DrugApr 16, 2014
Terra-Medica Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral Homeopathic Medicine, OTC Only recall — FDA D-1194-2014
Penicillin Cross Contamination
Class IIFDA: TerminatedTerra-Medica Inc.
10,690drug recall records
953FDA Class I records
8firms with 5+ records
Aidapak Services, LLC537 records
Database records
Records — page 355
10,690 detailed records are currently available in this category.
DrugApr 16, 2014
Zions RX Formulations Services LLC dba RX Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and recall — FDA D-1217-2014
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Class IIFDA: TerminatedZions RX Formulations Services LLC dba RX Formuations…
DrugApr 9, 2014
Lupin Pharmaceuticals Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL recall — FDA D-1187-2014
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugApr 9, 2014
Lupin Pharmaceuticals Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL recall — FDA D-1186-2014
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugApr 9, 2014
Teva Pharmaceuticals USA Duloxetine Delayed-Release Capsules, USP, 60 mg recall — FDA D-1184-2014
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend…
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugApr 9, 2014
Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles recall — FDA D-1185-2014
Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
Class IIIFDA: TerminatedViiv Healthcare Company
DrugApr 9, 2014
Teva Pharmaceuticals USA Duloxetine Delayed-Release Capsules, USP, 20 mg recall — FDA D-1182-2014
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend…
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugApr 9, 2014
Teva Pharmaceuticals USA Duloxetine Delayed-Release Capsules, USP, 30 mg recall — FDA D-1183-2014
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend…
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugApr 9, 2014
Teva Pharmaceuticals USA QVAR recall — FDA D-1190-2014
Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
Class IIIFDA: TerminatedTeva Pharmaceuticals USA
DrugApr 2, 2014
Hill Dermaceuticals SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil recall — FDA D-1179-2014
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class IIIFDA: TerminatedHill Dermaceuticals, Inc.
DrugApr 2, 2014
Hill Dermaceuticals Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 recall — FDA D-1175-2014
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class IIIFDA: TerminatedHill Dermaceuticals, Inc.
DrugApr 2, 2014
Hill Dermaceuticals SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml recall — FDA D-1181-2014
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class IIIFDA: TerminatedHill Dermaceuticals, Inc.
DrugApr 2, 2014
DERMOTIC ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml recall — FDA D-1178-2014
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class IIIFDA: TerminatedHill Dermaceuticals, Inc.
DrugApr 2, 2014
Hill Dermaceuticals Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 recall — FDA D-1174-2014
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class IIIFDA: TerminatedHill Dermaceuticals, Inc.
DrugApr 2, 2014
Hill Dermaceuticals DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle recall — FDA D-1173-2014
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class IIIFDA: TerminatedHill Dermaceuticals, Inc.
DrugApr 2, 2014
DERMA-SMOOTHE/FS ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical recall — FDA D-1176-2014
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class IIIFDA: TerminatedHill Dermaceuticals, Inc.
DrugApr 2, 2014
Hill Dermaceuticals SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil recall — FDA D-1180-2014
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class IIIFDA: TerminatedHill Dermaceuticals, Inc.
DrugApr 2, 2014
DERMA-SMOOTHE/FS ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% recall — FDA D-1177-2014
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class IIIFDA: TerminatedHill Dermaceuticals, Inc.
DrugMar 26, 2014
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr) recall — FDA D-1172-2014
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch…
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugMar 26, 2014
Fabscout Entertainment Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 recall — FDA D-1170-2014
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical…
Class IFDA: TerminatedFabscout Entertainment, Inc.
DrugMar 26, 2014
DEXTROSE 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers recall — FDA D-1162-2014
Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers,…
Class IFDA: TerminatedBaxter Healthcare Corp.
DrugMar 26, 2014
McKesson Packaging Services Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg recall — FDA D-1167-2014
Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.
Class IIIFDA: TerminatedMcKesson Packaging Services
DrugMar 26, 2014
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr) recall — FDA D-1171-2014
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch…
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
DrugMar 26, 2014
Clinimix 5/15 sulfite-free recall — FDA D-1160-2014
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Class IFDA: TerminatedBaxter Healthcare Corp.
How to use this drug recall index
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.