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

8101–8125 of 17974

SevereFDA (Drugs)·D-1075-2019·2019-04-10
Losartan Potassium Tablets Recalled Due to Impurity Detection
Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 50 mg, because an impurity was detected. The recall covers 179,544 bottles distributed in Arizona, Indiana, and Tennessee.
Product
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 630
Category
Drug
Distribution
3 states
HighFDA (Drugs)·D-1077-2019·2019-04-10
Morphine Sulfate API Recalled for Microbial Contamination Out of Specification
Johnson Matthey Inc. is recalling Morphine Sulfate USP Milled API due to bioburden out of specification results.
Product
Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1069-2019·2019-04-10
Pfizer Recalls Cleocin Phosphate Injection Due to Impurity Failures
Pfizer is recalling specific lots of Cleocin Phosphate injection because high levels of impurities were found at the 24-month time point.
Product
CLEOCIN PHOSPHATE — CLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1071-2019·2019-04-10
Pfizer Recalls Clindamycin Injection Due to Impurity Specification Failures
Pfizer is recalling specific lots of Clindamycin Injection because high out-of-specification impurities were found at the 24-month time point.
Product
Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC 47781-620-94
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1079-2019·2019-04-10
KRS Global Biotechnology Recalls NORepinephrine IV Bags Due to Labeling Error
KRS Global Biotechnology is recalling 433 bags of NORepinephrine 4 mg in 5% Dextrose due to a label mix-up. The product was distributed nationwide.
Product
NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321674481
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1074-2019·2019-04-10
Jubilant Cadista Recalls Pantoprazole Sodium Tablets Due to Discoloration
Jubilant Cadista Pharmaceuticals is recalling 12,960 bottles of Pantoprazole Sodium Delayed-Release Tablets due to dark brown discoloration on the tablet edges.
Product
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1072-2019·2019-04-10
Pfizer Recalls Clindamycin Injection Vials Due to Impurity Failures
Pfizer is recalling specific lots of Clindamycin Injection due to high out-of-specification impurity results at the 24-month time point.
Product
Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1076-2019·2019-04-10
Pacific Compounding Recalls Cefuroxime Injection Due to Particulate Matter
Pacific Compounding Pharmacy is recalling one lot of Cefuroxime injection because FDA analysis found rubber stopper fragments in the product.
Product
Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-1070-2019·2019-04-10
Pfizer Recalls Clindamycin Injection Vials Due to Impurity Failures
Pfizer is recalling specific lots of Clindamycin Injection because high levels of impurities were found at the 24-month time point.
Product
Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1078-2019·2019-04-10
KRS Global Biotechnology Recalls Repinephrine IV Bags Due to Labeling Error
KRS Global Biotechnology is recalling 190 bags of Repinephrine 16 mg IV solution due to a label mix-up. The product was distributed nationwide.
Product
NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag, Rx only, KRS Global Biotechnology: 791 Park of Commerce Blvd., Boca Raton, FL 33487. NDC 3321678343
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1080-2019·2019-04-10
Akorn Recalls Nystatin Oral Suspension Due to Unknown Impurity
Akorn, Inc. is recalling Nystatin Oral Suspension because an unknown impurity was detected during stability testing. The affected product was distributed in Arkansas and Mississippi.
Product
Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16
Category
Drug
Distribution
2 states
LowFDA (Drugs)·D-1068-2019·2019-04-10
Pfizer Recalls Cleocin Phosphate Injection Due to Impurity Failures
Pfizer is recalling specific lots of Cleocin Phosphate injection because high out-of-specification impurity levels were detected at the 24-month time point.
Product
CLEOCIN PHOSPHATE — CLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1067-2019·2019-04-10
Pfizer Recalls Cleocin Phosphate Injection Due to Impurity Failures
Pfizer is recalling specific lots of Cleocin Phosphate injection because high out-of-specification impurities were detected at the 24-month time point.
Product
CLEOCIN PHOSPHATE — CLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1085-2019·2019-04-03
Blue Fusion Capsules Recalled for Undeclared Prescription Ingredients
Ata International Inc is recalling Blue Fusion Capsules because FDA analysis found undeclared prescription ingredients, including Sildenafil and Tadalafil.
Product
Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riverside, CA 92507, UPC 7 48252 66460 0
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1057-2019·2019-04-03
Lupin Recalls Fayosim Tablets Due to Impurity Test Failures
Lupin Pharmaceuticals is recalling specific lots of Fayosim tablets because they failed impurity specifications during stability testing.
Product
Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-86
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1062-2019·2019-04-03
Ecolab Moisturizing Gel Hand Sanitizer Recalled for Chemical Contamination
Ecolab is recalling 30 units of Moisturizing Gel Hand Sanitizer due to low levels of substituted benzene compounds found after complaints of malodor.
Product
ECOLAB — ECOLAB (ETHYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1056-2019·2019-04-03
Allergan Recalls 72 Bottles of Combigan Eye Drops for cGMP Deviations
Allergan is voluntarily recalling 72 bottles of Combigan ophthalmic solution in Tennessee due to current Good Manufacturing Practice (cGMP) deviations.
Product
COMBIGAN — COMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-1063-2019·2019-04-03
Ecolab Recalls Quick-Care Foam Hand Sanitizer Due to Chemical Contamination
Ecolab is recalling 67 units of Quick-Care Foam Hand Sanitizer due to low levels of substituted benzene compounds found after malodor complaints.
Product
Quick-Care Foam Hand Sanitizer (Ethyl alcohol 62%), 45 mL (1.5 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-491-85
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1061-2019·2019-04-03
Ecolab Recalls Advanced Gel Hand Sanitizer Due to Chemical Contamination
Ecolab is recalling Advanced Gel Hand Sanitizer because low levels of substituted benzene compounds were found after complaints of malodor.
Product
ADVANCED GEL HAND SANITIZER — ADVANCED GEL HAND SANITIZER (ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1064-2019·2019-04-03
Ecolab Recalls Express Gel Hand Sanitizer Due to Chemical Contamination
Ecolab is recalling 105 bottles of Express Gel Hand Sanitizer due to low levels of substituted benzene compounds found after malodor complaints.
Product
Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102. NDC 47593-502-49
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1060-2019·2019-04-03
Ecolab Gel Hand Sanitizer Recalled for Chemical Contamination
Ecolab Inc. is recalling specific lots of Ecolab Gel Hand Sanitizer due to the presence of low levels of substituted benzene compounds.
Product
ECOLAB — ECOLAB (ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1058-2019·2019-04-03
Ingenus Recalls Diclofenac Sodium Topical Solution Due to Leaking Bottles
Ingenus Pharmaceuticals is recalling 29,435 bottles of Diclofenac Sodium Topical Solution because some bottles were found leaking.
Product
Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1017-2019·2019-03-27
Advanced Pharma Recalls Fentanyl Injectable Solution Due to Sterility Concerns
Advanced Pharma Inc. is recalling 360 bags of fentanyl injectable solution nationwide due to a lack of assurance of sterility.
Product
fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag, NDC: 42852-210-10 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1038-2019·2019-03-27
Aurobindo Recalls Valsartan Tablets Due to NDEA Impurity
Aurobindo Pharma USA is recalling specific lots of Valsartan 80 mg tablets because FDA analysis confirmed trace amounts of the impurity N-nitrosodiethylamine (NDEA).
Product
VALSARTAN — VALSARTAN (VALSARTAN)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1019-2019·2019-03-27
Advanced Pharma Recalls Midazolam Injectable Solution Due to Sterility Concerns
Advanced Pharma Inc. is recalling 1,125 bags of Midazolam Injectable Solution nationwide due to a lack of assurance of sterility.
Product
Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile single use bag, NDC: 42852-401-05 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Category
Drug
Distribution
Distributed nationwide

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8101–8125 of 17974