Class III · Low risk
Duloxetine Delayed-release Capsules
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Mental Health Medication Recalls
Recalls of antidepressants, anti-anxiety and related psychiatric medications.
224 recalls in this category, newest first.
Class II · Moderate risk
Xanax (alprazolam)
Subpotent Drug
Class III · Low risk
buPROPion Hydrochloride Extended-¿release Tablets USP
Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
Class II · Moderate risk
CONTRAVE (naltrexone HCl and bupropion HCl)
Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.
Class II · Moderate risk
Fluoxetine Capsules USP
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Class II · Moderate risk
Fluoxetine Capsules USP
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Class II · Moderate risk
Alprazolam tablets
Subpotent Drug
Class III · Low risk
Fluoxetine Capsules USP
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
Class II · Moderate risk
Venlafaxine HCl active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Sertraline HCl active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Quetiapine Fumarate active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Fluoxetine Hydrochloride active pharmaceutical ingredient…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Duloxetine HCl active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Citalopram Hydrobromide active pharmaceutical ingredient packaged…
Penicillin Cross Contamination: All lots of all products repackaged between 01/05/12 through 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Bupropion HCI active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications; 12 month stability time point
Class II · Moderate risk
Alprazolam Tablets
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Class II · Moderate risk
Alprazolam Tablets
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Class III · Low risk
buPROPion HCl Extended-Release Tablets
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
Class III · Low risk
APLENZIN¿ (bupropion hydrobromide)
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
APLENZIN¿ (bupropion hydrobromide)
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
APLENZIN¿ (bupropion hydrobromide)
Labeling: Incorrect or Missing Package Insert
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.