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

16226–16250 of 18001

SevereFDA (Drugs)·D-332-2014·2013-12-18
Novartis Recalls Exforge HCT Physician Samples Due to Chemical Contamination
Novartis is recalling Exforge HCT physician sample bottles contaminated with Darocur 1173, a photocuring agent found in ink on shrink-wrap sleeves.
Product
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-326-2014·2013-12-18
Novartis Recalls Diovan and Other Tablets Due to Chemical Contamination
Novartis is recalling physician sample bottles of several prescription tablets, including Diovan, due to contamination with a photocuring agent.
Product
Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9359-07
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-344-2014·2013-12-18
Volcano Male Enhancement Liquid Recalled for Undeclared Pharmaceutical Ingredients
Myson Corporation is recalling Volcano Male Enhancement Liquid because it contains undeclared active pharmaceutical ingredients, making it an unapproved new drug.
Product
Volcano Male Enhancement Liquid, 2 FL OZ (60 ml) bottle, www.volcanoenhancement.com, DISTRIBUTED BY VOLCANO Long Beach, CA 90813, UPC 6 09613 85996 0.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-336-2014·2013-12-18
Novartis Recalls Stalevo Tablets Due to Chemical Contamination
Novartis is recalling Stalevo physician sample bottles contaminated with Darocur 1173, a photocuring agent found in ink.
Product
Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC #…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-335-2014·2013-12-18
Novartis Recalls Lescol XL Tablets Due to Chemical Contamination
Novartis is recalling Lescol XL tablets contaminated with Darocur 1173, a photocuring agent found in ink on shrink-wrap sleeves.
Product
Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-342-2014·2013-12-18
VistaPharm Recalls Phenytoin Oral Suspension Due to Container Defects
VistaPharm is recalling specific lots of Phenytoin Oral Suspension because a lidding defect caused the product to fail stability tests for assay and viscosity.
Product
Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-340-2014·2013-12-18
Novartis Recalls Tekturna HCT Physician Samples Due to Chemical Contamination
Novartis is recalling Tekturna HCT physician sample bottles due to contamination with Darocur 1173, a photo curing agent used in ink.
Product
Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-343-2014·2013-12-18
Oxcarbazepine Tablets Recalled for Potential Subpotency
Boehringer Ingelheim Roxane Inc. is recalling Oxcarbazepine Tablets, 150 mg, due to out-of-specification assay results and potential lower weight tablets.
Product
Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-329-2014·2013-12-18
Novartis Recalls Exforge Physician Samples Due to Chemical Contamination
Novartis is recalling Exforge physician sample bottles due to contamination with Darocur 1173, a photocuring agent used in ink.
Product
Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9490-07
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-331-2014·2013-12-18
Novartis Recalls Multiple Prescription Medications Due to Chemical Contamination
Novartis is recalling physician sample bottles of several prescription medications due to contamination with a photocuring agent found in ink.
Product
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-337-2014·2013-12-18
Novartis Recalls Physician Sample Tablets Due to Chemical Contamination
Novartis is recalling physician sample bottles of several prescription medications, including Tekturna, due to contamination with a photocuring agent.
Product
Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9485-07
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-327-2014·2013-12-18
Novartis Recalls Diovan and Other Tablets Due to Chemical Contamination
Novartis is recalling physician sample bottles of Diovan and other tablets because they were contaminated with Darocur 1173, a photocuring agent used in inks.
Product
Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9360-07
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-328-2014·2013-12-18
Novartis Recalls Exforge Physician Samples Due to Chemical Contamination
Novartis is recalling Exforge physician sample bottles due to contamination with Darocur 1173, a photocuring agent found in ink.
Product
Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9488-07
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-346-2014·2013-12-18
Lupin Recalls Ethambutol Hydrochloride Tablets Due to Impurity
Lupin Pharmaceuticals is recalling 4,896 bottles of Ethambutol Hydrochloride 400 mg tablets because of an out-of-specification impurity result.
Product
ETHAMBUTOL HYDROCHLORIDE — ETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-338-2014·2013-12-18
Novartis Recalls Tekturna Tablets Due to Chemical Contamination
Novartis is recalling Tekturna physician sample bottles contaminated with Darocur 1173, a photocuring agent found in ink.
Product
Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Produktions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9486-07
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-334-2014·2013-12-18
Novartis Recalls Exforge Physician Samples Due to Chemical Contamination
Novartis is recalling Exforge physician sample bottles due to contamination with Darocur 1173, a photocuring agent found in ink.
Product
Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9491-07
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-330-2014·2013-12-18
Novartis Recalls Physician Sample Blood Pressure Medications Due to Chemical Contamination
Novartis is recalling physician sample bottles of several blood pressure and cholesterol medications due to contamination with a photocuring agent used in packaging inks.
Product
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-339-2014·2013-12-18
Novartis Recalls Tekturna HCT Physician Samples Due to Chemical Contamination
Novartis is recalling physician sample bottles of Tekturna HCT and other medications due to contamination with Darocur 1173, a photo-curing agent.
Product
Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-333-2014·2013-12-18
Novartis Recalls Physician Sample Blood Pressure Medications Due to Chemical Contamination
Novartis is recalling physician sample bottles of several blood pressure medications due to contamination with a photocuring agent found in packaging inks.
Product
Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9489-07
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-347-2014·2013-12-18
Taro Recalls Subpotent Ciclopirox Shampoo 1% Prescription Bottles
Taro Pharmaceuticals is recalling 850 bottles of Ciclopirox Shampoo 1% because the product is subpotent. The recall is voluntary and nationwide.
Product
CICLOPIROX — CICLOPIROX (CICLOPIROX)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-341-2014·2013-12-18
Sandoz Recalls Bumetanide Tablets Due to Moisture Content Failures
Sandoz Inc. is recalling Bumetanide Tablets USP 0.5 mg because stability testing showed moisture content out of specification.
Product
BUMETANIDE — BUMETANIDE (BUMETANIDE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-220-2014·2013-12-11
FDA Recalls Compounded Methylprednisolone Vials Linked to Skin Abscesses
Main Street Family Pharmacy is recalling compounded methylprednisolone vials after seven reports of skin abscesses.
Product
Methylprednisolone 80mg/ml (PF) 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-210-2014·2013-12-11
Main Street Compounding Pharmacy Recalls Methylprednisolone Due to Skin Abscess Reports
Main Street Compounding Pharmacy is recalling methylprednisolone vials after seven reports of skin abscesses potentially linked to the product.
Product
Methylprednisolone 100mg/ml, 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-136-2014·2013-12-11
Main Street Compounding Pharmacy Recalls HCG 340 iu Prefilled Syringes
Main Street Family Pharmacy, LLC is recalling HCG 340 iu prefilled syringes due to adverse reactions reported for a different compounded product.
Product
HCG 340 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-095-2014·2013-12-11
Main Street Compounding Pharmacy Recalls Estradiol Pellets Due to Adverse Reactions
Main Street Family Pharmacy, LLC is recalling 543 units of Estradiol Pellets 6mg after receiving reports of skin abscesses.
Product
Estradiol Pellets 6mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Category
Drug
Distribution
Distributed nationwide

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