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

11801–11825 of 11860

SevereFDA (Drugs)·D-1548-2012·2012-08-22
Franck's Lab Recalls Iohexol Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling 19 units of Iohexol injectable sterile drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
IOHEXOL 200MG IODINE/ML INJECTABLE 120 ML 300 ML 50 ML 600 ML 72 ML; IOHEXOL, 4ML VIAL 240MG IODINE/ML INJECTABLE 200 ML; IOHEXOL, 3ML VIAL 300MG IODINE/ML INJECTABLE 180 ML 600 ML 90 ML 900 ML (10 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1594-2012·2012-08-22
Franck's Lab Recalls Sterile Papaverine and Alprostadil Injectable Drugs
Franck's Lab Inc. is recalling sterile papaverine and alprostadil injectables distributed between November 2011 and May 2012 due to microbial contamination found in the clean room.
Product
PAPAVERINE/ALPROSTADIL 30MG/10MCG/ML INJECTABLE 10 ML; PAPAVERINE/ALPROSTADIL 30MG/15MCG/ML INJECTABLE 10 ML (2 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1643-2012·2012-08-22
Franck's Lab Recalls Sterile Injectable Water Due to Contamination
Franck's Lab Inc. is recalling sterile injectable water products distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.
Product
WATER BACT STERILE - (25X30ML)*** INJECTABLE 30 ML 750 MLS; WATER STERILE - USP (25X10ML)* INJECTABLE 10 ML 10 MLS 100 ML 100 MLS 1000 ML…
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-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%…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1537-2012·2012-08-22
Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile hyaluronidase/methylprednisolone acetate injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room.
Product
HYALURONIDASE/METHYLPREDNISOLONE ACETATE, P.F. 37.5U/20MG/ML INJECTABLE 20 ML (1 PRODUCT)
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-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-1536-2012·2012-08-22
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 and fungal growth in the clean room.
Product
HYALURONIDASE / LIDOCAINE / BUPICAVAINE 7.1U/9.5MG/3.5MG/ML INJECTABLE 210 ML, 525 ML, 630 ML; HYALURONIDASE/LIDOCAINE/EPI/BUPIVICAINE INJECTABLE 32 ML, 64 ML (5 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1625-2012·2012-08-22
Recall of Sterile Thiamine HCL Injectable Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile Thiamine HCL injectable products because FDA sampling found microorganisms and fungal growth in the preparation clean room.
Product
THIAMINE HCL 100MG/ML INJECTABLE 300 ML 360 ML 450 ML (3 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1527-2012·2012-08-22
Franck's Lab Recalls Sterile G-C-P Solutions Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile G-C-P solutions because FDA testing found microorganisms and fungal growth in the clean room where the drugs were prepared.
Product
G-C-P 0.1%/0.1%/0.05% SOLUTION 250 ML, 250 MLS, 500 ML (3 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1610-2012·2012-08-22
Franck's Compounding Lab Recalls Sterile Injectable Drugs Due to Sterility Concerns
Franck's Compounding Lab is recalling 110 units of QUADMIX injectable drugs because FDA testing found microorganisms and fungal growth in the facility's clean room.
Product
QUADMIX 12MG/1MG/10MCG/150MCG/ML INJECTABLE 10 ML; QUADMIX 15MG/0.5MG/5MCG/100MCG/ML INJECTABLE 10 ML; QUADMIX 30MG/0.5MG/5MCG/100MCG/ML INJECTABLE 10 ML; QUADMIX 30MG/1MG/10MCG/100MCG/ML INJECTABLE 1 ML 10 ML…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1541-2012·2012-08-22
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 sampling found microorganisms in the production clean room.
Product
HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1500MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% SODIUM CHLORIDE) 50MG/500MCG/7.5MG/ML I 18 ML (3 DIFFEENT…
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-1450-2012·2012-08-22
Franck's Lab Recalls Acyclovir Ophthalmic Products Due to Sterility Concerns
Franck's Lab Inc. is recalling Acyclovir Ophthalmic 3% Ointment and Solution because FDA testing found microorganisms in the production clean room.
Product
ACYCLOVIR OPHTHALMIC 3% OINTMENT 5 GM; ACYCLOVIR OPHTHALMIC 3% SOLUTION 5 ML (2 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1618-2012·2012-08-22
Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.
Product
SODIUM BICARBONATE 4% INJECTABLE 10 ML 5 ML; SODIUM BICARBONATE 8.4% INJECTABLE 150 ML 50 ML 5000 ML; SODIUM BICARBONATE, 50ML SDV** 8.4% (1MEQ/ML) INJECTABLE 100 MLS 250 ML; SODIUM BICARBONATE, MDV 8.4% INJECTABLE 100 ML 150 ML 200 ML; SODIUM CHLORIDE…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1567-2012·2012-08-22
Franck's Lab Recalls Sterile L-Tryptophan Injectable Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile L-Tryptophan injectable products distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
L-TRYPTOPHAN 15MG/ML INJECTABLE 60 ML (1 PRODUCT)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1488-2012·2012-08-22
Franck's Lab Recalls Sterile Cyanocobalamin Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile cyanocobalamin (Vitamin B12) injectables because FDA sampling found microorganisms and fungal growth in the clean room where the products were prepared.
Product
CYANOCOBALAMIN (VIT B12 ) 1,000MCG/ML INJECTABLE 1 ML, 10 ML, 100 ML, 12 ML, 120 ML, 15 ML, 150 ML, 180 ML, 2 ML, 200 ML, 3 ML, 30 ML, 300 ML, 32 ML, 4 ML, 5 ML, 6 ML, 60 ML, 90 ML; CYANOCOBALAMIN **1000MCG/ML INJECTABLE 1000MCG/ML INJECTABLE 30 ML; CYANOCOBALAMIN*** (25X10ML…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1600-2012·2012-08-22
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
PHENYLEPHRINE/TROPICAMIDE (P.F.) SOLUTION 2.5%/1% OPHTHALMIC 5 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-1522-2012·2012-08-22
Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling four sterile injectable drug products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Product
FORMIX 100MCG / 30MG / 1MG INJECTABLE 10 ML, 10 MLS, 5 ML; FORMIX 100MCG / 30MG / 2MG INJECTABLE 10 ML (4 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1553-2012·2012-08-22
Labetalol Hydrochloride Injectable Recalled for Sterility Assurance Issues
Franck's Lab Inc. is recalling Labetalol Hydrochloride 5mg/mL injectable products due to microorganisms and fungal growth found in the clean room.
Product
LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE 100 ML 80 ML (2 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1475-2012·2012-08-22
Franck's Lab Recalls Sterile Intrathecal Bupivacaine and Hydromorphone Mixtures
Franck's Lab Inc. is recalling six sterile intrathecal drug mixtures due to microbial contamination found in the clean room where they were prepared.
Product
BUPIVACAINE/HYDROMORPHONE, P.F. 15MG/40MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 22MG/30MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/20MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/25MG/ML INTRATHECAL 18 ML…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1562-2012·2012-08-22
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
LIDOCAINE/SODIUM BICARBONATE/HEPARIN IRRIGATION 10.6MG/16.8MG/2667U/ML SOLUTIO 90 ML (1 PRODUCT)
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…
Category
Drug
Distribution
Distributed nationwide

How to read this listing

Filters

11801–11825 of 11860