DrugNov 8, 2017
SCA Pharmaceuticals fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% recall — FDA D-0062-2018
Lack Of Assurance Of Sterility.
Class IIFDA: TerminatedSCA Pharmaceuticals, LLC
10,690drug recall records
953FDA Class I records
8firms with 5+ records
Aidapak Services, LLC537 records
Database records
Records — page 232
10,690 detailed records are currently available in this category.
DrugNov 8, 2017
SCA Pharmaceuticals HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 recall — FDA D-0060-2018
Lack Of Assurance Of Sterility.
Class IIFDA: TerminatedSCA Pharmaceuticals, LLC
DrugNov 8, 2017
SCA Pharmaceuticals morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 recall — FDA D-0064-2018
Lack Of Assurance Of Sterility.
Class IIFDA: TerminatedSCA Pharmaceuticals, LLC
DrugNov 8, 2017
SCA Pharmaceuticals PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill recall — FDA D-0066-2018
Lack Of Assurance Of Sterility.
Class IIFDA: TerminatedSCA Pharmaceuticals, LLC
DrugNov 8, 2017
Teva Pharmaceuticals USA Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg recall — FDA D-0069-2018
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugNov 8, 2017
SCA Pharmaceuticals HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium recall — FDA D-0061-2018
Lack Of Assurance Of Sterility.
Class IIFDA: TerminatedSCA Pharmaceuticals, LLC
DrugNov 8, 2017
SCA Pharmaceuticals ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe recall — FDA D-0068-2018
Lack Of Assurance Of Sterility.
Class IIFDA: TerminatedSCA Pharmaceuticals, LLC
DrugNov 8, 2017
Kiriko, LLC A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle recall — FDA D-0058-2018
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for…
Class IIFDA: TerminatedKiriko, LLC.
DrugNov 1, 2017
Fluocinonide Gel USP, 0.05%, 15 g tube recall — FDA D-0146-2018
Cross contamination with other products: traces of Dapsone were found in the finished product.
Class IIIFDA: TerminatedTaro Pharmaceuticals U.S.A., Inc.
DrugNov 1, 2017
Vitility MAN OF STEEL capsules, 3000mgs/grain, 1-count packets recall — FDA D-0032-2018
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an…
Class IFDA: TerminatedVitility
DrugNov 1, 2017
Wockhardt Usa Enalapril Maleate tablets, USP, 5mg, 1000-count bottles recall — FDA D-0051-2018
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Class IIIFDA: TerminatedWockhardt Usa Inc.
DrugNov 1, 2017
Becton Dickinson & Company ChloraPrep OneStep (Clear) recall — FDA D-0029-2018
Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)
Class IIFDA: TerminatedBecton Dickinson & Company
DrugNov 1, 2017
Intralipid 20%, A 20% I.V recall — FDA D-0030-2018
Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to…
Class IFDA: TerminatedBaxter Healthcare Corporation
DrugNov 1, 2017
Vi-Jon Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) recall — FDA D-0073-2018
Failed Stability Specifications
Class IIIFDA: TerminatedVi-Jon, Inc.
DrugNov 1, 2017
AbbVie AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone recall — FDA D-0033-2018
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Class IIIFDA: TerminatedAbbVie Inc.
DrugNov 1, 2017
Aidarex Pharmaceuticals ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles recall — FDA D-0053-2018
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Class IIIFDA: TerminatedAidarex Pharmaceuticals LLC
DrugOct 25, 2017
Bisoprolol Fumarate tablets, 5 mg, 30-count bottles recall — FDA D-0010-2018
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Class IIFDA: TerminatedUnichem Pharmaceuticals Usa Inc.
DrugOct 25, 2017
RXQ Compounding methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ recall — FDA D-0012-2018
Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
Class IIFDA: TerminatedRXQ Compounding LLC
DrugOct 25, 2017
The Harvard Drug Group Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per recall — FDA D-0013-2018
Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
Class IIFDA: TerminatedThe Harvard Drug Group
DrugOct 18, 2017
Boehringer Ingelheim Pharmaceuticals Mobic (meloxicam) tablets, 15 mg, package in 100-count recall — FDA D-0007-2018
Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
Class IIIFDA: TerminatedBoehringer Ingelheim Pharmaceuticals, Inc.
DrugOct 18, 2017
United Pharmacy Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial) recall — FDA D-0008-2018
CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
Class IIFDA: TerminatedUnited Pharmacy
DrugOct 18, 2017
Famotidine tablets, 10 mg recall — FDA D-0009-2018
Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for…
Class IIIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugOct 11, 2017
Inopak Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. recall — FDA D-0002-2018
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
Class IIFDA: TerminatedInopak Ltd
DrugOct 11, 2017
Inopak Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Disc Pump recall — FDA D-0003-2018
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Class IIFDA: TerminatedInopak Ltd
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.