.

    Product
    Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29082, Discard After 05/19/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1459-2014·2014-07-30

    Trinity Care Solutions Recalls Compounded Cubicin Due to Sterility Concerns

    Trinity Care Solutions is recalling 7 units of compounded Cubicin in Florida due to quality control concerns regarding sterility assurance identified during an FDA inspection.

    Product
    Cubicin 486 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, RX # 29038, Discard After 05/20/2014
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1461-2014·2014-07-30

    Trinity Care Solutions Recalls Meropenem Due to Sterility Concerns

    Trinity Care Solutions is recalling 42 units of Meropenem 1 gm/100 mL 0.9%NS due to lack of assurance of sterility identified during an FDA inspection.

    Product
    Meropenem 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29087, Discard After 05/28/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1453-2014·2014-07-30

    Trinity Care Solutions Recalls Levofloxacin Due to Sterility Concerns

    Trinity Care Solutions is recalling 7 units of compounded Levofloxacin 750 mg/250 mL D5W in Florida due to quality control concerns regarding sterility assurance.

    Product
    Levofloxacin 750 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #29184, Discard After 05/28/14
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1475-2014·2014-07-30

    Trinity Care Solutions Recalls Vancomycin Due to Sterility Concerns

    Trinity Care Solutions is recalling 14 units of Vancomycin 1.25 gm/100 mL 0.9%NS in Florida due to lack of assurance of sterility identified during an FDA inspection.

    Product
    Vancomycin 1.25 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29185, Discard After 05/23/14
    Category
    Drug
    Distribution
    1 state