The Recall Desk

Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,691
Critical
12
Severe
931
Most recent
2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) 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 failure 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.

1676–1691 of 1691

  • SevereFDA (Drugs)·D-1539-2012·2012-08-22

    Franck's Lab Recalls Sterile Hydrogen Peroxide Injectable Due to Contamination

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

    Product
    HYDROGEN PEROXIDE PF 3% INJECTABLE 150 ML, 200 ML, 50 ML, 60 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1554-2012·2012-08-22

    Franck's Lab Recalls Sterile L-Arginine Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile L-Arginine 500mg/mL injectable products distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the clean room.

    Product
    L-ARGININE 500MG/ML INJECTABLE 2500 ML 500 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1467-2012·2012-08-22

    Recall of Boron Injectable Due to Sterility Assurance Failure

    Franck's Lab is recalling Boron 2mg/mL Injectable because FDA sampling found microorganisms in the clean room where sterile products were prepared.

    Product
    BORON 2MG/ML INJECTABLE 40 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1460-2012·2012-08-22

    Franck's Lab Recalls Sterile Intrathecal Drug Mixtures Due to Sterility Concerns

    Franck's Lab Inc. is recalling specific sterile intrathecal drug mixtures because FDA testing found microorganisms in the production clean room.

    Product
    BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 1000MCG/7.5MG/1000MCG/50MG/ML INTR 40 ML; BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 50MCG/2MG/200MCG/50MG/ML INTRATHEC 18 ML; BACLOFEN/CLONIDINE/BUPIVACAINE/MORPHINE, P.F. 500MCG/1/7.5/50MG/ML INTRATHECAL 40 ML (3 DIFFERENT PRODUC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1459-2012·2012-08-22

    Franck's Lab Recalls Baclofen Due to Sterility Concerns

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

    Product
    BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 2,000MCG/ML (2MG/ML) INTRATHECAL 40 ML; BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 600MCG/ML INTRATHECAL 40 ML; BACLOFEN, P.F. 1,000MCG/ML (1MG/ML) INTRATHECAL 20 ML, 40 ML; BACLOFEN, P.F. 500MCG/ML (0.5MG/ML) INTRATHECAL 40 ML; B
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1556-2012·2012-08-22

    Franck's Lab Recalls Sterile Levofloxacin Injectable Due to Sterility Concerns

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

    Product
    LEVOFLOXACIN, P.F. (PREMIXED SOLUTION) 5MG/ML INJECTABLE 1200 ML 500 ML 700 ML 800 ML LEVOFLOXACIN, P.F. 25MG/ML(500MG/20ML) INJECTABLE 300 ML 500 ML (6 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1495-2012·2012-08-22

    Franck's Lab Recalls Dapiprazole Ophthalmic Products Due to Sterility Concerns

    Franck's Lab Inc. is recalling Dapiprazole ophthalmic products because FDA sampling found microorganisms in the clean room where they were prepared.

    Product
    DAPIPRAZOLE OPHTHALMIC 0.5% SOLUTION 10 ML; DAPIPRAZOLE, LYOPHILIZED, OPHTHALMIC KIT 0.5% POWDER 1 KIT, 10 KIT, 2 KIT, 3 KIT, 4 KIT, 6 KIT (7 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1616-2012·2012-08-22

    Franck's Lab Recalls Sermorelin Acetate Due to Sterility Concerns

    Franck's Lab Inc. is recalling Sermorelin Acetate products because FDA sampling found microorganisms in the clean room where they were prepared.

    Product
    SERMORELIN ACETATE, LYOPHILIZED 6MG KIT 1 KIT 2 KIT; SERMORELIN ACETATE, LYOPHILIZED 6MG VIAL 2 VIAL; SERMORELIN ACETATE, LYOPHILIZED 9MG KIT 1 KIT 3 KIT 6 KIT; SERMORELIN ACETATE, LYOPHILIZED
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1565-2012·2012-08-22

    Franck's Lab Recalls Sterile Lithium Chloride Injectable Due to Contamination

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

    Product
    LITHIUM CHLORIDE 5MG/ML INJECTABLE 30 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1586-2012·2012-08-22

    Franck's Lab Recalls Moxifloxacin Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Moxifloxacin injectable products because FDA sampling found microorganisms in the clean room where they were prepared.

    Product
    MOXIFLOXACIN 150MCG/0.1ML (1.5MG/ML) INJECTABLE 10 ML 20 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1637-2012·2012-08-22

    Franck's Lab Recalls Sterile Vanadyl Sulfate Injectable Due to Contamination

    Franck's Lab Inc. is recalling sterile Vanadyl Sulfate Solution injectable because FDA sampling found microorganisms and fungal growth in the preparation clean room.

    Product
    VANADYL SULFATE SOLUTION 200MCG/ML INJECTABLE 60 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1523-2012·2012-08-22

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

    Franck's Lab Inc. is recalling specific sterile injectable drugs because FDA testing found microorganisms and fungal growth in the facility's clean room.

    Product
    FORSKOLIN/PAPAVARINE/PHENTOLAMINE 200MCG/40MG/3MG/ML INJECTABLE 5 ML; FORSKOLIN/PAPAVARINE/PHENTOLAMINE/ALPROSTADIL 100MCG/30MG/1MG/30MCG/ML INJECTABL 10 ML; (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1487-2012·2012-08-22

    Franck's Lab Recalls Copper Gluconate Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Copper Gluconate 2mg/mL Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.

    Product
    COPPER GLUCONATE 2MG/ML INJECTABLE 30 ML, 60 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1635-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Contamination

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

    Product
    TWINJECT*** 0.3 MG INJECTABLE 1 PK (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1589-2012·2012-08-22

    Franck's Lab Recalls Ondansetron Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling 16 units of Ondansetron HCL injectable products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    ONDANSETRON HCL, MDV 2MG/ML (40MG/20ML) INJECTABLE 200 ML 40 ML 400 ML 48 ML 600 ML 800 ML; ONDANSETRON HCL, P.F. 2MG/ML (4MG/2ML) INJECTABLE 20 ML 200 ML 24 ML 40 ML 48 ML (11 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1370-2012·2012-06-20

    Bausch & Lomb Recalls Murocel Lubricant Ophthalmic Solution Due to Sterility Concerns

    Bausch & Lomb is recalling 59,777 bottles of Murocel Lubricant Ophthalmic Solution because the product failed antimicrobial effectiveness testing.

    Product
    Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incorporated, Tampa, FL 33637, NDC 24208-280-15
    Category
    Drug
    Distribution
    Distributed nationwide