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

11651–11675 of 11827

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
SevereFDA (Drugs)·D-1534-2012·2012-08-22
Franck's Lab Recalls Sterile Hyaluronidase Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile hyaluronidase injectables distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
HYALURONIDASE - PRESERVATIVE FREE 150 U/ML INJECTABLE 1 MLS, 10 MLS, 100 MLS, 12 MLS, 12.5 ML, 120 MLS, 15 MLS, 16 ML, 16 MLS, 2 MLS, 20 ML, 20 MLS, 24 MLS, 25 ML, 30 ML, 30 MLS, 36 MLS, 4 MLS, 40 MLS, 44 ML, 5 MLS, 50 ML, 50 MLS, 6 ML, 6 MLS, 60 MLS, 8 MLS, 80 MLS, 9 ML…
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-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…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1560-2012·2012-08-22
Franck's Lab Recalls Sterile Lidocaine and Epinephrine Injectable Drugs
Franck's Lab Inc. is recalling sterile lidocaine and epinephrine injectable drugs due to the presence of microorganisms and fungal growth in the clean room where they were prepared.
Product
LIDOCAINE HCL/EPINEPHRINE IN BSS - P.F., SULFITE-FREE 0.75%/0.025% INJECTABLE 24 ML 6 ML; LIDOCAINE HCL/EPINEPHRINE, P.F., SULFITE-FREE 2%/1:100,000 (0.001%) INJECTABLE 10 ML 40 ML; LIDOCAINE HCL/EPINEPHRINE. 2%/1:100,000 (0.001%) INJECTABLE 100 ML…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1617-2012·2012-08-22
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
SESAME OPHTHALMIC OIL 60 ML (1 PRODUCT)
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-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-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-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…
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-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-1540-2012·2012-08-22
Franck's Lab Recalls Sterile Hydromorphone Products Due to Microbial Contamination
Franck's Lab Inc. is recalling four sterile hydromorphone products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Product
HYDROMORPHONE P.F. 20MG/ML INTRATHECAL 40 ML; HYDROMORPHONE P.F. 25MG/ML INTRATHECAL 18 ML; HYDROMORPHONE P.F. 30MG/ML INTRATHECAL 18 ML; HYDROMORPHONE P.F. 50MG/ML INTRATHECAL 40 ML (4 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1589-2012·2012-08-22
Franck's Lab Recalls Ondansetron Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling 16 units of Ondansetron HCL injectable products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Product
ONDANSETRON HCL, MDV 2MG/ML (40MG/20ML) INJECTABLE 200 ML 40 ML 400 ML 48 ML 600 ML 800 ML; ONDANSETRON HCL, P.F. 2MG/ML (4MG/2ML) INJECTABLE 20 ML 200 ML 24 ML 40 ML 48 ML (11 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1633-2012·2012-08-22
Franck's Lab Recalls Sterile Ophthalmic Solutions Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile ophthalmic solutions distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
TROPICAMIDE/PHENYLEPHRINE OPHTHALMIC 15:1 SOLUTION 128 ML 480 ML 496 ML 576 ML 90 ML (5 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1539-2012·2012-08-22
Franck's Lab Recalls Sterile Hydrogen Peroxide Injectable Due to Contamination
Franck's Lab Inc. is recalling sterile hydrogen peroxide injectable products because FDA sampling found microorganisms and fungal growth in the clean room.
Product
HYDROGEN PEROXIDE PF 3% INJECTABLE 150 ML, 200 ML, 50 ML, 60 ML (4 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1582-2012·2012-08-22
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 and fungal growth in the clean room.
Product
MITOMYCIN/BUPIVACAINE WITH EPI 1:200,000 0. 04MG/0.5% PER 0.3ML SYR INJECTABLE 3 ML (1 PRODUCT)
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-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-1493-2012·2012-08-22
Franck's Lab Recalls Sterile Ophthalmic Drugs Due to Contamination
Franck's Lab Inc. is recalling sterile ophthalmic drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the production clean room.
Product
CYCLOPENTALATE/PHENYLEPHRINE 1%/2.5% OPHTHALMIC 5 ML (1 PRODUCT)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1551-2012·2012-08-22
Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile injectable drugs, including Kenalog-40, because FDA testing found microorganisms and fungal growth in the production clean room.
Product
KENALOG-40** (MDV 10ML VIAL) 40MG/ML INJECTABLE 50 ML (1 PRODUCT)
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…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1595-2012·2012-08-22
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
PAPAVERINE/PHENTOLAMINE/ATROPINE NS 3.6MG/0.4MG/0.04MG INJECTABLE 13 ML (1 PRODUCT)
Category
Drug
Distribution
Distributed nationwide
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

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11651–11675 of 11827