DrugDec 20, 2017
Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. recall — FDA D-0109-2018
Microbial Contamination of Non-Sterile Products
Class IIFDA: TerminatedSun Pharmaceutical Industries, Inc.
10,690drug recall records
953FDA Class I records
8firms with 5+ records
Aidapak Services, LLC537 records
Database records
Records — page 231
10,690 detailed records are currently available in this category.
DrugDec 20, 2017
Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL recall — FDA D-0108-2018
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Class IIIFDA: TerminatedTeva Pharmaceuticals USA
DrugDec 13, 2017
Gadget Island grande X 5800 capsule recall — FDA D-0106-2018
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Class IFDA: TerminatedGadget Island, Inc.
DrugDec 13, 2017
International Laboratories Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle recall — FDA D-0102-2018
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
Class IFDA: TerminatedInternational Laboratories, Inc.
DrugDec 6, 2017
Levetiracetam Oral Solution, USP, 100 mg/mL recall — FDA D-0099-2018
Presence of foreign substance (screw)
Class IIFDA: TerminatedHetero Labs, Ltd. - Unit III
DrugDec 6, 2017
Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count recall — FDA D-0101-2018
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Class IIFDA: TerminatedZydus Pharmaceuticals USA Inc.
DrugDec 6, 2017
EAI-JR286 Vertra Elemental Resistance recall — FDA D-0100-2018
CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
Class IIFDA: TerminatedEAI-JR286 Inc.
DrugNov 29, 2017
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01) recall — FDA D-0093-2018
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Class IIIFDA: TerminatedWest-Ward Pharmaceuticals Corp.
DrugNov 29, 2017
Ridge Properties Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel recall — FDA D-0089-2018
GMP Deviations: inadequate manufacturing control processes
Class IIFDA: TerminatedRidge Properties, LLC
DrugNov 29, 2017
Ridge Properties Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine recall — FDA D-0086-2018
GMP Deviations: inadequate manufacturing control processes
Class IIFDA: TerminatedRidge Properties, LLC
DrugNov 29, 2017
Ridge Properties Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel recall — FDA D-0087-2018
GMP Deviations: inadequate manufacturing control processes
Class IIFDA: TerminatedRidge Properties, LLC
DrugNov 29, 2017
Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle recall — FDA D-0092-2018
Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium…
Class IIFDA: TerminatedLupin Limited
DrugNov 29, 2017
Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials recall — FDA D-0094-2018
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Class IIIFDA: TerminatedWest-Ward Pharmaceuticals Corp.
DrugNov 29, 2017
Ridge Properties Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine recall — FDA D-0088-2018
GMP Deviations: inadequate manufacturing control processes
Class IIFDA: TerminatedRidge Properties, LLC
DrugNov 22, 2017
Fagron Estriol, For Prescription Compounding recall — FDA D-0079-2018
cGMP Deviations: lack of quality assurance at the API manufacturer.
Class IIFDA: TerminatedFagron, Inc.
DrugNov 22, 2017
Combigan recall — FDA D-0077-2018
Failed Impurities/Degradation Specifications.
Class IIIFDA: TerminatedAllergan Sales, LLC
DrugNov 22, 2017
Llorens Pharmaceutical Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg recall — FDA D-0081-2018
Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or Superpotent tablets.
Class IIFDA: TerminatedLlorens Pharmaceutical Corp.
DrugNov 15, 2017
Dr. Reddy's Laboratories Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol recall — FDA D-0072-2018
Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle
Class IIIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugNov 15, 2017
Ace Surgical Supply Co Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials recall — FDA D-0071-2018
Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag
Class IIFDA: TerminatedAce Surgical Supply Co., Inc.
DrugNov 15, 2017
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP recall — FDA D-0070-2018
Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and…
Class IIFDA: TerminatedPurdue Pharma, LP
DrugNov 8, 2017
AVKARE Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per recall — FDA D-0055-2018
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Class IIFDA: TerminatedAVKARE Inc.
DrugNov 8, 2017
Sanofi-Aventis U.S Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial recall — FDA D-0056-2018
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
Class IIIFDA: TerminatedSanofi-Aventis U.S. LLC
DrugNov 8, 2017
SCA Pharmaceuticals fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl recall — FDA D-0063-2018
Lack Of Assurance Of Sterility.
Class IIFDA: TerminatedSCA Pharmaceuticals, LLC
DrugNov 8, 2017
Precision Dose Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups recall — FDA D-0057-2018
Subpotent Drug: low out of specification results.
Class IIIFDA: TerminatedPrecision Dose Inc.
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.