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 the agency’s own highest classification or reported deaths or serious injuries, 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

36776–36800 of 39777

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…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1546-2012·2012-08-22
Franck's Compounding Lab Recalls Indocyanine Green Injectable Kits Due to Sterility Concerns
Franck's Compounding Lab is recalling Indocyanine Green injectable kits because FDA sampling found microorganisms and fungal growth in the clean room where sterile products were prepared.
Product
INDOCYANINE GREEN - KIT 15MG INJECTABLE 1 KIT, 100 KIT, 12 KIT, 20 KIT, 50 KIT, 6 KIT, 75 KIT, 8 KIT; INDOCYANINE GREEN - KIT 1MG INJECTABLE 1 KIT, 10 `KIT, 10 KIT, 100 KIT, 18 VIAL, 2 KIT (51 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-1449-2012·2012-08-22
Franck's Lab Recalls Acetylcysteine Ophthalmic Solutions Due to Sterility Concerns
Franck's Lab Inc. is recalling specific acetylcysteine ophthalmic solutions because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Product
ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 10% SOLUTION 10 ML, 2 ML, 5 ML, 6 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 2.5% SOLUTION 20 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 5% SOLUTION 3 ML (6 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1542-2012·2012-08-22
Franck's Lab Recalls Sterile Hydromorphone/Clonidine Intrathecal Drugs
Franck's Lab Inc. is recalling specific sterile hydromorphone/clonidine intrathecal drugs due to microorganisms and fungal growth found in the clean room.
Product
HYDROMORPHONE/CLONIDINE P. F. 120MG/1.3MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 120MG/1.8MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 80MG/1.2MCG/ML INTRATHECAL 10 ML (3 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1591-2012·2012-08-22
Franck's Lab Recalls Sterile Paclitaxel Injectable Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile Paclitaxel injectable products distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
PACLITAXEL 6MG/ML INJECTABLE 500 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-1564-2012·2012-08-22
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 FDA sampling found microorganisms in the clean room.
Product
LISSAMINE GREEN SOLUTION 1% OPHTHALMIC 10 ML (1 PRODUCT)
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-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 (Food)·F-1942-2012·2012-08-22
St Clair Foods Recalls Diced Yellow Onions for Listeria Risk
St Clair Foods is recalling diced yellow onions distributed by Sysco in Tennessee due to potential Listeria monocytogenes contamination.
Product
4/5 SYS DICED YELLOW ONIONS, 720611 SUPC 7750243, Distributed by: SYSCO
Category
Food
Distribution
1 state
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-1458-2012·2012-08-22
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 because FDA sampling found microorganisms in the clean room.
Product
ATROPINE SULFATE 0.4MG/ML INJECTABLE 12 ML, 2 ML, 20 ML, 24 ML, 25 ML, 3 ML; ATROPINE/EPINEPHRINE/ BSS 0.02MG/0.1MG/ML INJECTABLE 10 ML, 5 ML (8 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1456-2012·2012-08-22
Franck's Compounding Lab Recalls Sterile Amphotericin B Drugs Due to Contamination
Franck's Compounding Lab is recalling sterile Amphotericin B drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.
Product
AMPHOTERICIN B OPHTHALMIC (0.5ML, LL SYRINGE) P.F. 10MCG/0.1ML INJECTABLE 1 ML, 1.5 ML, 2 ML, 2.5 ML, 5 ML; AMPHOTERICIN B OPHTHALMIC 5MCG/0.1ML INJECTABLE, 0.2 ML, 0.4 ML, 3 ML; AMPHOTERICIN B, LYOPHILIZED 150MCG INJECTABLE 2 VIAL; AMPHOTERICIN-B, NEBULIZATION, STERILE 5MG/2ML…
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-1509-2012·2012-08-22
Franck's Lab Recalls Sterile Doxorubicin HCL Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile Doxorubicin HCL vials because FDA sampling found microorganisms and fungal growth in the clean room where the drugs were prepared.
Product
DOXORUBICIN HCL, LYOPHILIZED 10MG VIAL 2 VIAL; DOXORUBICIN HCL, LYOPHILIZED 50MG VIAL 1 VIAL, 10 VIAL, 5 VIAL (4 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2207-2012·2012-08-22
Philips Essenta DR X-Ray System Recalled Due to Potential C-Arm Fall
Philips Healthcare Inc. is recalling seven Essenta DR X-ray systems because the C-arm may fall. The recall covers units distributed in the US and several international countries.
Product
Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are…
Category
Medical Device
Distribution
3 states
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-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-1491-2012·2012-08-22
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
CYCLOPENT/LIDOCAINE/PHENYLEPHRINE/TROPICAMIDE 0.5%/0.5%/0.625%/0.25% OPHTHALMIC 20 ML (1 PRODUCT)
Category
Drug
Distribution
Distributed nationwide
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-1628-2012·2012-08-22
Franck's Compounding Lab Recalls Sterile Triamcinolone Acetonide Drugs
Franck's Compounding Lab is recalling sterile triamcinolone acetonide drugs distributed between November 2011 and May 2012 due to the presence of microorganisms and fungal growth in the clean room.
Product
TRIAMCINOLONE ACETONIDE 4MG/ML (0.4MG/0.1ML) INJECTABLE 10 ML 5 ML TRIAMCINOLONE ACETONIDE (T), STSL (0.025ML SYRINGE, 30G, 1/2") 40MG/ML (4MG/0.1M 0.075 SYR 0.1 SYR TRIAMCINOLONE ACETONIDE 0.25ML SYRINGE (T) 40MG/ML (4MG/0.1ML) OPHTHALMIC 0.25 ML 0.5 ML…
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-1483-2012·2012-08-22
Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile human drugs, including Chorionic Gonadotropin, because FDA sampling found microorganisms in the clean room.
Product
CHORIONIC GONADOTROPIN (STANDARD) - 21 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD) - 45 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD)-21 DAY 125 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD)-45 DAY 125 UNIT VIALS KIT 1 KIT…
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

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36776–36800 of 39777