The Recall Desk

Hazard

Infection Risk recalls

3,429 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,429
Critical
25
Severe
988
Most recent
2026-09-03

Of the 3,429 infection risk recalls we have scored against our rubric, 25 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 988 (29%) 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 infection risk 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.

3401–3425 of 3429

  • SevereFDA (Drugs)·D-1577-2012·2012-08-22

    Franck's Lab Recalls Sterile Metoclopramide Injectable Due to Contamination

    Franck's Lab Inc. is recalling sterile metoclopramide HCL injectable products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    METOCLOPRAMIDE HCL 5MG/ML (10MG/2ML) INJECTABLE 2 ML 20 ML 200 ML 394 ML 400 ML 498 ML 500 ML 6 ML 600 ML (9 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1519-2012·2012-08-22

    Franck's Lab Recalls Sterile Fluorescein/Indocyanine Drugs Due to Sterility Concerns

    Franck's Lab Inc. is recalling sterile Fluorescein/Indocyanine injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 VIAL, 24 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/15MG VIAL INJECTABLE 23 VIAL, 25 VIAL, 30 VIAL, 7 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/5MG VIAL INJECTABLE 1 VIAL, 10 VIAL, 12 VIAL, 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1599-2012·2012-08-22

    Franck's Lab Recalls Sterile Phenylephrine Injectable Drugs Due to Contamination

    Franck's Lab Inc. is recalling sterile phenylephrine injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    PHENYLEPHRINE HCL IN BSS - P.F. OPHTHALMIC 1% INJECTABLE 35 ML; PHENYLEPHRINE HCL, 1ML VIAL*** 1% (10MG/ML) INJECTABLE 1 ML 10 ML 25 ML 5 ML 50 ML; PHENYLEPHRINE, STSL, P.F. (0.5ML SYRINGE, SLIP-TIP, NO NEEDLE) 1.25% INJECTABLE 5 ML 7.5 ML (8 DIFFER
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1529-2012·2012-08-22

    Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile glutathione products distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the clean room.

    Product
    GLUTATHIONE INHALATION 30MG/ML SOLUTION 120 ML, 60 ML; GLUTATHIONE P.F. 200MG/ML INJECTABLE 10 ML, 100 ML, 14 ML, 150 ML, 175 ML, 20 ML, 30 ML, 300 ML, 40 ML, 40 MLS, 50 ML, 58 MLS, 70 ML; GLUTATHIONE P.F. 50MG/ML (500MG/10ML) INJECTABLE 100 ML, 150 ML, 20 ML, 40 ML, 60 ML;
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1479-2012·2012-08-22

    Franck's Lab Recalls Sterile Bupivacaine/Sufentanil Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile bupivacaine/sufentanil injections because FDA sampling found microorganisms and fungal growth in the production clean room.

    Product
    BUPIVACAINE/SUFENTANIL, P.F. 15MG/150MCG/ML INTRATHECAL 20 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1608-2012·2012-08-22

    Franck's Lab Recalls Sterile Progesterone Injections Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile progesterone injections distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the production clean room.

    Product
    PROGESTERONE AQUEOUS 2MG/ML INJECTABLE 3 ML; PROGESTERONE IN COTTONSEED OIL 50MG/ML INJECTABLE 30 ML; PROGESTERONE IN SESAME OIL 100MG/ML INJECTABLE 200 ML; PROGESTERONE IN SESAME OIL 150MG/ML INJECTABLE 1000 ML; PROGESTERONE IN SESAME OIL 50MG/ML INJECTABLE 10 MLS 30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1469-2012·2012-08-22

    Franck's Lab Recalls Budesonide Nasal Irrigation Due to Sterility Concerns

    Franck's Lab Inc. is recalling two units of Budesonide nasal irrigation solution because FDA testing found microorganisms in the production clean room.

    Product
    BUDESONIDE (P.F) NASAL IRRIGATION 0.5MG/500ML SOLUTION 1000 ML; BUDESONIDE (P.F) NASAL IRRIGATION 0.6MG/50ML SOLUTION 1500 ML (2 DIFFERENT UNITS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1625-2012·2012-08-22

    Recall of Sterile Thiamine HCL Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile Thiamine HCL injectable products because FDA sampling found microorganisms and fungal growth in the preparation clean room.

    Product
    THIAMINE HCL 100MG/ML INJECTABLE 300 ML 360 ML 450 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1512-2012·2012-08-22

    Franck's Lab Recalls Sterile EDTA Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile EDTA drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 100 ML, 2400 ML, 500 ML; EDTA CALCIUM DISODIUM SOLUTION 2% OPHTHALMIC 5 ML; EDTA DISODIUM (P.F.) 150MG/ML INJECTABLE 1000 ML, 1200 ML, 1500 ML, 400 ML,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1639-2012·2012-08-22

    Franck's Lab Recalls Sterile Vancomycin and Dexamethasone Kits Due to Contamination

    Franck's Lab Inc. is recalling sterile vancomycin and dexamethasone kits because FDA testing found microorganisms and fungal growth in the clean room where the drugs were prepared.

    Product
    VANCOMYCIN/DEXAMETHASONE, LYOPHILIZED 1%/0.1% KIT 2 KIT 20 KIT 24 KIT (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1528-2012·2012-08-22

    Franck's Lab Recalls Sterile Gentamicin Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile gentamicin products distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    GENTAMICIN 40MG/ML (80MG/2ML) INJECTABLE 20 ML, 40 ML, 48 ML, 50 ML; GENTAMICIN / SODIUM BICARBONATE (STERILE) 480MG/LITER SOLUTION 1000 ML; GENTAMICIN /CLINDAMYCIN /POLYMIXIN B/STERILE WATER 0.1%/0.1%/0.05% SOLUTION 250 ML, 500 ML; GENTAMICIN DROPS (FORTIFIED) 14MG/ML (1.4%)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1499-2012·2012-08-22

    Franck's Lab Recalls Dexpantenol Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Dexpantenol 250mg/ml Injectable products because FDA testing found microorganisms in the production clean room.

    Product
    DEXPANTHENOL 250MG/ML INJECTABLE 100 ML, 120 ML, 360 ML, 450 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1576-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs containing methylprednisolone and lidocaine because environmental sampling found microorganisms and fungal growth in the clean room.

    Product
    METHYLPREDNISOLONE ACETATE/LIDOCAINE HCL 40MG/10MG/ML INJECTABLE 100 ML 500 ML; METHYLPREDNISOLONE/LIDOCAINE 80MG/10MG/ML INJECTABLE 24 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1627-2012·2012-08-22

    Franck's Lab Recalls Sterile Tobramycin Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile tobramycin drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    TOBRAMYCIN 1.4% (14MG/ML) OPHTHALMIC 15 ML 3 ML 7 ML; TOBRAMYCIN SOLUTION** 0.3% OPHTHALMIC 30 MLS 5 MLS; TOBRAMYCIN SULFATE** (25X2ML) 80MG/2ML INJECTABLE 100 ML 150 ML 50 MLS; TOBRAMYCIN/AMPHOTERICIN-B/BUDESONIDE, STERILE 125MG/5MG/0.6MG/5ML NASO-NEB 70
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1542-2012·2012-08-22

    Franck's Lab Recalls Sterile Hydromorphone/Clonidine Intrathecal Drugs

    Franck's Lab Inc. is recalling specific sterile hydromorphone/clonidine intrathecal drugs due to microorganisms and fungal growth found in the clean room.

    Product
    HYDROMORPHONE/CLONIDINE P. F. 120MG/1.3MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 120MG/1.8MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 80MG/1.2MCG/ML INTRATHECAL 10 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1595-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    PAPAVERINE/PHENTOLAMINE/ATROPINE NS 3.6MG/0.4MG/0.04MG INJECTABLE 13 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1636-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs, including Ultra-Test, because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    ULTRA-TEST 200 (CYP 80%/PROP 20%) 200MG/ML INJECTABLE 1 ML 10 ML
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1603-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    POTASSIUM CHLORIDE ***(30ML VIAL) 2MEQ/ML INJECTABLE 750 MLS; POTASSIUM CHLORIDE IN NORMAL SALINE 40MEQ/100ML (400MEQ/L) INJECTABLE 1000 ML; POTASSIUM CHLORIDE**(25X20ML) 2MEQ/ML INJECTABLE 500 ML; POTASSIUM PHOSPHATE 4.4MEQ/ML (3MMOL/ML) INJECTABLE 300 ML 750 ML (5 DIF
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1475-2012·2012-08-22

    Franck's Lab Recalls Sterile Intrathecal Bupivacaine and Hydromorphone Mixtures

    Franck's Lab Inc. is recalling six sterile intrathecal drug mixtures due to microbial contamination found in the clean room where they were prepared.

    Product
    BUPIVACAINE/HYDROMORPHONE, P.F. 15MG/40MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 22MG/30MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/20MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/25MG/ML INTRATHECAL 18 ML; BUPIVACAINE/HYDROMORPH
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1503-2012·2012-08-22

    Franck's Lab Recalls Sterile Diphenhydramine Injectable Due to Contamination

    Franck's Lab Inc. is recalling sterile diphenhydramine injectable products because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    DIPHENHYDRAMINE 25MG/ML INJECTABLE 90 ML; DIPHENHYDRAMINE 50MG/ML INJECTABLE 10 ML, 100 ML, 108 ML, 120 MLS, 25 ML, 32 ML, 60 ML, 90 ML, 90 MLS; DIPHENHYDRAMINE, SDV, 25X1ML** 50MG/ML INJECTABLE 25 ML (11 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1551-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs, including Kenalog-40, because FDA testing found microorganisms and fungal growth in the production clean room.

    Product
    KENALOG-40** (MDV 10ML VIAL) 40MG/ML INJECTABLE 50 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1452-2012·2012-08-22

    Franck's Lab Recalls Sterile Alprostadil Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile alprostadil drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML; ALPROSTADIL 15MCG/ML INJECTABLE 5 ML; ALPROSTADIL 20MCG/ML INJECTABLE 10 ML, 10 MLS, 20 ML, 3 ML, 30 ML, 4 ML, 40 ML, 5 ML, 6 ML; ALPROSTADIL 24MCG/ML INJECTABLE 6 ML; ALPROSTADIL 25MCG/ML INJECTABLE 10 M
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1462-2012·2012-08-22

    Franck's Lab Recalls Sterile Intrathecal Baclofen and Morphine Mixtures

    Franck's Lab Inc. is recalling sterile intrathecal Baclofen/Morphine mixtures distributed between November 2011 and May 2012 due to microbial contamination found in the clean room.

    Product
    BACLOFEN/MORPHINE, P.F. 1,000MCG/25MG/ML INTRATHECAL 18 ML; BACLOFEN/MORPHINE, P.F. 1,500MCG/1.5MG/ML INTRATHECAL 40 ML; BACLOFEN/MORPHINE, P.F. 2,000MCG/25MG/ML INTRATHECAL 40 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2016-2012·2012-07-25

    Stryker Recalls T2 Knee Arthrodesis Nails Due to Sterile Barrier Breach Risk

    Stryker is recalling 532 units of T2 Knee Arthrodesis Nails because of a potential breach in the sterile packaging barrier.

    Product
    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1857-2012·2012-07-04

    Hartmann Sterile Gauze Sponges Recalled for Sterile Barrier Defects

    Hartmann USA is recalling specific lots of Econolux sterile gauze sponges because micro holes were detected in the sterile barrier system, potentially compromising sterility.

    Product
    Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing
    Category
    Medical Device
    Distribution
    Distributed nationwide