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 deaths or serious injuries are reported, 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

8551–8575 of 8593

SevereFDA (Drugs)·D-1556-2012·2012-08-22
Franck's Lab Recalls Sterile Levofloxacin Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling sterile levofloxacin injectable solutions because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Product
LEVOFLOXACIN, P.F. (PREMIXED SOLUTION) 5MG/ML INJECTABLE 1200 ML 500 ML 700 ML 800 ML LEVOFLOXACIN, P.F. 25MG/ML(500MG/20ML) INJECTABLE 300 ML 500 ML (6 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1588-2012·2012-08-22
Franck's Lab Recalls Sterile Injectable Drugs Due to Contamination
Franck's Lab Inc. is recalling sterile injectable drugs, including nandrolone decanoate, after FDA sampling found microorganisms and fungal growth in the clean room.
Product
NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE 1 ML
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1555-2012·2012-08-22
Franck's Compounding Lab Recalls Sterile Leucovorin Vials Due to Microbial Contamination
Franck's Compounding Lab is recalling sterile leucovorin vials because FDA environmental sampling found microorganisms and fungal growth in the clean room where the products were prepared.
Product
LEUCOVORIN, LYOPHILIZED 100 MG VIAL INJECTABLE 1 VIAL 10 VIAL 100 VIAL 2 VIAL 24 VIAL 30 VIAL 50 VIAL 60 VIAL 76 VIAL; LEUCOVORIN, LYOPHILIZED 350 MG VIAL INJECTABLE 10 VIAL 15 VIAL 20 VIAL 22 VIAL 28 VIAL 30 VIAL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1603-2012·2012-08-22
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
POTASSIUM CHLORIDE ***(30ML VIAL) 2MEQ/ML INJECTABLE 750 MLS; POTASSIUM CHLORIDE IN NORMAL SALINE 40MEQ/100ML (400MEQ/L) INJECTABLE 1000 ML; POTASSIUM CHLORIDE**(25X20ML) 2MEQ/ML INJECTABLE 500 ML; POTASSIUM PHOSPHATE 4.4MEQ/ML (3MMOL/ML) INJECTABLE 300 ML 750 ML (5 DIF
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 V
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-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 DI
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1458-2012·2012-08-22
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 in the clean room.
Product
ATROPINE SULFATE 0.4MG/ML INJECTABLE 12 ML, 2 ML, 20 ML, 24 ML, 25 ML, 3 ML; ATROPINE/EPINEPHRINE/ BSS 0.02MG/0.1MG/ML INJECTABLE 10 ML, 5 ML (8 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1609-2012·2012-08-22
Franck's Lab Recalls Pyridoxine Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling Pyridoxine 100mg/mL Injectable products because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.
Product
PYRIDOXINE 100MG/ML INJECTABLE 150 ML 180 ML 300 ML 360 ML 450 ML (5 DIFFERENT PRODUCTS)
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 PRODU
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 M
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-1627-2012·2012-08-22
Franck's Lab Recalls Sterile Tobramycin Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile tobramycin drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
TOBRAMYCIN 1.4% (14MG/ML) OPHTHALMIC 15 ML 3 ML 7 ML; TOBRAMYCIN SOLUTION** 0.3% OPHTHALMIC 30 MLS 5 MLS; TOBRAMYCIN SULFATE** (25X2ML) 80MG/2ML INJECTABLE 100 ML 150 ML 50 MLS; TOBRAMYCIN/AMPHOTERICIN-B/BUDESONIDE, STERILE 125MG/5MG/0.6MG/5ML NASO-NEB 70
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-1615-2012·2012-08-22
Franck's Lab Recalls Sterile Selenium Injectable Due to Contamination
Franck's Lab Inc. is recalling sterile selenium injectable products because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.
Product
SELENIUM 200MCG/ML INJECTABLE 150 ML 30 ML 60 ML (3 DIFFERENT PRODUCTS)
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-1500-2012·2012-08-22
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 in the clean room.
Product
DEXTROSE/PROCAINE HCL P.F. 12%/1% INJECTABLE 400 ML ( 1 PRODUCT)
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-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-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-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
CriticalFDA (Drugs)·D-1444-2012·2012-08-15
Hospira Recalls Overfilled Hydromorphone Hydrochloride Prefilled Cartridges
Hospira Inc. is recalling 223,750 units of Hydromorphone Hydrochloride Injection because some prefilled cartridges contain more than the labeled 1 mL volume.
Product
HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1446-2012·2012-08-15
Nephron Recalls Albuterol Sulfate Inhalation Solution Due to Sterility Concerns
Nephron Pharmaceuticals is recalling Albuterol Sulfate Inhalation Solution because the company cannot ensure the product is sterile. The recall affects 56,028 cartons distributed nationwide and in Puerto Rico.
Product
ALBUTEROL SULFATE — ALBUTEROL SULFATE (ALBUTEROL SULFATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1428-2012·2012-08-08
Zydus Recalls Metformin Tablets Due to Foreign Substance Presence
Zydus Pharmaceuticals is recalling 1,176 bottles of Metformin Hydrochloride 1000 mg tablets because a pharmacist reported brown specks and metal shavings on the tablets.
Product
Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-030-10.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1434-2012·2012-08-08
Dr. Reddy's Recalls Amlodipine and Benazepril Capsules Due to Foreign Tablets
Dr. Reddy's is recalling Amlodipine Besylate and Benazepril Hydrochloride capsules because bottles were mislabeled and contained foreign Ciprofloxacin tablets.
Product
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide

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8551–8575 of 8593