The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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8451–8475 of 8593

  • SevereFDA (Drugs)·D-1490-2012·2012-08-22

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

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

    Product
    CYCLOPENT/KETOROLAC/PHENYLEPH/TROPICAMIDE 1%/0.5%/2.5%/1% OPHTHALMIC 70 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1473-2012·2012-08-22

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

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

    Product
    BUPIVACAINE/CLONIDINE/MORPHINE/ZICONOTIDE, P.F. 20MG/400MCG/20MG/1.5MCG/ML INTRA 20 ML (1 PRODUCT)
    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-1604-2012·2012-08-22

    Franck's Lab Recalls Povidone-Iodine Ophthalmic Solutions Due to Sterility Concerns

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

    Product
    POVIDONE-IODINE OPHTHALMIC 5% SOLUTION 10 ML 125 ML 15 ML 40 ML 50 ML; POVIDONE-IODINE, BUFFERED IN BSS 4.6% OPHTHALMIC 100 ML 120 ML 200 ML (8 DIFFERENT PRODUCTS)
    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-1561-2012·2012-08-22

    Franck's Compounding Lab Recalls Sterile Ophthalmic Drug Mixtures

    Franck's Compounding Lab is recalling sterile ophthalmic drug mixtures due to the presence of microorganisms and fungal growth in the clean room where they were prepared.

    Product
    LIDOCAINE/EPINEPHRINE/BUPIVACAINE, PF 1%/0.00025%/0.375% OPHTHALMIC 30 ML 48 ML 60 ML 90 ML; LIDOCAINE/EPINEPHRINE/BUPIVACAINE, PF 1%/0.0005%/0.25% OPHTHALMIC 30 ML 48 ML 60 ML 90 ML (8 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1508-2012·2012-08-22

    Franck's Lab Recalls Sterile Ophthalmic Solutions Due to Microbial Contamination

    Franck's Lab is recalling specific sterile eye drops because FDA testing found microorganisms and fungal growth in the production clean room.

    Product
    DMSO/VITAMIN C/GLUTATHIONE SOLUTION 6.25%/1.25%/1.25% OPHTHALMIC 10 ML, 15 ML, 5 ML (3 DIFFERENT PRODUCTS)
    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-1580-2012·2012-08-22

    Franck's Lab Recalls Sterile Midazolam Due to Microbial Contamination

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

    Product
    MIDAZOLAM 1MG/ML (5ML VIAL) INJECTABLE 100 ML; MIDAZOLAM 1MG/ML INJECTABLE 100 ML 108 ML 1250 ML 20 ML 292 ML 300 ML 40 ML 500 ML 90 ML; MIDAZOLAM 5MG/ML INJECTABLE 140 ML 150 ML 200 ML; MIDAZOLAM HCL ***(10X10ML) 5MG/ML INJECTABLE 100 MLS (13 DIFFER
    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-1468-2012·2012-08-22

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

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

    Product
    BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.25MG/ML OPHTHALMIC 2 ML, 2.5 ML, 5 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.5MG/ML OPHTHALMIC 1.5 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 1% OPHTHALMIC 0.5 ML,1 M
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1593-2012·2012-08-22

    Franck's Lab Recalls Sterile Papaverine HCL Injectable Due to Sterility Concerns

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

    Product
    PAPAVERINE HCL **(10ML VIAL) 30MG/ML INJECTABLE 10 ML 100 ML (2 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-1626-2012·2012-08-22

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

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

    Product
    THIOTEPA, LYOPHILIZED 15MG INJECTABLE 8 VIAL; THIOTEPA, LYOPHILIZED 30MG INJECTABLE 4 VIAL 8 VIAL; THIOTEPA, LYOPHILIZED 60MG INJECTABLE 2 VIAL (4 DIFFERENT PRODUCTS)
    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-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-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-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-1514-2012·2012-08-22

    Franck's Lab Recalls Sterile Epinephrine Products Due to Microbial Contamination

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

    Product
    EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJECTABLE 25 ML; EPINEPHRINE HCL SOLUTION 1% OPHTHALMIC 10 ML, 20 ML; EPIINEPHRINE P.F. (SULFITE-FREE) 1:1,000 (1MG/ML) INJECTABLE 1 ML, 2 ML, 20 ML, 25 ML, 3 ML, 30 ML, 4 ML, 5 ML, 50 ML; EPINEPHRINE PF IN BSS, OPHTHALMIC (CONTAINS S
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1510-2012·2012-08-22

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

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

    Product
    DROPTAINER STERILE PLASTIC (2 X 7ML) 10 BOTTLE 4 PK (2 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-1572-2012·2012-08-22

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

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

    Product
    METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/B12 (C) 0.8/1.6/1.6/0.0001/0.03% INJE 10 ML 200 ML 30 ML 50 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE/CHROM/B12 (M) 0.8/1.6/1.6/0.0001/0.03% INJE 10 ML 150 ML 180 ML
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1500-2012·2012-08-22

    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 in the clean room.

    Product
    DEXTROSE/PROCAINE HCL P.F. 12%/1% INJECTABLE 400 ML ( 1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1498-2012·2012-08-22

    Franck's Lab Recalls Sterile Dexamethasone Drugs Due to Contamination

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

    Product
    DEXAMETHASONE/BACTERIOSTATIC WATER IONTOPHORESIS 0.5MG/5ML(0.1MG/ML) INJECTABL 30 ML (1 PRODUCT) 40 ML DEXAMETHASONE SDPF (0.1ML SYRINGE, 31G, 5/16" ) 0.4MG/ML INJECTABLE 0.3 ML 0.5 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 10MG/ML
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1482-2012·2012-08-22

    Franck's Lab Recalls Sterile Ceftazidime Ophthalmic Products Due to Sterility Concerns

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

    Product
    CEFTAZIDIME OPHTHALMIC, P.F. 22.5MG/ML (2.25%) OPHTHALMIC 1 ML, 2ML, 2 MLS, 6 ML CEFTAZIDIME, LYOPHILIZED, OPHTHALMIC KIT 2.25% KIT 1 KIT
    Category
    Drug
    Distribution
    Distributed nationwide