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.

1626–1650 of 1691

  • SevereFDA (Drugs)·D-1521-2012·2012-08-22

    Franck's Lab Recalls Folic Acid Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Folic Acid 10mg/mL Injectable because FDA sampling found microorganisms and fungal growth in the clean room where sterile products were prepared.

    Product
    FOLIC ACID 10MG/ML INJECTABLE 60 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1507-2012·2012-08-22

    Franck's Lab Recalls Sterile DMSO Heparin Methyldnisolone Solution Due to Sterility Concerns

    Franck's Lab Inc. is recalling sterile DMSO/Heparin/Methylprednisolone solution because FDA sampling found microorganisms and fungal growth in the clean room where the products were prepared.

    Product
    DMSO/HEPARIN/METHYLPREDNISOLONE 50%/5000U/40MG/50ML SOLUTION 300 MLS (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1516-2012·2012-08-22

    Franck's Lab Recalls Sterile Ethyl Alcohol Injections Due to Contamination

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

    Product
    ETHYL ALCOHOL 10% INJECTABLE 30 ML; ETHYL ALCOHOL 100%INJECTABLE 10 ML, 100 ML, 20 ML, 40 ML, 5 ML, 60 ML; ETHYL ALCOHOL 20% INJECTABLE 5 ML; ETHYL ALCOHOL 5% INJECTABLE 180 ML, 30 ML; ETHYL ALCOHOL 95% INJECTABLE 10 ML, 8 ML; ETHYL ALCOHOL OPHTHALMIC 40% INJECTABLE 50 ML (13 DI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1597-2012·2012-08-22

    Phentolamine Injectable Recall Due to Sterility Assurance Failure

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

    Product
    PHENTOLAMINE 10MG/ML INJECTABLE 6 ML; PHENTOLAMINE 1MG/ML INJECTABLE 2 ML 5 ML; PHENTOLAMINE 5MG/ML INJECTABLE 20 ML 50 ML (5 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1570-2012·2012-08-22

    Recall of Mepivacaine Injectable Due to Sterility Assurance Failure

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

    Product
    MEPIVACAINE HCL/EPINEPHRINE. 2%/1:100,000 (0.001%) INJECTABLE 30 ML 60 ML; MEPIVICAINE HCL 3% (30MG/ML) INJECTABLE 6 MLS (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1592-2012·2012-08-22

    Franck's Lab Recalls Sterile Pantothenic Acid Injectable Due to Microbial Contamination

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

    Product
    PANTOTHENIC ACID 1MG/ML INJECTABLE 30 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1550-2012·2012-08-22

    Franck's Lab Recalls Isosulfan Blue Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Isosulfan Blue 1% Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.

    Product
    ISOSULFAN BLUE 1% INJECTABLE 10 ML 15 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1641-2012·2012-08-22

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

    Franck's Lab Inc. is recalling 23 sterile injectable vitamin products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    VITAMIN K (PHYTONADIONE) 10MG/ML INJECTABLE 1 ML 2 ML 4 ML; VITAMIN K (PHYTONADIONE) 5MG/ML INJECTABLE 2 ML; VITAMIN A AQUEOUS EMULSION 50,000 U/ML INJECTABLE 20 ML 40 ML; VITAMIN B COMPLEX (B1,B2,B3,B5,B6) 100/5/100/100/100MG/ML INJECTABLE 120 ML 150 ML
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1642-2012·2012-08-22

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

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

    Product
    VORICONAZOLE OPHTHALMIC 1% (10MG/ML) SOLUTION 15 ML; VORICONAZOLE OPHTHALMIC, (0.5ML, LL SYRINGE), P.F. 0.1% (100MCG/0.1ML) INJECTABL 0.5 ML 1 ML 1.5 ML 2 ML 2.5 ML 5 ML; VORICONAZOLE OPHTHALMIC, P.F. (SINGLE DOSE ONLY) 0.1% (100MCG/0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1613-2012·2012-08-22

    Franck's Lab Recalls Riboflavin Ophthalmic Solutions Due to Sterility Concerns

    Franck's Lab Inc. is recalling specific riboflavin ophthalmic solutions because FDA testing found microorganisms in the production clean room.

    Product
    RIBOFLAVIN SOLUTION 0.1% OPHTHALMIC 10 ML 5 ML; RIBOFLAVIN SOLUTION, P.F. 0.1% OPHTHALMIC 90 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1484-2012·2012-08-22

    Franck's Lab Recalls Sterile Chromium Picolinate Injectable Due to Contamination

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

    Product
    CHROMIUM PICOLINATE 200MCG/ML INJECTABLE 60 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1614-2012·2012-08-22

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

    Franck's Lab Inc. is recalling sterile Rubidium 200mcg/mL injectable products distributed between November 2011 and May 2012. The recall was initiated after FDA sampling found microorganisms and fungal growth in the clean room used for preparation.

    Product
    RUBIDIUM 200MCG/ML INJECTABLE 30 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1607-2012·2012-08-22

    Recall of Procaine HCL Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Procaine HCL injectable products because FDA testing found microorganisms in the production clean room.

    Product
    PROCAINE HCL, P.F. 1% INJECTABLE 1000 ML 180 ML; PROCAINE HCL, P.F. 2% INJECTABLE 300 ML 360 ML 450 ML; PROCAINE HCL, P.F. 8% INJECTABLE 20 ML 60 ML (7 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1494-2012·2012-08-22

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

    Franck's Lab Inc. is recalling 40 units of cyclosporine ophthalmic drugs because FDA sampling found microorganisms in the clean room where they were prepared.

    Product
    CYCLOSPORINE (A) AQUEOUS (HUMAN) 0.5% OPHTHALMIC 10 ML, 5 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 0.2% OPHTHALMIC 10 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 1% OPHTHALMIC 10 ML; CYCLOSPORINE (A) CORN OIL SOLUTION 2% OPHTHALMIC 15 ML; CYCLOSPORINE (A) OIL SOLUTION 1% OPHTH
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1584-2012·2012-08-22

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

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

    Product
    MOLYBDENUM 250MCG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1544-2012·2012-08-22

    Franck's Lab Recalls Hydroxyprogesterone Caproate Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling 48 units of Hydroxyprogesterone Caproate Injectable because FDA sampling found microorganisms and fungal growth in the clean room where the sterile drugs were prepared.

    Product
    HYDROXYPROGESTERONE CAPROATE 250MG/ML INJECTABLE 10 ML, 12 ML, 13 ML, 15 ML, 3 ML, 30 ML, 4 ML, 5 ML, 6 ML, 7 ML, 9 ML (11 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1563-2012·2012-08-22

    Franck's Lab Recalls Lidocaine/Tetracaine Ophthalmic Solution Due to Sterility Concerns

    Franck's Lab Inc. is recalling Lidocaine/Tetracaine Ophthalmic Solution because FDA testing found microorganisms and fungal growth in the clean room where the sterile drugs were prepared.

    Product
    LIDOCAINE/TETRACAINE OPHTHALMIC 4%/0.5% SOLUTION 10 ML 15 ML 20 ML 200 ML 240 ML 300 ML 400 ML (7 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1596-2012·2012-08-22

    Recall of Penicillin G Potassium Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Penicillin G Potassium Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.

    Product
    PENICILLIN G POTASSIUM 10,000U/ML INJECTABLE 1 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1566-2012·2012-08-22

    Franck's Lab Recalls Lorazepam Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Lorazepam 2mg/mL injectable products because FDA testing found microorganisms and fungal growth in the facility's clean room.

    Product
    LORAZEPAM 2MG/ML INJECTABLE 10 ML 20 ML 200 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1531-2012·2012-08-22

    Heparin Sodium Injectable Recall Due to Sterility Assurance Failure

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

    Product
    HEPARIN LOCK SODIUM*** (25X1ML) 100U/ML INJECTABLE 50 ML; HEPARIN LOCK SODIUM*** (25X5ML) 100U/ML INJECTABLE 125 MLS; HEPARIN SODIUM (25X30ML)** 1000U/ML(1MU/ML) INJECTABLE 120 ML, 60 ML, 90 ML; HEPARIN SODIUM **25X1ML 1000U/ML(1MU/ML INJECTABLE 25 ML, 50 ML (7 DIFFERENT PRODUCT
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1640-2012·2012-08-22

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

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

    Product
    VERAPAMIL HCL 10MG/ML INJECTABLE 80 ML; VERAPAMIL HCL 20MG/ML INJECTABLE 50 ML; VERAPAMIL HCL, SDV*** (5X2ML VIAL) 2.5MG/ML INJECTABLE 20 MLS 40 ML 50 ML 50 MLS (6 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1644-2012·2012-08-22

    Franck's Lab Recalls Zinc Chloride Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling Zinc Chloride 10mg/ml Injectable because FDA sampling found microorganisms and fungal growth in the clean room where sterile products were prepared.

    Product
    ZINC CHLORIDE 10MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1573-2012·2012-08-22

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

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

    Product
    METHYLCOBALAMIN 1,000MCG/ML INJECTABLE 10 ML 12 ML 15 ML 150 ML 2 ML 26 MLS 3 ML 30 ML 30 MLS
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1481-2012·2012-08-22

    Franck's Lab Recalls Cefazolin Sterile Drugs Due to Contamination

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

    Product
    CEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML; CEFAZOLIN VIAL*(25X1GM) 1GM INJECTABLE 10 VIAL (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide