The Recall Desk

Hazard

Non Sterility recalls

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

What the numbers show

Total
145
Critical
85
Severe
55
Most recent
2026-07-01

Of the 145 non sterility recalls we have scored against our rubric, 85 (59%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 55 (38%) 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 non 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.

126–145 of 145

  • CriticalFDA (Drugs)·D-0251-2015·2014-11-26

    Abrams Royal Pharmacy Recalls Non-Sterile Lidocaine and Bupivacaine Syringes

    Abrams Royal Pharmacy is recalling 50 syringes of a compounded lidocaine and bupivacaine mixture due to non-sterility. The products were distributed in Texas.

    Product
    Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64 u/mL, supplied in 11 mL Sterile Syringes, Rx only, Compounded med, Single use only, (Red Block) ABRAMS ROYAL Compounding Pharmacy, Dallas, TX
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0250-2015·2014-11-26

    Abrams Royal Pharmacy Recalls Calcium Chloride Injection Due to Sterility Failures

    Abrams Royal Pharmacy is recalling 1,100 vials of Calcium Chloride Preservative Free Sterile Injection because contract testing found sterility failures.

    Product
    Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231.
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0230-2015·2014-11-05

    FDA Recalls Calcium Glucosate Injection Due to Microbial Contamination

    Specialty Compounding, LLC is recalling Calcium Gluconate 2 gm in 100 mL Sodium Chloride 0.9% for Injection due to non-sterility and microbial contamination.

    Product
    CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% for Injection, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0011-2015·2014-10-15

    Unique Pharmaceutical Recalls N-Acetyl Cysteine Vials Due to Non-Sterility

    Unique Pharmaceutical, Ltd is recalling one lot of N-Acetyl Cysteine 20% vials because testing revealed the presence of Herbaspirillum huttiense bacteria.

    Product
    N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1563-2014·2014-09-03

    Abrams Royal Pharmacy Recalls Non-Sterile Mineral IV Injection

    Abrams Royal Pharmacy is recalling 74 units of Mineral IV Injection found to contain Sphingomonas paucimobilis, indicating non-sterility.

    Product
    MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1546-2014·2014-08-27

    Pharmacy Creations Recalls Ascorbic Acid Injection Vials Due to Mold Contamination

    Pharmacy Creations is recalling 70 vials of Ascorbic Acid 500 mg/mL sterile injection due to mold contamination. The affected product was distributed in New York, New Jersey, and Puerto Rico.

    Product
    Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1354-2014·2014-06-04

    Teva Recalls ParaGard T 380A Intrauterine Contraceptives for Sterility Failure

    Teva Pharmaceuticals is recalling 47,890 units of ParaGard T 380A intrauterine contraceptives in New York and Kentucky due to a failed sterility test.

    Product
    ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1276-2014·2014-05-07

    Baxter Recalls Dianeal Peritoneal Dialysis Solution Due to Mold Contamination

    Baxter Healthcare is recalling 27,169 containers of Dianeal Low Calcium with Dextrose peritoneal dialysis solution due to reported leaks and mold contamination.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1252-2014·2014-04-30

    Glycopyrrolate Injectable Recalled for Bacillus thuringiensis Contamination

    Brookfield Prescription Center Inc. is recalling one lot of Glycopyrrolate solution for injection due to Bacillus thuringiensis contamination.

    Product
    Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/Sterile Syringes, for use by a licensed professional only, not for resale, MD Custom Rx, 19035 W Capitol Dr Ste 105, Brookfield, WI 53045.
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1156-2014·2014-03-19

    FDA Recalls Dextrose Vials Due to Mold Contamination

    Specialty Medicine Compounding Pharmacy is recalling 50% Dextrose vials after mold was found in the product. The recall affects 1,000 vials distributed in Michigan.

    Product
    Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-375-2014·2013-12-25

    Altaire Recalls Carboxymethylcellulose Sodium Eye Drops Due to Non-Sterility

    Altaire Pharmaceuticals is recalling specific lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution because the preservative may not be effective through expiry, posing a non-sterility risk.

    Product
    Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottle, sold under the following labels: (a) CVS pharmacy brand LUBRICANT EYE DROPS FOR MILD TO MODERATE DRY EYE, Distributed by CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 053357 7 and UPC 0 50428
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-810-2013·2013-07-31

    Med Prep Consulting Recalls Magnesium Sulfate Injection Bags Due to Mold

    Med Prep Consulting is recalling 403,883 bags of Magnesium Sulfate 2 grams in Dextrose 5% for Injection due to non-sterility and mold contamination.

    Product
    Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-321-2013·2013-05-22

    Green Valley Drugs Recalls Methylprednisolone Injectable Suspension Due to Sterility Failure

    Green Valley Drugs is recalling Methylprednisolone Preservative Free 40 mg/mL injectable suspension because testing revealed positive sterility results.

    Product
    Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension, 1 mL Vials and 2 mL Vials and 1 mL pre-filled syringes, For Office Use Only, Manufactured by Green Valley Drugs, Henderson, NV.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-322-2013·2013-05-22

    Green Valley Drugs Recalls Cyanocobalamin Injection Due to Sterility Failure

    Green Valley Drugs is recalling Cyanocobalamin 1000 mcg/mL injection because testing revealed positive sterility results.

    Product
    Cyanocobalamin 1000 mcg/ml, injection 30 mL, MDV, For Office Use Only, Green Valley Drugs, Manufactured by Green Valley Drugs, Henderson, NV.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-263-2013·2013-04-24

    Hospira Recalls Lactated Ringer's Injection Due to Non-Sterility

    Hospira is recalling Lactated Ringer's and 5% Dextrose Injection due to a confirmed report of non-sterility involving spore-like particulates consistent with mold.

    Product
    Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-110-2013·2013-01-09

    FDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility

    New England Compounding Center is recalling 5,130 vials of Methylprednisolone Acetate Injection nationwide due to non-sterility concerns.

    Product
    Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-108-2013·2013-01-09

    FDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility

    New England Compounding Center is recalling 23,897 vials of Methylprednisolone Acetate Injection nationwide due to non-sterility concerns.

    Product
    Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-109-2013·2013-01-09

    FDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility

    New England Compounding Center is recalling 9,062 vials of Methylprednisolone Acetate Injection because they may not be sterile. The recall is nationwide.

    Product
    Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-111-2013·2013-01-09

    FDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility

    New England Compounding Center is recalling 3,822 vials of Methylprednisolone Acetate 80 mg/mL Injection nationwide due to non-sterility concerns.

    Product
    Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide