The Recall Desk

Hazard

Lack Of Sterility recalls

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

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.

1–25 of 447

  • SevereFDA (Drugs)·D-0525-2026·2026-05-20

    Oasis Tears PF Lubricant Eye Drops Recalled for Sterility Assurance

    Oasis Medical, Inc. is recalling Oasis Tears PF preservative-free lubricant eye drops nationwide due to lack of assurance of sterility following FDA observations during an inspection.

    Product
    OASIS TEARS PF — OASIS TEARS PF (GLYCERIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0518-2026·2026-05-13

    BD PurPrep Povidone-Iodine Topical Solution Sterility Assurance Recall

    CareFusion 213, LLC is recalling BD PurPrep (povidone-iodine 8.3% with isopropyl alcohol 72.5%) due to lack of assurance of sterility and potential product contamination. Affected lots are distributed nationwide.

    Product
    PURPREP — PURPREP (POVIDONE IODINE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0491-2026·2026-05-06

    Systane Lubricant Eye Gel Recalled Due to Sterility Concerns

    Alcon Research LLC is recalling Systane Lubricant Eye Gel Night Gel (10g) distributed nationwide due to FDA inspection observations regarding lack of assurance of sterility that may impact product quality.

    Product
    SYSTANE — SYSTANE (HYPROMELLOSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0499-2026·2026-05-06

    Optase Dry Eye Drops Recalled for Lack of Sterility Assurance

    Scope Health is recalling Optase Dry Eye Intense Drops (Glycerin 0.2%) due to lack of assurance of sterility. The product is distributed nationwide.

    Product
    OPTASE — OPTASE (GLYCERIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0497-2026·2026-04-29

    Sodium Chloride for Irrigation Lacks Sterility Assurance

    B. Braun Medical Inc. is recalling sodium chloride for irrigation solution (3000 mL bags) due to lack of assurance of sterility and potential leakage from the diaphragm port. Affected lots distributed nationwide have expiration dates through May 31, 2028.

    Product
    SODIUM CHLORIDE FOR IRRIGATION — SODIUM CHLORIDE FOR IRRIGATION (SODIUM CHLORIDE FOR IRRIGATION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0495-2026·2026-04-29

    Sterile Water for Injection bags recalled due to sterility concerns

    B. Braun Medical Inc. is recalling Sterile Water for Injection USP 3000 mL bags (24,928 units) distributed nationwide due to lack of assurance of sterility and potential leakage from the diaphragm port.

    Product
    STERILE WATER — STERILE WATER (WATER)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0532-2026·2026-04-22

    Lidocaine Hydrochloride Injection Recalled Nationwide for Sterility Assurance Issues

    Lidocaine Hydrochloride injection vials are being recalled nationwide because manufacturers cannot guarantee the product's sterility. All lots within expiration are affected.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0483-2026·2026-04-22

    Epinephrine injection recalled for lack of sterility assurance

    International Medication Systems Ltd. is recalling epinephrine injection due to lack of assurance of sterility. The recall affects 81,520 units of lot EA038A5 distributed nationwide.

    Product
    EPINEPHRINE — EPINEPHRINE (EPINEPHRINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0530-2026·2026-04-22

    Bupivacaine Hydrochloride Injection Recalled for Lack of Sterility Assurance

    Bupivacaine Hydrochloride injectable anesthetic is being recalled due to lack of assurance of sterility. Approximately 3.26 million ampules distributed nationwide are affected.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0429-2026·2026-04-15

    Sodium chloride injection recalled by FDA for lack of sterility assurance

    Fresenius Kabi USA is recalling specific batches of 0.9% sodium chloride injection due to lack of assurance of sterility. The product is distributed nationwide, Alaska, and Puerto Rico.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0435-2026·2026-04-15

    Dextrose Injection Recalled for Lack of Sterility Assurance

    Fresenius Kabi is recalling 5% Dextrose Injection due to lack of assurance of sterility. The affected batch was distributed nationwide in the US, including Alaska and Puerto Rico.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0425-2026·2026-04-15

    Sodium Chloride IV Injection Recall for Sterility Assurance Concerns

    Fresenius Kabi recalled specific batches of 0.9% Sodium Chloride Injection due to lack of sterility assurance. Affected batches were distributed nationwide, Alaska, and Puerto Rico.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0424-2026·2026-04-15

    Sodium Chloride Injection Batch Recalled Due to Sterility Assurance

    Fresenius Kabi USA, LLC is recalling batch 6402413 of 0.45% Sodium Chloride Injection, USP, due to lack of assurance of sterility. The affected batch was distributed nationwide, including Alaska and Puerto Rico.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0433-2026·2026-04-15

    Sodium chloride intravenous injection recalled for lack of sterility assurance

    Fresenius Kabi USA, LLC is recalling multiple batches of 0.9% sodium chloride intravenous injection due to lack of sterility assurance. No illnesses have been reported, but non-sterile IV solutions pose a risk of serious infection.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0414-2026·2026-04-08

    Eye drops recalled for lack of sterility assurance

    K.C. Pharmaceuticals recalls multiple brands of over-the-counter eye drops nationwide due to lack of assurance of sterility. Approximately 315,144 bottles are affected.

    Product
    GNP EYE DROPS REDNESS AND DRY EYE RELIEF — GNP EYE DROPS REDNESS AND DRY EYE RELIEF (GLYCERIN, NAPHAZOLINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0407-2026·2026-03-25

    Prescription Eye Drops Recalled for Lack of Sterility Assurance

    Apotex Corp. is recalling brimonidine tartrate/timolol maleate ophthalmic solution nationwide due to lack of sterility assurance. The recall affects 107,136 vials across two lots.

    Product
    BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION — BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0395-2026·2026-03-11

    FDA Recalls Tirzepatide Injectables Due to Sterility Defect

    New Life Pharma LLC recalled 45 vials of Tirzepatide 15mg injectable due to lack of assurance of sterility. The affected lot was distributed in Ohio.

    Product
    Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0116-2026·2025-11-05

    Semaglutide Injection Vials Recalled Due to Sterility Concerns

    ProRx is recalling 8,310 vials of semaglutide injection due to lack of sterility assurance. The affected lots were distributed in Texas and Utah.

    Product
    Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0120-2026·2025-11-05

    Tirzepatide Injection Recalled for Lack of Sterility Assurance

    ProRx LLC is recalling 2,761 vials of Tirzepatide Injection due to lack of assurance of sterility. The affected lot was distributed to Texas and Utah.

    Product
    Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0058-2026·2025-10-15

    L-Glutamine for Injection Recalled Due to Lack of Sterility Assurance

    GenoGenix LLC is recalling all lots of L-Glutamine for Injection nationwide because the company cannot assure the product meets sterility requirements for safe injection.

    Product
    L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0086-2026·2025-10-15

    Injection Products Recalled for Lack of Sterility Assurance by GenoGenix

    BPC-157/Thymosin Beta-4 injections from GenoGenix are being recalled due to lack of assurance of sterility. The recall affects products distributed nationwide.

    Product
    BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute (MHI).
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0054-2026·2025-10-15

    GenoGenix Glycine for Injection Recalled for Lack of Sterility Assurance

    GenoGenix LLC is recalling all strengths of Glycine for Injection distributed nationwide due to lack of assurance of sterility. No illnesses have been reported.

    Product
    Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0064-2026·2025-10-15

    Injectable N-Acetyl-L-Cysteine Recalled Due to Sterility Assurance Failure

    GenoGenix, LLC is recalling all lots of N-Acetyl-L-Cysteine for Injection due to lack of assurance of sterility. All strengths and presentations distributed nationwide in the U.S. are affected.

    Product
    N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0073-2026·2025-10-15

    EDTA for Injection Recalled Due to Sterility Assurance Defect

    GenoGenix LLC is recalling all lots of EDTA for Injection nationwide due to lack of assurance of sterility, affecting all strengths and presentations.

    Product
    EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide