Class III · Low risk Terminated
Lisinopril Tablets USP 20 mg
Reason Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
FDA Drug Recalls
17,898 recalls, newest first
Class III · Low risk Terminated
Buspirone Hydrochloride Tabs USP 10 mg
Reason Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Class II · Moderate risk Terminated
Extended Phenytoin Sodium Capsules
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Mycophenolate Mofetil for Oral Suspension
Reason Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Class I · High risk Terminated
Phenytoin Oral Suspension
Reason Failed Content Uniformity Specifications
Class III · Low risk Terminated
Esomeprazole Magnesium Delayed-Release Capsules
Reason Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
Class II · Moderate risk Ongoing
Ranolazine Extended-Release Tablets 500mg
Reason Failed Dissolution Specifications: Out of specification for dissolution.
Class I · High risk Ongoing
Kuka Flex Forte caplets
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class I · High risk Ongoing
Reumo Flex caplets
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class I · High risk Ongoing
Artri King Reforzado con Origa y Omega 3 tablets
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class II · Moderate risk Terminated
Tiglutik
Reason Failed Viscosity Specifications: Out-of-specification test results for viscosity
Class II · Moderate risk Ongoing
Equate Hand Sanitizer
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Class II · Moderate risk Ongoing
DOP Instant Hand Sanitizer
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Class II · Moderate risk Ongoing
DOP Instant Hand Sanitizer
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Class II · Moderate risk Ongoing
Deferasirox Tablets for Oral Suspension
Reason Failed Dissolution Specifications
Class III · Low risk Ongoing
Oxaydo
Reason Sub-potent Drug: Lower potency than labeled.
Class III · Low risk Terminated
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Liothyronine Sodium Tablets
Reason Failed Impurities/Degradation Specifications.
Class II · Moderate risk Terminated
Liothyronine Sodium Tablets
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Opium Tincture
Reason Subpotent Drug
Class II · Moderate risk Completed
Oxybutynin Chloride Extended-Release Tablet USP
Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class II · Moderate risk Completed
Oxybutynin Chloride Extended-Release Tablet USP
Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class II · Moderate risk Completed
Oxybutynin Chloride Extended-Release Tablet USP
Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class II · Moderate risk Terminated
Strong Iodine Solution U.S.P.
Reason CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Class I · High risk Ongoing
Elcys
Reason Presence of Particulate Matter: Silicone