An automatically updated view of FDA recall and enforcement records for the behavioral-health medications we track. Data is pulled directly from openFDA.
85 ongoing recalls across the 30 medications we monitor. This feed refreshes automatically from the FDA.
| Initiated | Medication | Reason | Class | Status |
|---|---|---|---|---|
| June 26, 2026 | Dextroamphetamine Sulfate | Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules. | Class II | Ongoing |
| June 26, 2026 | Divalproex Sodium | Presence of Foreign Tablets/Capsules | Class II | Ongoing |
| June 4, 2026 | Duloxetine Hydrochloride | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Ongoing |
| June 4, 2026 | Duloxetine Hydrochloride | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Ongoing |
| June 2, 2026 | Hydroxyzine Hydrochloride | Presence of foreign substance | Class III | Ongoing |
| May 27, 2026 | Aripiprazole | Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg. | Class II | Ongoing |
| April 30, 2026 | Atomoxetine Hydrochloride | Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule. | Class II | Ongoing |
| April 21, 2026 | Duloxetine Hydrochloride | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit | Class II | Ongoing |
| April 13, 2026 | Buspirone Hydrochloride | Subpotent drug | Class III | Ongoing |
| March 19, 2026 | Clonidine Hydrochloride | CGMP Deviations: use of an unapproved raw material | Class II | Ongoing |
| March 19, 2026 | Clonidine Hydrochloride | CGMP Deviations: use of an unapproved raw material | Class II | Ongoing |
| March 19, 2026 | Clonidine Hydrochloride | CGMP Deviations: use of an unapproved raw material | Class II | Ongoing |
| January 26, 2026 | Trazodone Hydrochloride | Presence of Foreign Tablets/Capsules | Class II | Ongoing |
| December 19, 2025 | Trazodone Hydrochloride | Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface. | Class III | Ongoing |
| November 24, 2025 | Duloxetine Hydrochloride | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit | Class II | Ongoing |
| November 24, 2025 | Duloxetine Hydrochloride | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit | Class II | Ongoing |
| November 5, 2025 | Sertraline Hydrochloride | Defective container - seal not adhering to bottles | Class II | Ongoing |
| October 28, 2025 | Lisdexamfetamine Dimesylate | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate ca | Class II | Ongoing |
| October 28, 2025 | Lisdexamfetamine Dimesylate | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate ca | Class II | Ongoing |
| October 28, 2025 | Lisdexamfetamine Dimesylate | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate ca | Class II | Ongoing |
| October 28, 2025 | Lisdexamfetamine Dimesylate | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate ca | Class II | Ongoing |
| October 28, 2025 | Lisdexamfetamine Dimesylate | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate ca | Class II | Ongoing |
| October 28, 2025 | Lisdexamfetamine Dimesylate | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate ca | Class II | Ongoing |
| October 28, 2025 | Lisdexamfetamine Dimesylate | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate ca | Class II | Ongoing |
| October 22, 2025 | Clomipramine Hydrochloride | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. | Class II | Ongoing |
| October 22, 2025 | Clomipramine Hydrochloride | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. | Class II | Ongoing |
| October 22, 2025 | Clomipramine Hydrochloride | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. | Class II | Ongoing |
| October 9, 2025 | Duloxetine Hydrochloride | CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. | Class II | Ongoing |
| September 15, 2025 | Bupropion Hydrochloride | Failed Tablet/Capsule Specifications | Class II | Ongoing |
| August 28, 2025 | Aripiprazole | Superpotent drug | Class II | Ongoing |
| August 28, 2025 | Dextroamphetamine Sulfate | Failed Impurities/Degradation Specifications: | Class III | Ongoing |
| August 28, 2025 | Dextroamphetamine Sulfate | Failed Impurities/Degradation Specifications: | Class III | Ongoing |
| August 28, 2025 | Dextroamphetamine Sulfate | Failed Impurities/Degradation Specifications: | Class III | Ongoing |
| August 28, 2025 | Dextroamphetamine Sulfate | Failed Impurities/Degradation Specifications: | Class III | Ongoing |
| August 28, 2025 | Dextroamphetamine Sulfate | Failed Impurities/Degradation Specifications: | Class III | Ongoing |
| August 19, 2025 | Dextroamphetamine Sulfate | Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained on | Class II | Completed |
| August 11, 2025 | Lisdexamfetamine Dimesylate | Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg. | Class II | Terminated |
| August 8, 2025 | Duloxetine Hydrochloride | CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. | Class II | Ongoing |
| July 25, 2025 | Duloxetine Hydrochloride | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Ongoing |
| July 15, 2025 | Duloxetine Hydrochloride | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit | Class II | Ongoing |
| June 30, 2025 | Duloxetine Hydrochloride | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Ongoing |
| June 27, 2025 | Clomipramine Hydrochloride | Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry. | Class II | Terminated |
| June 16, 2025 | Lisdexamfetamine Dimesylate | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH). | Class II | Ongoing |
| May 27, 2025 | Fluoxetine Hydrochloride | CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. | Class II | Completed |
| May 27, 2025 | Fluoxetine Hydrochloride | CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. | Class II | Completed |
| April 14, 2025 | Duloxetine Hydrochloride | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Class II | Ongoing |
| April 14, 2025 | Duloxetine Hydrochloride | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Class II | Ongoing |
| April 10, 2025 | Clomipramine Hydrochloride | Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study. | Class II | Terminated |
| March 26, 2025 | Duloxetine Hydrochloride | CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit. | Class II | Ongoing |
| March 21, 2025 | Venlafaxine Hydrochloride | Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet. | Class II | Completed |
| February 28, 2025 | Duloxetine Hydrochloride | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Ongoing |
| February 28, 2025 | Duloxetine Hydrochloride | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Ongoing |
| February 28, 2025 | Duloxetine Hydrochloride | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Ongoing |
| January 29, 2025 | Atomoxetine Hydrochloride | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Ongoing |
| January 29, 2025 | Atomoxetine Hydrochloride | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Ongoing |
| January 29, 2025 | Atomoxetine Hydrochloride | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Ongoing |
| January 29, 2025 | Atomoxetine Hydrochloride | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Ongoing |
| January 29, 2025 | Atomoxetine Hydrochloride | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Ongoing |
| January 29, 2025 | Atomoxetine Hydrochloride | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Ongoing |
| January 29, 2025 | Atomoxetine Hydrochloride | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Ongoing |
| January 29, 2025 | Atomoxetine Hydrochloride | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Ongoing |
| January 29, 2025 | Atomoxetine Hydrochloride | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Ongoing |
| January 29, 2025 | Atomoxetine Hydrochloride | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Ongoing |
| January 29, 2025 | Atomoxetine Hydrochloride | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Ongoing |
| January 29, 2025 | Atomoxetine Hydrochloride | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Ongoing |
| January 29, 2025 | Atomoxetine Hydrochloride | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Ongoing |
| January 29, 2025 | Atomoxetine Hydrochloride | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Ongoing |
| January 16, 2025 | Venlafaxine Hydrochloride | Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet | Class III | Completed |
| December 6, 2024 | Duloxetine Hydrochloride | CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Ongoing |
| December 6, 2024 | Duloxetine Hydrochloride | CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Ongoing |
| November 25, 2024 | Olanzapine | Failed Impurities/Degradation Specifications | Class II | Ongoing |
| October 25, 2024 | Lisdexamfetamine Dimesylate | Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity. | Class II | Terminated |
| October 10, 2024 | Duloxetine Hydrochloride | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Completed |
| June 24, 2024 | Bupropion Hydrochloride | Failed Dissolution Specifications; the product is dissolving faster than the specified limits. | Class II | Ongoing |
| June 21, 2024 | Venlafaxine Hydrochloride | Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals. | Class II | Terminated |
| June 17, 2024 | Methylphenidate Hydrochloride | Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications. | Class II | Terminated |
| May 17, 2024 | Duloxetine Hydrochloride | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Terminated |
| April 9, 2024 | Aripiprazole | Cross Contamination with Other Products | Class III | Ongoing |
| April 9, 2024 | Aripiprazole | Cross Contamination with Other Products | Class III | Ongoing |
| April 9, 2024 | Aripiprazole | Cross Contamination with Other Products | Class III | Ongoing |
| April 9, 2024 | Aripiprazole | Cross Contamination with Other Products | Class III | Ongoing |
| January 4, 2024 | Dextroamphetamine Sulfate | Labeling: Label Mix-up | Class I | Terminated |
| December 29, 2023 | Bupropion Hydrochloride | Presence of Foreign Tablets/Capsules | Class II | Ongoing |
| December 26, 2023 | Divalproex Sodium | Failed dissolution specifications | Class II | Terminated |
| December 11, 2023 | Sertraline Hydrochloride | CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product. | Class II | Ongoing |
| November 22, 2023 | Bupropion Hydrochloride | Failed Dissolution Specifications | Class III | Terminated |
| November 10, 2023 | Paroxetine Hydrochloride | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine | Class II | Terminated |
| November 10, 2023 | Paroxetine Hydrochloride | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine | Class II | Terminated |
| November 10, 2023 | Paroxetine Hydrochloride | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine | Class II | Terminated |
| November 1, 2023 | Paroxetine Hydrochloride | Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine | Class II | Ongoing |
| November 1, 2023 | Paroxetine Hydrochloride | Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine | Class II | Ongoing |
| November 1, 2023 | Paroxetine Hydrochloride | Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine | Class II | Ongoing |
| November 1, 2023 | Paroxetine Hydrochloride | Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine | Class II | Ongoing |
| October 27, 2023 | Buspirone Hydrochloride | Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots | Class III | Terminated |
| October 27, 2023 | Buspirone Hydrochloride | Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots | Class III | Terminated |
| October 4, 2023 | Bupropion Hydrochloride | Failed Dissolution Specifications | Class III | Terminated |
| July 13, 2023 | Methylphenidate Hydrochloride | Presence of Foreign Substance: Metal embedded in a tablet. | Class II | Terminated |
| May 31, 2023 | Ziprasidone Hydrochloride | Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg. | Class I | Terminated |
| May 9, 2023 | Bupropion Hydrochloride | Failed Dissolution Specifications; during stability testing | Class II | Terminated |
| March 17, 2023 | Aripiprazole | Out of specification (OOS) for Spectroscopic Identification test by IR. | Class II | Ongoing |
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Request an Appointment Call (801) 255-5131Not medical advice. This page summarizes publicly available FDA drug labeling alongside general guidance from Bridgeway Integrated Healthcare Services. It is for educational purposes only and is not a substitute for advice from your prescriber or pharmacist. Never start, stop, or change a medication without talking to your healthcare provider. In an emergency, call 911.