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

17626–17650 of 17807

SevereFDA (Drugs)·D-1466-2012·2012-08-22
Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling 448 units of BIMIX sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.
Product
BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG / 5MG INJECTABLE 10 ML; BIMIX 9MG / 0.25MG INJECTABLE 10 ML, 5 ML; BIMIX 15MG / 1MG INJECTABLE 10 ML; BIMIX 18MG / 0.5MG INJECTABLE 10 ML, 5 ML; BIMIX 18MG / 1MG INJECTABLE 5 ML; BIMIX 20MG / 0.75MG INJECTABLE 5 ML…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1602-2012·2012-08-22
Franck's Lab Recalls Pilocarpine Ophthalmic Products Due to Sterility Concerns
Franck's Lab Inc. is recalling specific Pilocarpine HCL ophthalmic products because FDA testing found microorganisms and fungal growth in the facility's clean room.
Product
PILOCARPINE HCL P.F IN B.S.S OPHTHALMIC 1% INJECTABLE 36 ML; PILOCARPINE HCL SOLUTION 0.5% OPHTHALMIC 30 ML; PILOCARPINE HCL SOLUTION (PF) 0.5% OPHTHALMIC 30 ML (3 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1469-2012·2012-08-22
Franck's Lab Recalls Budesonide Nasal Irrigation Due to Sterility Concerns
Franck's Lab Inc. is recalling two units of Budesonide nasal irrigation solution because FDA testing found microorganisms in the production clean room.
Product
BUDESONIDE (P.F) NASAL IRRIGATION 0.5MG/500ML SOLUTION 1000 ML; BUDESONIDE (P.F) NASAL IRRIGATION 0.6MG/50ML SOLUTION 1500 ML (2 DIFFERENT UNITS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1454-2012·2012-08-22
Franck's Compounding Lab Recalls Sterile Amikacin Drugs Due to Contamination
Franck's Compounding Lab is recalling sterile Amikacin drugs because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.
Product
AMIKACIN P. F. 250MG/ML INJECTABLE 2 ML,4 ML; AMIKACIN SULFATE**** 4ML SDV 250MG/ML INJECTABLE 40 ML; AMIKACIN SULFATE, LYOPHILIZED 4MG VIAL INJECTABLE 1 KIT,1 VIAL, 2 KIT, 2 KITS, 2 VIAL, 4 KIT, 4 VIAL; AMIKACIN SULFATE, LYOPHILIZED, OPHTHALMIC KIT 4MG VIAL INJECTABLE 1 KIT, 2…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1471-2012·2012-08-22
Franck's Lab Recalls Sterile Intrathecal Drug Mixtures Due to Contamination
Franck's Lab Inc. is recalling sterile intrathecal drug mixtures because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.
Product
BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 20MG/400MCG/2MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 7.5MG/1.5MCG/50MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 5MG/500MCG/50MG/ML INTRATHECAL (4 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1590-2012·2012-08-22
Franck's Lab Recalls Sterile Oxytocin Injectable Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile oxytocin injectable products distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the manufacturing clean room.
Product
OXYTOCIN 10UNITS/ML INJECTABLE 25 ML; OXYTOCIN**(25X1ML) 10U/ML INJECTABLE 25 MLS (2 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1490-2012·2012-08-22
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 testing found microorganisms in the clean room.
Product
CYCLOPENT/KETOROLAC/PHENYLEPH/TROPICAMIDE 1%/0.5%/2.5%/1% OPHTHALMIC 70 ML (1 PRODUCT)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1566-2012·2012-08-22
Franck's Lab Recalls Lorazepam Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling Lorazepam 2mg/mL injectable products because FDA testing found microorganisms and fungal growth in the facility's clean room.
Product
LORAZEPAM 2MG/ML INJECTABLE 10 ML 20 ML 200 ML (3 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1587-2012·2012-08-22
Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile injectable drugs, including NADH-FFC, because FDA testing found microorganisms and fungal growth in the facility's clean room.
Product
NADH-FFC 10 MG/CC INJECTABLE 10 ML (1 PRODUCT)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1533-2012·2012-08-22
Recall of Sterile Hyaluronic Acid Sodium Salt Injectable Drugs
Franck's Lab Inc. is recalling sterile hyaluronic acid sodium salt injectable drugs due to the presence of microorganisms and fungal growth in the clean room.
Product
HYALURONIC ACID SODIUM SALT 10MG/ML INJECTABLE 100 ML, 20 ML; HYALURONIC ACID SODIUM SALT, P.F. 20MG/ML INJECTABLE 500 ML (3 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1623-2012·2012-08-22
Franck's Lab Recalls Sterile Tetracosactide Acetate Injectable Due to Contamination
Franck's Lab Inc. is recalling sterile Tetracosactide Acetate injectables distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
TETRACOSACTIDE ACETATE (COSYNTROPIN) 0.25MG/ML INJECTABLE 1 ML (1 PRODUCT)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1579-2012·2012-08-22
Franck's Compounding Lab Recalls Sterile Injectable Drugs Due to Contamination
Franck's Compounding Lab 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
MIC - COMBO WITH METHYLCOBALAMIN 0.8/1.6/1.6/0.0001/0.03% INJECTABLE 10 ML 150 ML 30 ML; MIC COMBO + CHORIONIC GONADOTROPIN + B12 500U/40MCG/ML (125U/10MCG/0.25ML) INJEC 6 ML; MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED 10,000 UNIT VIAL INJECTABLE 1 VIAL…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1452-2012·2012-08-22
Franck's Lab Recalls Sterile Alprostadil Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile alprostadil drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML; ALPROSTADIL 15MCG/ML INJECTABLE 5 ML; ALPROSTADIL 20MCG/ML INJECTABLE 10 ML, 10 MLS, 20 ML, 3 ML, 30 ML, 4 ML, 40 ML, 5 ML, 6 ML; ALPROSTADIL 24MCG/ML INJECTABLE 6 ML; ALPROSTADIL 25MCG/ML INJECTABLE 10…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1502-2012·2012-08-22
Franck's Lab Recalls Sterile Diclofenac Sodium Injectable Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile diclofenac sodium injectables distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the clean room.
Product
DICLOFENAC SODIUM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 500MCG/0.1ML INJECTABLE 0.5 ML, 2 ML, 4 ML (3 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1495-2012·2012-08-22
Franck's Lab Recalls Dapiprazole Ophthalmic Products Due to Sterility Concerns
Franck's Lab Inc. is recalling Dapiprazole ophthalmic products because FDA sampling found microorganisms in the clean room where they were prepared.
Product
DAPIPRAZOLE OPHTHALMIC 0.5% SOLUTION 10 ML; DAPIPRAZOLE, LYOPHILIZED, OPHTHALMIC KIT 0.5% POWDER 1 KIT, 10 KIT, 2 KIT, 3 KIT, 4 KIT, 6 KIT (7 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1621-2012·2012-08-22
Franck's Compounding Lab Recalls Sterile Injectable Drugs Due to Contamination
Franck's Compounding Lab 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
TESTOSTERONE CYP/ESTRADIOL CYP 50MG/2MG/ML INJECTABLE 5 ML; TESTOSTERONE CYPIONATE 50MG/ML INJECTABLE 12 ML 2.5 ML (4 DIFFERENT PRODUCTS) 5 ML; TESTOSTERONE PROPIONATE 200MG/ML INJECTABLE 10 ML
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1538-2012·2012-08-22
Recall of Hydrochloric Acid Injection Due to Sterility Concerns
Franck's Lab Inc. is recalling Hydrochloric Acid Injection products because FDA testing found microorganisms in the production clean room.
Product
HYDROCHLORIC ACID INJECTION 2MG/ML INJECTABLE 400 ML, 60 ML (2 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
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

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17626–17650 of 17807