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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

8501–8525 of 8593

SevereFDA (Drugs)·D-1634-2012·2012-08-22
Franck's Lab Recalls Sterile Ophthalmic Trypan Blue Due to Contamination
Franck's Lab Inc. is recalling sterile ophthalmic trypan blue solutions because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Product
TRYPAN BLUE SOLUTION, P.F. 0.04% OPHTHALMIC 10 ML; TRYPAN BLUE SOLUTION, P.F. 0.05% OPHTHALMIC 0.5 ML 1.5 ML 10 ML 12 ML 2 ML 2.5 ML 3 ML 4 ML 4.5 ML 5 ML
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-1478-2012·2012-08-22
Franck's Lab Recalls Sterile Intrathecal Bupivacaine and Morphine Sulfate Mixtures
Franck's Lab Inc. is recalling four sterile intrathecal drug mixtures because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Product
BUPIVACAINE/MORPHINE SULFATE, P.F. 2.5MG/10MG/ML INTRATHECAL 40 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/25MG/ML INTRATHECAL 20 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/50MG/ML INTRATHECAL 18 ML, 35 ML (4 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-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-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-1477-2012·2012-08-22
Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile injectable drugs containing bupivacaine, lidocaine, and methylprednisolone because FDA sampling found microorganisms and fungal growth in the clean room.
Product
BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.17% / 0.67% / 2.7% INJECTABLE 15 ML, 18.75 ML, 26.25 ML, 37.5 ML, 45 ML; BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.22% / 0.88% / 0.88% INJECTABLE 450 ML, 900 ML (7 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1629-2012·2012-08-22
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
TRIMIX 9MG / 0.3MG /3.3MCG INJECTABLE 6 ML; TRIMIX 9MG / 0.3MG /6.6MCG INJECTABLE 6 ML; TRIMIX 9MG / 1MG / 10MCG INJECTABLE 10 ML; TRIMIX ((LYOPHILIZED)) - 2ML VIAL 30MG / 1MG / 10MCG INJECTABLE 10 ML 10 VIALS 2 ML 4 ML 50 ML; TRIMIX ((LYOPHILIZ
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1547-2012·2012-08-22
Franck's Lab Recalls Sterile Insulin Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile insulin products distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
INSULIN, LO-DOSE (FROM HUMALOG) 10 UNITS/ML INJECTABLE 10 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-1506-2012·2012-08-22
Franck's Lab Recalls Sterile DMSO and Heparin Solutions Due to Contamination
Franck's Lab Inc. is recalling specific sterile DMSO and Heparin solutions because FDA testing found microorganisms and fungal growth in the production clean room.
Product
DMSO/HEPARIN 50%/20,000U/25ML SOLUTION 100 ML, 25 ML; DMSO/HEPARIN 50%/5000U/50ML SOLUTION 300 ML, 400 ML (4 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1465-2012·2012-08-22
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
BIEST(80/20) 6.25MG/GM (1.25MG/0.2ML) I-CREAM 6 ML (5 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-1530-2012·2012-08-22
Franck's Lab Recalls Glycerin Ophthalmic Products Due to Sterility Concerns
Franck's Lab Inc. is recalling four glycerin ophthalmic products because FDA testing found microorganisms and fungal growth in the facility's clean room.
Product
GLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15 ML (4 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1583-2012·2012-08-22
Franck's Lab Recalls Sterile Mitomycin Injectable Drugs Due to Contamination
Franck's Lab Inc. is recalling sterile Mitomycin/Lidocaine/Epinephrine injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room.
Product
MITOMYCIN/LIDOCAINE/EPINEPHRINE 0.04%/0.02%/0.1% INJECTABLE 5 ML; MITOMYCIN/LIDOCAINE/EPINEPHRINE 0.08MG/13.3MG/6.7MCG/ML INJECTABLE 0.2 ML (2 DIFFERENT PRODUCTS)
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-1451-2012·2012-08-22
Franck's Lab Recalls Sterile Aflibercept Syringes Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile Aflibercept syringes distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
AFLIBERCEPT, SDPF - (0.05ML SYRINGE, 31G, 5/16") 40MG/ML INJECTABLE 0.35 ML, 0.95 ML, 1.25 ML (3 DIFFERENT PRODUCTS)
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-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-1574-2012·2012-08-22
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 testing found microorganisms in the production clean room.
Product
METHYLCOBALAMIN/FOLIC ACID - KIT 10MG/0.4MG/ML INJECTABLE 1 KIT METHYLCOBALAMIN/FOLIC ACID 1000MCG/0.4MG/ML INJECTABLE 10 ML METHYLCOBALAMIN/FOLIC ACID 10MG/0.4MG/ML INJECTABLE 10 ML 8 ML 8 MLS
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1474-2012·2012-08-22
Franck's Lab Recalls Sterile Bupivacaine and Fentanyl Intrathecal Solutions
Franck's Lab Inc. is recalling sterile bupivacaine and fentanyl intrathecal solutions due to microbial contamination found in the clean room.
Product
BUPIVACAINE/FENTANYL IN SODIUM CHLORIDE 0.9% P. F. 30 MG/200 MCG/ML INTRATHECAL 40 ML (1 PRODUCT)
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-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-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-1480-2012·2012-08-22
Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile injectable drugs and ophthalmic products distributed between November 2011 and May 2012 because FDA testing found microorganisms in the production clean room.
Product
CALCIUM CHLORIDE DIHYDRATE, P.F. 100MG/ML (10%) INJECTABLE 200 ML, 240 ML, 500 ML; CALCIUM EDTA 150MG/ML INJECTABLE 1000 ML, 800 ML, 900 ML; CALCIUM EDTA 300MG/ML INJECTABLE 400 ML, 500 ML; CALCIUM GLUCONATE OPHTHALMIC IN ARTIFICIAL TEARS 1% OPHTHALMIC 500 ML (9 DIFFERENT PRODUC
Category
Drug
Distribution
Distributed nationwide

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8501–8525 of 8593