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.

1651–1675 of 1691

  • SevereFDA (Drugs)·D-1455-2012·2012-08-22

    Franck's Lab Recalls Aminophylline Injectable Due to Sterility Concerns

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

    Product
    AMINOPHYLLINE 20ML, SDV** 500MG (25MG/ML) INJECTABLE 20 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1615-2012·2012-08-22

    Franck's Lab Recalls Sterile Selenium Injectable Due to Contamination

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

    Product
    SELENIUM 200MCG/ML INJECTABLE 150 ML 30 ML 60 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1567-2012·2012-08-22

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

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

    Product
    L-TRYPTOPHAN 15MG/ML INJECTABLE 60 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1461-2012·2012-08-22

    Franck's Lab Recalls Sterile Intrathecal Baclofen and Hydromorphone Mixtures

    Franck's Lab Inc. is recalling sterile intrathecal drug mixtures due to microorganisms and fungal growth found in the clean room.

    Product
    BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/2.9MG/ML INTRATHECAL 20 ML; BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/6MG/ML INTRATHECAL 40 ML; BACLOFEN/HYDROMORPHONE, P.F. 500MCG/50MG/ML INTRATHECAL 40 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1548-2012·2012-08-22

    Franck's Lab Recalls Iohexol Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling 19 units of Iohexol injectable sterile drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    IOHEXOL 200MG IODINE/ML INJECTABLE 120 ML 300 ML 50 ML 600 ML 72 ML; IOHEXOL, 4ML VIAL 240MG IODINE/ML INJECTABLE 200 ML; IOHEXOL, 3ML VIAL 300MG IODINE/ML INJECTABLE 180 ML 600 ML 90 ML 900 ML (10 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1471-2012·2012-08-22

    Franck's Lab Recalls Sterile Intrathecal Drug Mixtures Due to Contamination

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

    Product
    BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 20MG/400MCG/2MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 7.5MG/1.5MCG/50MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 5MG/500MCG/50MG/ML INTRATHECAL (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1619-2012·2012-08-22

    Franck's Lab Recalls Strontium Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Strontium 1 mg/mL Injectable due to microorganisms found in the clean room where sterile products were prepared.

    Product
    STRONTIUM 1 MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1513-2012·2012-08-22

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

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

    Product
    ENGERIX-B, SDV** 20MCG/ML INJECTABLE 1 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1450-2012·2012-08-22

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

    Franck's Lab Inc. is recalling Acyclovir Ophthalmic 3% Ointment and Solution because FDA testing found microorganisms in the production clean room.

    Product
    ACYCLOVIR OPHTHALMIC 3% OINTMENT 5 GM; ACYCLOVIR OPHTHALMIC 3% SOLUTION 5 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1535-2012·2012-08-22

    Franck's Lab Recalls Sterile Hyaluronidase and Lidocaine Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling sterile hyaluronidase and lidocaine injectables because FDA sampling found microorganisms and fungal growth in the clean room where the products were prepared.

    Product
    HYALURONIDASE / LIDOCAINE 7.1U/9.5MG/ML INJECTABLE 105 ML, 210 ML (6 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1581-2012·2012-08-22

    Franck's Lab Recalls Sterile Mitomycin Drugs Due to Contamination

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

    Product
    MITOMYCIN 1MG/ML SOLUTION 160 ML 40 ML 80 ML; MITOMYCIN SOLUTION, STERILE 0.02% (200MCG/ML) OPHTHALMIC 0.5 ML 1 ML 1.5 ML 10 ML 12.5 ML 2 ML
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1496-2012·2012-08-22

    Recall of Depo-Testosterone Injectable Due to Sterility Assurance Concerns

    Franck's Lab Inc. is recalling Depo-Testosterone injectable units because FDA sampling found microorganisms and fungal growth in the clean room where the sterile drugs were prepared.

    Product
    DEPO-TESTOSTERONE, MDV, 10ML** 200MG/ML INJECTABLE 10 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1454-2012·2012-08-22

    Franck's Compounding Lab Recalls Sterile Amikacin Drugs Due to Contamination

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

    Product
    AMIKACIN P. F. 250MG/ML INJECTABLE 2 ML,4 ML; AMIKACIN SULFATE**** 4ML SDV 250MG/ML INJECTABLE 40 ML; AMIKACIN SULFATE, LYOPHILIZED 4MG VIAL INJECTABLE 1 KIT,1 VIAL, 2 KIT, 2 KITS, 2 VIAL, 4 KIT, 4 VIAL; AMIKACIN SULFATE, LYOPHILIZED, OPHTHALMIC KIT 4MG VIAL INJECTABLE 1 KIT, 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1541-2012·2012-08-22

    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 sampling found microorganisms in the production clean room.

    Product
    HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1500MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% SODIUM CHLORIDE) 50MG/500MCG/7.5MG/ML I 18 ML (3 DIFFEENT PROD
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1611-2012·2012-08-22

    Franck's Lab Recalls Ranibizumab Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling 19 units of Ranibizumab injectable because FDA testing found microorganisms in the clean room where the sterile drugs were prepared.

    Product
    RANIBIZUMAB, SDPF - (0.05ML SYRINGE, 31G, 5/16") 10MG/ML INJECTABLE 1 ML 1.25 ML 1.75 ML 2.3 ML 2.35 ML 20 ML 20.15 ML 20.45 ML 20.6 ML 20.9 ML 21.05 ML 21.2 ML 21.25 ML 21.45 ML 21.6 ML 21.7 ML 24.4 ML 28.1 ML (18 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1571-2012·2012-08-22

    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
    METHIONINE / INOSITOL / CHOLINE CHLORIDE 25MG/75MG/75MG/ML INJECTABLE 30 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE 0.8%/1.6%/1.6% INJECTABLE 180 ML 24 ML 240 ML 270 ML 30 ML 90 ML METHIONINE/INOSITOL/CHOLINE CHLORIDE 25MG/50MG/50MG/ML INJECTAB
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1624-2012·2012-08-22

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

    Franck's Lab Inc. is recalling sterile human drugs, including Theracys, because FDA testing found microorganisms and fungal growth in the clean room where the products were prepared.

    Product
    THERACYS, (BCG VACCINE) LIVE W/DILUENT** 81MG INJECTABLE 1 VIAL 1 VIALS 12 VIAL 12 VIALS 2 VIALS 3 VIALS 4 VIAL 4 VIALS 5 VIAL 5 VIALS 6 VIAL 6 VIALS
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1518-2012·2012-08-22

    Fentanyl Injectable Recall Due to Sterility Assurance Failure

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

    Product
    FENTANYL, P.F. 100MCG/ML INJECTABLE 12 ML, 2 ML, 30 ML, 60 ML; FENTANYL, P.F. 50MCG/ML (100MCG/2ML) INJECTABLE 100 ML, 120 ML, 150 ML, 20 ML, 200 ML, 24 ML, 250 ML, 30 ML, 300 ML, 40 ML, 400 ML, 50 ML, 60 ML; FENTANYL, WITH PRESERVATIVES 50MCG/ML INJECTABLE 30 ML (18 DIFFERENT P
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1568-2012·2012-08-22

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

    Franck's Lab Inc. is recalling 32 units of sterile injectable magnesium products distributed between November 2011 and May 2012 because environmental sampling found microorganisms and fungal growth in the clean room.

    Product
    MAGNESIUM CHLORIDE, PRESERVATIVE FREE 20% INJECTABLE 100 ML 1000 ML 500 ML 600 ML 750 ML; MAGNESIUM SULFATE 50% (500MG/ML) INJECTABLE 14 ML 20 ML 4 ML; MAGNESIUM SULFATE IN 5% DEXTROSE 1% (1GM/100ML) INJECTABLE 2400 ML;
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1610-2012·2012-08-22

    Franck's Compounding Lab Recalls Sterile Injectable Drugs Due to Sterility Concerns

    Franck's Compounding Lab is recalling 110 units of QUADMIX injectable drugs because FDA testing found microorganisms and fungal growth in the facility's clean room.

    Product
    QUADMIX 12MG/1MG/10MCG/150MCG/ML INJECTABLE 10 ML; QUADMIX 15MG/0.5MG/5MCG/100MCG/ML INJECTABLE 10 ML; QUADMIX 30MG/0.5MG/5MCG/100MCG/ML INJECTABLE 10 ML; QUADMIX 30MG/1MG/10MCG/100MCG/ML INJECTABLE 1 ML 10 ML
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1520-2012·2012-08-22

    Franck's Lab Recalls Fluorouracil Sterile Ophthalmic and Injectable Solutions

    Franck's Lab Inc. is recalling 14 units of sterile Fluorouracil products due to microbial contamination found in the clean room.

    Product
    FLUOROURACIL (5-FU) SOLUTION 5% OPHTHALMIC 100 ML; FLUOROURACIL (5-FU) SOLUTION IN ARTIFICIAL TEARS 1% OPHTHALMIC 15 ML; FLUOROURACIL (5-FU) SOLUTION, P.F. 0.001% (10MCG/ML) OPHTHALMIC 20 ML, 30 ML; FLUOROURACIL P.F. 5% INJECTABLE 1000 ML,500 ML, 600 ML; FLUOROURACIL SOLUTION
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1532-2012·2012-08-22

    Franck's Lab Recalls Sterile Insulin Due to Microbial Contamination

    Franck's Lab Inc. is recalling Humulin-R Insulin vials distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    HUMULIN-R INSULIN, 10ML VIAL** 100U/ML INJECTABLE 10 MLS (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1559-2012·2012-08-22

    Franck's Lab Recalls Sterile Ophthalmic Drugs Due to Sterility Concerns

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

    Product
    LIDOCAINE HCL/BUPIVACAINE HCL PF 1%/0.375% OPHTHALMIC 30 ML 48 ML 60 ML 90 ML; LIDOCAINE HCL/BUPIVACAINE/HYALURONIDASE PF 0.83%/0.312%/16.67U/ML OPHTHALMIC 30 ML 48 ML 60 ML 90 ML; LIDOCAINE/BUPIVACAINE/HYALURONIDASE PF 1.776%/0.33
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1538-2012·2012-08-22

    Recall of Hydrochloric Acid Injection Due to Sterility Concerns

    Franck's Lab Inc. is recalling Hydrochloric Acid Injection products because FDA testing found microorganisms in the production clean room.

    Product
    HYDROCHLORIC ACID INJECTION 2MG/ML INJECTABLE 400 ML, 60 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide