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 11860

SevereFDA (Drugs)·D-1608-2012·2012-08-22
Franck's Lab Recalls Sterile Progesterone Injections Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile progesterone injections distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the production clean room.
Product
PROGESTERONE AQUEOUS 2MG/ML INJECTABLE 3 ML; PROGESTERONE IN COTTONSEED OIL 50MG/ML INJECTABLE 30 ML; PROGESTERONE IN SESAME OIL 100MG/ML INJECTABLE 200 ML; PROGESTERONE IN SESAME OIL 150MG/ML INJECTABLE 1000 ML; PROGESTERONE IN SESAME OIL 50MG/ML INJECTABLE 10 MLS…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1447-2012·2012-08-22
Franck's Lab Recalls Acetazolamide Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling Acetazolamide injectable vials because FDA sampling found microorganisms in the clean room where they were prepared.
Product
ACETAZOLAMIDE, LYOPHILIZED 500MG INJECTABLE10 VIAL, 4 VIAL, 5 VIAL, 6 VIAL, 8 VIAL (5 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1485-2012·2012-08-22
Franck's Lab Recalls Cisplatin Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling Cisplatin 1mg/ml injectable products because FDA sampling found microorganisms in the clean room where they were prepared.
Product
CISPLATIN 1MG/ML INJECTABLE 1000 ML, 2000 ML (2 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1547-2012·2012-08-22
Franck's Lab Recalls Sterile Insulin Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile insulin products distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
INSULIN, LO-DOSE (FROM HUMALOG) 10 UNITS/ML INJECTABLE 10 ML (1 PRODUCT)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1552-2012·2012-08-22
Recall of Sterile Ketorolac Tromethamine Injectable Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile ketorolac tromethamine injectable products because environmental sampling found microorganisms and fungal growth in the clean room where they were prepared.
Product
KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE 10 ML 24 ML 500 ML; KETOROLAC TROMETHAMINE 60MG/ML INJECTABLE 48 ML; KETOROLAC TROMETHAMINE, 1ML SDV**25X1ML 30MG/ML INJECTABLE 50 ML 75 ML; KETOROLAC TROMETHAMINE, P.F. 60MG/ML INJECTABLE 10 ML (7 DIFFERENT…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1501-2012·2012-08-22
Franck's Lab Recalls Sterile Diazepam Injectable Drugs Due to Contamination
Franck's Lab Inc. is recalling sterile diazepam injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Product
DIAZEPAM (IM/IV) 1MG/ML INJECTABLE 40 ML, 60 ML; DIAZEPAM (IM/IV) 5MG/ML INJECTABLE 2 ML, 20 ML, 300 ML; DIAZEPAM 2.5MG/ML INJECTABLE 40 ML; DIAZEPAM 2MG/ML INJECTABLE 100 ML, 50 ML (8 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1460-2012·2012-08-22
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 testing found microorganisms in the production clean room.
Product
BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 1000MCG/7.5MG/1000MCG/50MG/ML INTR 40 ML; BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 50MCG/2MG/200MCG/50MG/ML INTRATHEC 18 ML; BACLOFEN/CLONIDINE/BUPIVACAINE/MORPHINE, P.F. 500MCG/1/7.5/50MG/ML INTRATHECAL 40 ML (3 DIFFERENT…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1598-2012·2012-08-22
Franck's Lab Recalls Sterile Ophthalmic Solutions Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile ophthalmic solutions because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.
Product
PHENYLEPH/DICLOF/TROPIC/PROPARAC/POVIDONE IODINE SOL. 10%/0.1%/1%/0.5%/5% OPHTHA 10 ML 2 ML 20 ML 3 ML (4 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1457-2012·2012-08-22
Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling 19 units of sterile injectable drugs, including ascorbic acid and vitamin blends, because FDA sampling found microorganisms in the production clean room.
Product
ASCORBIC ACID (BEET SOURCE) 500MG/ML INJECTABLE 100 ML, 150 ML, 200 ML, 250 ML, 300 ML, 400 ML, 500 ML, 60 ML; ASCORBIC ACID (CORN SOURCE) 500MG/ML INJECTABLE 100 ML; ASCORBIC ACID, 50ML SDPF, VIAL** 500MG/ML INJECTABLE 50 ML, 500 ML…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1601-2012·2012-08-22
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/PROPARACAINE SOLUTION 2.5%/1%/0.5% OPHTHALMIC 120 ML 25 ML 30 ML 5 ML 90 ML (5 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1619-2012·2012-08-22
Franck's Lab Recalls Strontium Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling Strontium 1 mg/mL Injectable due to microorganisms found in the clean room where sterile products were prepared.
Product
STRONTIUM 1 MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1584-2012·2012-08-22
Franck's Lab Recalls Sterile Molybdenum Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling sterile molybdenum injectable products because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.
Product
MOLYBDENUM 250MCG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1515-2012·2012-08-22
Franck's Lab Recalls Sterile Estradiol Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling 72 units of sterile estradiol products distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.
Product
ESTRADIOL 25MG PELLETS 1 PELLET, 15 PEL, 15 PELLET, 2 PELLET, 2 TAB, 3 PELLET, 4 PELLET, 6 PELL, 6 PELLET; ESTRADIOL 50MG PELLETS 1 PELELT, 1 PELLET, 4 PELLET, 6 PELLET; ESTRADIOL CYPIONATE 5MG/ML INJECTABLE 5 ML; ESTRADIOL VALERATE IN COTTONSEED OIL 40 MG/ML INJECTABLE 10 ML…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1526-2012·2012-08-22
Franck's Lab Recalls Sterile Ganciclovir Injectable Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile Ganciclovir injectable syringes because FDA testing found microorganisms and fungal growth in the clean room where the drugs were prepared.
Product
GANCYCLOVIR, SDPF - (30G, 1/2" SYRINGE) 20MG/ML INJECTABLE 1 ML (1 PRODUCT)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1462-2012·2012-08-22
Franck's Lab Recalls Sterile Intrathecal Baclofen and Morphine Mixtures
Franck's Lab Inc. is recalling sterile intrathecal Baclofen/Morphine mixtures distributed between November 2011 and May 2012 due to microbial contamination found in the clean room.
Product
BACLOFEN/MORPHINE, P.F. 1,000MCG/25MG/ML INTRATHECAL 18 ML; BACLOFEN/MORPHINE, P.F. 1,500MCG/1.5MG/ML INTRATHECAL 40 ML; BACLOFEN/MORPHINE, P.F. 2,000MCG/25MG/ML INTRATHECAL 40 ML (3 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1606-2012·2012-08-22
Franck's Lab Recalls Prednisolone Acetate Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling Prednisolone Acetate 10mg/ml Injectable because FDA testing found microorganisms in the production clean room.
Product
PREDNISOLONE ACETATE 10MG/ML INJECTABLE 10 MLS (1 PRODUCT)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1474-2012·2012-08-22
Franck's Lab Recalls Sterile Bupivacaine and Fentanyl Intrathecal Solutions
Franck's Lab Inc. is recalling sterile bupivacaine and fentanyl intrathecal solutions due to microbial contamination found in the clean room.
Product
BUPIVACAINE/FENTANYL IN SODIUM CHLORIDE 0.9% P. F. 30 MG/200 MCG/ML INTRATHECAL 40 ML (1 PRODUCT)
Category
Drug
Distribution
Distributed nationwide
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

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11651–11675 of 11860