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

7326–7350 of 8593

SevereFDA (Drugs)·D-388-2014·2014-01-01
GlaxoSmithKline Recalls Sumatriptan Injection Cartridges Due to Sterility Concerns
GlaxoSmithKline is recalling 9,743 cartridges of Sumatriptan Succinate Injection because some may have needles protruding through the shield, compromising sterility.
Product
Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumatriptan Autoinjector Pen, Manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 for Sandoz Inc., Princeton, NJ 08540, Made in Sing
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-373-2014·2013-12-25
Purity First B-50 Capsules Recalled for Undeclared Steroids
Healthy Life Chemistry is recalling B-50 capsules because FDA analysis found undeclared steroids, making the product an unapproved new drug.
Product
B-50 capsules, 100-count bottles, labeled in part as Healthy Life Chemistry, By Purity First, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735; 1-800-696-7017
Category
Drug
Distribution
3 states
CriticalFDA (Drugs)·D-377-2014·2013-12-25
Dietary Supplement Recalled for Undeclared Sildenafil and Lack of FDA Approval
Fabscout Entertainment is recalling 72HP Maximum Potency Male Sexual Enhancement because it contains undeclared sildenafil and was marketed without FDA approval.
Product
72HP MAXIMUM POTENCY MALE SEXUAL ENHANCEMENT, Dietary Supplement, supplied in 1 capsule per blister pack, Distributed by: 72HP, Inc. Weston, FL
Category
Drug
Distribution
3 states
CriticalFDA (Drugs)·D-375-2014·2013-12-25
Altaire Recalls Carboxymethylcellulose Sodium Eye Drops Due to Non-Sterility
Altaire Pharmaceuticals is recalling specific lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution because the preservative may not be effective through expiry, posing a non-sterility risk.
Product
Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottle, sold under the following labels: (a) CVS pharmacy brand LUBRICANT EYE DROPS FOR MILD TO MODERATE DRY EYE, Distributed by CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 053357 7 and UPC 0 50428
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-376-2014·2013-12-25
Evil Root 1200 mg Recalled for Undeclared Sildenafil
Fabscout Entertainment, Inc. is recalling Evil Root 1200 mg capsules because the product contains undeclared sildenafil and was marketed without FDA approval.
Product
Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang Health Medicine Co.,Ltd. Address: No. 98, Min zu Road, Lhasa
Category
Drug
Distribution
3 states
CriticalFDA (Drugs)·D-371-2014·2013-12-25
Quick Thin capsules recalled for containing unapproved drugs
Bethel Nutritional Consulting is recalling Quick Thin capsules because FDA analysis detected unapproved drugs sibutramine and phenolphthalein.
Product
Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powder, alfalfa, mulberry leaf, guarana, spirulina) capsules, 400 mg, 30-count bottle, Distributed by: Bethel, Inc., Tel: (212) 568-5330.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-370-2014·2013-12-25
Zi Xiu Tang Ultimate Formula Recalled for Undeclared Sibutramine
Zi Xiu Tang Success, LLC is recalling Ultimate Formula capsules because they contain undeclared sibutramine, an ingredient removed from the market for safety reasons.
Product
Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 7 9357304140 1
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-381-2014·2013-12-25
Hospira Recalls Bupivacaine Hydrochloride Injection Due to Particulate Matter
Hospira Inc. is recalling 119,600 vials of Bupivacaine Hydrochloride Injection due to the presence of visible particulate matter.
Product
BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-380-2014·2013-12-25
Hospira Recalls Bupivacaine Hydrochloride Injection Due to Particulate Matter
Hospira Inc. is recalling 118,100 vials of 0.25% Bupivacaine Hydrochloride Injection due to the presence of visible particulate matter.
Product
BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-369-2014·2013-12-25
Bee Pollen Capsules Recalled for Undeclared Sibutramine
Zi Xiu Tang Success, LLC is recalling Classic Zi Xiu Tang Bee Pollen Capsules because they contain undeclared sibutramine, an unapproved active ingredient.
Product
Classic Zi Xiu Tang, Bee Pollen Capsule, Net Wt. 250 mg x 60 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 6 937000 700019
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-378-2014·2013-12-25
PRO POWER MAX Energy Capsules Recalled for Undeclared Sildenafil and Tadalafil
Fabscout Entertainment is recalling PRO POWER MAX Natural Energy Enhancer capsules because they contain undeclared sildenafil and tadalafil and were marketed without FDA approval.
Product
PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied in 1 capsule per blister pack, Distributed by MSH Distribution LLC
Category
Drug
Distribution
3 states
SevereFDA (Drugs)·D-367-2014·2013-12-25
West-Ward Recalls Carisoprodol Tablets Due to Foreign Substance Presence
West-Ward Pharmaceutical Corp. is recalling 20,534 bottles of Carisoprodol Tablets, USP 350 mg, because heavy metals and inactive components were visually observed during routine stability testing.
Product
Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-368-2014·2013-12-25
Baxter Recalls Travasol Amino Acid Injection Due to Sterility Concerns
Baxter Healthcare is recalling 14,622 bags of Travasol Amino Acid Injection because leaking containers prevent assurance of sterility.
Product
TRAVASOL — TRAVASOL (LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, TYROSINE, SERINE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-372-2014·2013-12-25
Bethel Advance capsules recalled for unapproved drug ingredients
Bethel Nutritional Consulting is recalling Bethel Advance capsules because FDA analysis detected unapproved drug ingredients, including phenolphthalein and sibutramine.
Product
Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spirulina, starch, kola nut) capsules, 400 mg, 30-count bottles, Distributed by: Bethel, Inc., Tel: (212) 568-5330, UPC 1 60126 41750 9.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-374-2014·2013-12-25
Purity First Recalls Multi-Mineral Capsules for Undeclared Steroids
Healthy Life Chemistry is recalling multi-mineral capsules because they contain undeclared steroid-like substances, making them unapproved new drugs.
Product
Multi-Mineral capsules, 200-count bottles, labeled in part as Healthy Life Chemistry, By Purity First, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735; 1-800-696-7017
Category
Drug
Distribution
3 states
CriticalFDA (Drugs)·D-345-2014·2013-12-18
Volcano Male Enhancement Capsules Recalled for Undeclared Pharmaceutical Ingredients
Myson Corporation is recalling Volcano Male Enhancement capsules because they contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.
Product
Volcano Male Enhancement 1500mg, 1-count capsule packaged in a black round plastic pop top container, (Proprietary Formula, Pueraria lobata, Cinnamon Bark, Cuscuta, Gui, Licorice, Altractylodes, Dang Condonopsis, Dismutase, Cornus, Rubus, Deng Sen Extract, Panax Ginseng, Cordycep
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-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-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
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 # 0078
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-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
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-315-2014·2013-12-11
Main Street Compounding Pharmacy Recalls Triamcinolone Diacetate Due to Adverse Reactions
Main Street Family Pharmacy is recalling Triamcinolone Diacetate 40mg 10ml vials after receiving reports of skin abscesses linked to a related compounded product.
Product
Triamcinolone Diacetate 40mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Category
Drug
Distribution
Distributed nationwide

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