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

13151–13175 of 18042

ModerateFDA (Drugs)·D-0015-2016·2015-10-21
Ferring Recalls Bravelle 75 IU Vials Due to Subpotent Drug
Ferring Pharmaceuticals is recalling 32,341 vials of Bravelle 75 IU because the drug was found to be subpotent. The recall is voluntary and nationwide.
Product
Bravelle 75 IU (urofollitropin for injection, purified) For Subcutaneous or Intramuscular Injection Only, 1 Carton (contains 5 single dose vials of Bravelle, 5 single dose vials of 0.9% Sodium Chloride Inj., USP, 2 mL, and 5 Q-Cap Vial Adaptors) , Rx Only, Manufactured for…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0022-2016·2015-10-21
Loratadine Tablets Recalled for Out-of-Specification Assay Results
Ohm Laboratories is recalling CareOne Loratadine tablets because they failed potency testing. Consumers should stop using the affected products.
Product
CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0035-2016·2015-10-21
TopCare Loratadine Tablets Recalled for Out-of-Specification Assay Results
Ohm Laboratories is recalling TopCare Loratadine tablets because they failed potency testing. Consumers should stop using the affected products.
Product
TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0023-2016·2015-10-21
CVS Loratadine Tablets Recalled for Out-of-Specification Assay Results
CVS Pharmacy loratadine tablets are being recalled because they failed potency testing. Consumers should stop using the product and return it to the pharmacy.
Product
CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count tablets per box, Item 876239, UPC 0 50428 61152 4, and b) 30-count tablets per box, Item 367404, UPC 0 50428 11367 7, Distributed by: CVS Pharmacy, Inc.…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0026-2016·2015-10-21
Fred's Loratadine Tablets Recalled for Out-of-Specification Assay Results
Ohm Laboratories is recalling Fred's Loratadine Orally Disintegrating Tablets due to an out-of-specification assay result. The FDA classifies this as a Class III recall.
Product
Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New Getwell Road, Memphis, TN 38118, UPC 0 8457912198 4.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0037-2016·2015-10-21
Sunmark Loratadine Tablets Recalled for Out-of-Specification Assay Results
Ohm Laboratories is recalling Sunmark loratadine tablets because they failed potency testing. Consumers should stop using the affected products.
Product
Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0016-2016·2015-10-21
Tribute Pharmaceuticals Recalls Fenofibric Acid Tablets Due to Benzophenone Contamination
Tribute Pharmaceuticals is recalling specific lots of Fenofibric Acid Tablets because they may contain trace amounts of benzophenone from label varnish.
Product
Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fenofibric acid) Tablets, NDC 13310-101-07, UPC 3 13310-101-07 8, Manufactured for: AR SCIENTIFIC, INC., Philadelphia, PA 19124 USA; by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA 19124 USA; b)…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0020-2016·2015-10-21
Rite Aid Loratadine Tablets Recalled for Out-of-Specification Assay
Ohm Laboratories is recalling Rite Aid Pharmacy loratadine orally disintegrating tablets because they failed an assay test, resulting in a superpotent drug classification.
Product
Rite Aid Pharmacy loratadine orally disintegrating tablets USP, 10 mg, packaged in a) 30-count tablets per box, Item 352712, UPC 0 11822 52712 5; b) 60-count tablets per box, Item 353672, UPC 0 11822 53672 1. Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0017-2016·2015-10-21
Tribute Pharmaceuticals Recalls Fenofibric Acid Tablets Due to Benzophenone Contamination
Tribute Pharmaceuticals is recalling 140,607 bottles of Fenofibric Acid Tablets 105 mg because they may contain trace amounts of benzophenone from label varnish.
Product
Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric acid) Tablets, 30-count bottles, NDC 13310-102-07, UPC 3 13310-102-07 5; b) FIBRICOR (fenofibric acid) Tablets, 90-count bottles, NDC 13310-102-90, UPC 3 13310-102-90 7; Manufactured for: AR SCIENTIFIC…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0031-2016·2015-10-21
Major Loratadine Tablets Recalled for Out-of-Specification Assay Results
Ohm Laboratories is recalling Major loratadine orally disintegrating tablets due to out-of-specification assay results. The recall covers 29,360 boxes distributed nationwide.
Product
Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0021-2016·2015-10-21
Ohm Laboratories Recalls Loratadine Tablets Due to Assay Failure
Ohm Laboratories is recalling specific batches of loratadine tablets because they failed potency testing. Consumers should stop using the affected products.
Product
Health Best Choice Care, Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, MO 64111; UPC 0 7003861209 4
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0038-2016·2015-10-21
Ohm Laboratories Recalls Loratadine Tablets Due to Potency Issues
Ohm Laboratories is recalling Wal-itin Loratadine Orally Disintegrating Tablets because they failed potency testing. The FDA classified this as a Class III recall.
Product
Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-coiunt tablets per box, (NDC 0363-0527-69, ITEM 367492,UPC 3 1191717021 3); and b) 30-count tablets per box, (NDC 0363-0527-31, ITEM 254166, UPC 3 191715562 ) Distributed by Walgreen Co., 200 Wilmot…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0034-2016·2015-10-21
Safeway Care Loratadine Tablets Recalled for Out-of-Specification Assay
Ohm Laboratories is recalling Safeway Care Loratadine Orally Disintegrating Tablets because they failed potency testing. Consumers should stop using the affected products.
Product
Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 21130-527-69, UPC 3 2113076240 9); b) 30-count tablets per box (NDC 21130-527-31, UPC 3 2113076252 2) Distributed by Safeway Inc. PO BOX 99, Pleasanton, CA 94566
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0007-2016·2015-10-14
Merck Recalls Vytorin Tablets Due to Foreign Tablet Presence
Merck Sharp & Dohme is recalling specific bottles of Vytorin 10 mg/20 mg tablets because they contain 10 mg/40 mg tablets. The recall affects distribution in Kentucky, Mississippi, and Ohio.
Product
Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg ezetimibe and 20 mg simvastatin, Rx Only, 1000 count Bottle, Manuf. For Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, NDC 66582-0312-82.
Category
Drug
Distribution
3 states
SevereFDA (Drugs)·D-0006-2016·2015-10-14
Sermorelin Injection Recalled Due to Sterility Assurance Concerns
DCA Pharmacy is recalling 129 vials of Sermorelin 6mg/6mL Lyophilized Powder because an FDA inspection found it was not compounded in an appropriate area, potentially compromising sterility.
Product
Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527
Category
Drug
Distribution
3 states
ModerateFDA (Drugs)·D-0008-2016·2015-10-14
Daytrana Methylphenidate Patches Recalled for Defective Delivery System
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) 30 mg patches due to a defective delivery system that failed mechanical peel force specifications.
Product
DAYTRANA — DAYTRANA (METHYLPHENIDATE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1830-2015·2015-10-07
Hartley Medical Recalls Non-Sterile Prolotherapy with Phenol Vials
Hartley Medical Center Pharmacy is recalling 10 vials of Prolotherapy with Phenol due to non-sterility concerns. The product was distributed in California and Nevada.
Product
Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 100 mL vial, Rx Only, Hartley Medical, (888) 671-2888
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-1829-2015·2015-10-07
Hartley Medical Recalls Prolotherapy with Phenol Vials Due to Non-Sterility
Hartley Medical Center Pharmacy is recalling 14 vials of Prolotherapy with Phenol due to non-sterility concerns. The product was distributed in California and Nevada.
Product
Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl 0.625%, Phenol 1%, QS SWI), 5 mL vial, Rx Only, Hartley Medical, (888) 671-2888
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-1833-2015·2015-10-07
Medistat RX Recalls Sterile Products Due to Sterility Assurance Concerns
Medistat RX L.L.C. is recalling all sterile products, including various injectable medications, due to a lack of assurance of sterility.
Product
All Products Intended to be Sterile, mediStat Pharmacy, 110 East Azalea Ave., Foley, AL 36535, 844*737*2550. An Incomplete List of Recalled Products Includes 1) All Cyanacobalamin Products, 2) All Magnesium Chloride Products, 3) All Lipostat (MIC B12) Products, 4) All Trimix…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1832-2015·2015-10-07
Eagle Pharmacy Recalls Subpotent Lipo B Sterile Injection Vials
Eagle Pharmacy is recalling 104 vials of Lipo B Sterile Injection due to trace amounts of methylcobalamin. The product was distributed in Alabama and Tennessee.
Product
LIPO B STERILE INJECTION 10 mL ( Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine Hydrochloride 5 mg, Methylcobalamin 0.1mg, Benzyl Alcohol, Sterile Water, Sodium Hydroxide, Hydrochloric Acid), Multidose vial, Rx Only, Compounded by Eagle Pharmacy…
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-0005-2016·2015-10-07
Guthy-Renker Recalls Subpotent Rodan & Fields Proactiv Foundation
Guthy-Renker LLC is recalling Rodan & Fields Proactiv Solution compact foundation because the salicylic acid ingredient is subpotent.
Product
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, DARK, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0001-2016·2015-10-07
Guthy-Renker Recalls Rodan & Fields Proactiv Foundation for Subpotent Salicylic Acid
Guthy-Renker LLC is recalling Rodan & Fields Proactiv Solution Compact Foundation because the salicylic acid ingredient is subpotent.
Product
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, FAIR, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0003-2016·2015-10-07
Guthy-Renker Recalls Subpotent Rodan & Fields Proactiv Foundation
Guthy-Renker LLC is recalling Rodan & Fields Proactiv Solution Compact Foundation because the salicylic acid ingredient is subpotent.
Product
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, MEDIUM, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1831-2015·2015-10-07
VistaPharm Recalls Metoclopramide Oral Solution Due to Defective Container Lids
VistaPharm is recalling 84,100 cups of Metoclopramide Oral Solution because the unit dose cup lids are not fully qualified.
Product
METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 66689-031-01.
Category
Drug
Distribution
6 states
LowFDA (Drugs)·D-0004-2016·2015-10-07
Guthy-Renker Recalls Subpotent Rodan & Fields Proactiv Foundation
Guthy-Renker LLC is recalling specific lots of Rodan & Fields Proactiv Solution Compact Foundation because the salicylic acid ingredient is subpotent.
Product
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, TAN, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250.
Category
Drug
Distribution
Distributed nationwide

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13151–13175 of 18042