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

11751–11775 of 11860

SevereFDA (Drugs)·D-1453-2012·2012-08-22
Recall of Sterile Alteplase Syringes Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile alteplase syringes distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
ALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML; ALTEPLASE, SDPF - (0.15ML LL SYRINGE, NO NEEDLE) 100MCG/ML (10MCG/0.1ML) INJECTA 0.15 ML, 0.3 ML; ALTEPLASE, SDPF - (0.1ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.1 ML, 0.2 ML, 0.3 ML; ALTEPLASE…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1596-2012·2012-08-22
Recall of Penicillin G Potassium Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling Penicillin G Potassium Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.
Product
PENICILLIN G POTASSIUM 10,000U/ML INJECTABLE 1 ML (1 PRODUCT)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1616-2012·2012-08-22
Franck's Lab Recalls Sermorelin Acetate Due to Sterility Concerns
Franck's Lab Inc. is recalling Sermorelin Acetate products because FDA sampling found microorganisms in the clean room where they were prepared.
Product
SERMORELIN ACETATE, LYOPHILIZED 6MG KIT 1 KIT 2 KIT; SERMORELIN ACETATE, LYOPHILIZED 6MG VIAL 2 VIAL; SERMORELIN ACETATE, LYOPHILIZED 9MG KIT 1 KIT 3 KIT 6 KIT; SERMORELIN ACETATE, LYOPHILIZED…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1575-2012·2012-08-22
Franck's Lab Recalls Sterile Methylprednisolone Acetate Injectable Due to Contamination
Franck's Lab Inc. is recalling sterile methylprednisolone acetate injectable products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Product
METHYLPREDNISOLONE ACETATE 100MG/ML INJECTABLE 50 ML; METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE 1 ML 30 ML 6 ML 60 ML (5 DIFFERENT PRODUCTS)
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…
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-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-1523-2012·2012-08-22
Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling specific sterile injectable drugs because FDA testing found microorganisms and fungal growth in the facility's clean room.
Product
FORSKOLIN/PAPAVARINE/PHENTOLAMINE 200MCG/40MG/3MG/ML INJECTABLE 5 ML; FORSKOLIN/PAPAVARINE/PHENTOLAMINE/ALPROSTADIL 100MCG/30MG/1MG/30MCG/ML INJECTABL 10 ML; (2 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1511-2012·2012-08-22
Recall of Sterile Ophthalmic Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile ophthalmic drugs due to microbial contamination found in the clean room.
Product
EDETATE DISODIUM PF IN BSS 3% OPHTHALMIC 10 ML; EDETATE DISODIUM SOLUTION IN ARTIFICIAL TEARS 0.05% OPHTHALMIC 10 ML (2 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1467-2012·2012-08-22
Recall of Boron Injectable Due to Sterility Assurance Failure
Franck's Lab is recalling Boron 2mg/mL Injectable because FDA sampling found microorganisms in the clean room where sterile products were prepared.
Product
BORON 2MG/ML INJECTABLE 40 ML (2 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1463-2012·2012-08-22
Franck's Lab Recalls Sterile Sodium Chloride Vials Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile sodium chloride injectable vials because FDA testing found microorganisms and fungal growth in the clean room where the products were prepared.
Product
BACTERIOSTATIC SODIUM CHLORIDE 10ML VIAL** 0.9% INJECTABLE 10 ML, 10 MLS, 100 ML, 120, 20 MLS, 200 ML, 30 MLS, 40 ML, 50 ML, 50 MLS (10 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1644-2012·2012-08-22
Franck's Lab Recalls Zinc Chloride Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling Zinc Chloride 10mg/ml Injectable because FDA sampling found microorganisms and fungal growth in the clean room where sterile products were prepared.
Product
ZINC CHLORIDE 10MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1520-2012·2012-08-22
Franck's Lab Recalls Fluorouracil Sterile Ophthalmic and Injectable Solutions
Franck's Lab Inc. is recalling 14 units of sterile Fluorouracil products due to microbial contamination found in the clean room.
Product
FLUOROURACIL (5-FU) SOLUTION 5% OPHTHALMIC 100 ML; FLUOROURACIL (5-FU) SOLUTION IN ARTIFICIAL TEARS 1% OPHTHALMIC 15 ML; FLUOROURACIL (5-FU) SOLUTION, P.F. 0.001% (10MCG/ML) OPHTHALMIC 20 ML, 30 ML; FLUOROURACIL P.F. 5% INJECTABLE 1000 ML,500 ML, 600 ML; FLUOROURACIL SOLUTION…
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…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1464-2012·2012-08-22
Franck's Lab Recalls Sterile Bevacizumab Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile bevacizumab injectables and ophthalmic products distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/100MG/ML INJECTABLE 0.72 ML; BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/20MG/ML INJECTABLE 3 ML, 4.5 ML; BEVACIZUMAB & DXM, SDPF - (0.075ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECTABLE 0.225 ML…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1532-2012·2012-08-22
Franck's Lab Recalls Sterile Insulin Due to Microbial Contamination
Franck's Lab Inc. is recalling Humulin-R Insulin vials distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
HUMULIN-R INSULIN, 10ML VIAL** 100U/ML INJECTABLE 10 MLS (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-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-1636-2012·2012-08-22
Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile injectable drugs, including Ultra-Test, because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Product
ULTRA-TEST 200 (CYP 80%/PROP 20%) 200MG/ML INJECTABLE 1 ML 10 ML…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1504-2012·2012-08-22
Franck's Lab Recalls Sterile DMPS Injectable Drugs Due to Contamination
Franck's Lab Inc. is recalling sterile DMPS injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Product
DMPS 250MG/10ML INJECTABLE 20 ML, 30 ML; DMPS 50MG/ML (500MG/10ML) INJECTABLE 10 ML, 5 ML (4 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1585-2012·2012-08-22
Franck's Compounding Lab Recalls Morphine Sulfate Injectable Products
Franck's Compounding Lab is recalling 92 units of morphine sulfate injectable products due to a lack of assurance of sterility.
Product
MORPHINE SULFATE 2MG/ML INJECTABLE 10 ML; MORPHINE SULFATE MDV 10MG/ML INJECTABLE 10 ML 25 ML 30 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 50MG/ML INTRATHECAL 18 ML 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 15MG/ML INTRATHECAL 40 ML…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1503-2012·2012-08-22
Franck's Lab Recalls Sterile Diphenhydramine Injectable Due to Contamination
Franck's Lab Inc. is recalling sterile diphenhydramine injectable products because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.
Product
DIPHENHYDRAMINE 25MG/ML INJECTABLE 90 ML; DIPHENHYDRAMINE 50MG/ML INJECTABLE 10 ML, 100 ML, 108 ML, 120 MLS, 25 ML, 32 ML, 60 ML, 90 ML, 90 MLS; DIPHENHYDRAMINE, SDV, 25X1ML** 50MG/ML INJECTABLE 25 ML (11 DIFFERENT PRODUCTS)
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-1543-2012·2012-08-22
Franck's Lab Recalls Sterile Hydroxocobalamin Injections Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile Hydroxocobalamin injections because FDA testing found microorganisms and fungal growth in the production clean room.
Product
HYDROXOCOBALAMIN**(VIT B-12) 1000MCG/ML INJECTABLE 30 ML Injectable (4 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…
Category
Drug
Distribution
Distributed nationwide

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11751–11775 of 11860