Anxiety & Sleep Medication recalls

The FDA has published 132 recalls involving anxiety & sleep medication since 2012. The latest was reported on 1 Jul 2026. Most were for potency & assay. Hikma Pharmaceuticals USA has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls132since 2012

Last 12 months3reported

Class I65% of total

Ongoing19latest 1 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 4 3Feb 1 0 0May 0 0 1Aug 0 0 0Nov 0 0 0Feb 0 1 1May 0 1 0Aug 0 0

Severity split

Class I 6 5%Class II 108 82%Class III 18 14%

Why anxiety & sleep medication is recalled

Companies

Brands

By year

202632%
202597%
202443%
20232116%
20221914%
202132%
202032%
201932%
201843%
201765%

Ongoing anxiety & sleep medication recalls

19 active

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS III	hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/ (1 Pint) recalledHydroxyzine Hydrochloride	ANI Pharmaceuticals	Other	Nationwide
13 May 2026Drug	CLASS III	busPIRone Hydrochloride Tablets, USP, 5 mg recalledBuspirone Hydrochloride	Unichem Pharmaceuticals USA	Potency & Assay	Nationwide
15 Apr 2026Drug	CLASS II	Xanax XR, alprazolam, extended-release tablets, 3 mg recalled by ViatrisXanax	Viatris	Potency & Assay	Nationwide
6 Aug 2025Drug	CLASS II	Lorazepam Injection, USP, 2 mg/mL, 25 x vials/carton recalledLorazepam	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide
12 Mar 2025Drug	CLASS II	Lorazepam 0.5 mg per Oral Syringe, Delivers:, Oral Concentrate recalled	Safecor Health	Packaging Defects	Nationwide
26 Feb 2025Drug	CLASS II	Lorazepam Tablets, USP, 2mg, Unit Dose per carton ( blister packs) recalled	The Harvard Drug Group	Potency & Assay	Nationwide

All anxiety & sleep medication recalls, newest first

132 total

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS III	hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/ (1 Pint) recalledHydroxyzine Hydrochloride	ANI Pharmaceuticals	Other	Nationwide
13 May 2026Drug	CLASS III	busPIRone Hydrochloride Tablets, USP, 5 mg recalledBuspirone Hydrochloride	Unichem Pharmaceuticals USA	Potency & Assay	Nationwide
15 Apr 2026Drug	CLASS II	Xanax XR, alprazolam, extended-release tablets, 3 mg recalled by ViatrisXanax	Viatris	Potency & Assay	Nationwide
6 Aug 2025Drug	CLASS II	Lorazepam Injection, USP, 2 mg/mL, 25 x vials/carton recalledLorazepam	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide
12 Mar 2025Drug	CLASS II	Lorazepam 0.5 mg per Oral Syringe, Delivers:, Oral Concentrate recalled	Safecor Health	Packaging Defects	Nationwide
26 Feb 2025Drug	CLASS II	Lorazepam Tablets, USP, 2mg, Unit Dose per carton ( blister packs) recalled	The Harvard Drug Group	Potency & Assay	Nationwide
26 Feb 2025Drug	CLASS II	Lorazepam Tablets, USP, 1mg, Unit Dose per carton ( blister packs) recalled	The Harvard Drug Group	Potency & Assay	Nationwide
26 Feb 2025Drug	CLASS II	Lorazepam Tablets, USP, 0.5mg, Unit Dose per carton ( blister packs) recalled	The Harvard Drug Group	Potency & Assay	Nationwide
15 Jan 2025Drug	CLASS I	Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV recalledClonazepam	Endo USA	Labeling Errors	Nationwide
15 Jan 2025Drug	CLASS I	Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV recalledClonazepam	Endo USA	Labeling Errors	Nationwide
15 Jan 2025Drug	CLASS I	Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV recalledClonazepam	Endo USA	Labeling Errors	Nationwide
15 Jan 2025Drug	CLASS I	Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV recalledClonazepam	Endo USA	Labeling Errors	Nationwide
7 Aug 2024Drug	CLASS I	Clonazepam Orally Disintegrating Tablets recalledClonazepam	Endo Pharmaceuticals	Labeling Errors	Nationwide
10 Jul 2024Drug	CLASS III	Eszopiclone Tablets, USP 1mg CIV recalled by Dr. Reddy's LaboratoriesEszopiclone	Dr. Reddy's Laboratories	Potency & Assay	MS, OH
31 Jan 2024Drug	CLASS II	Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg recalledZolpidem Tartrate	SUN Pharmaceutical Industries	Sterility	Nationwide
31 Jan 2024Drug	CLASS II	Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg recalledZolpidem Tartrate	SUN Pharmaceutical Industries	Sterility	Nationwide
29 Nov 2023Drug	CLASS III	Buspirone Hydrochloride Tabs USP 10 mg recalledBuspirone Hydrochloride	NCS Healthcare of Kentucky	Packaging Defects	Nationwide
7 Jun 2023Drug	CLASS II	Lorazepam Oral Concentrate, USP, 2mg per mL recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Lorazepam Injection, USP 2 mg/mL vial vials recalled by Akorn	Akorn	Potency & Assay	Nationwide
24 May 2023Drug	CLASS II	Lorazepam Injection, USP, 2mg/mL vial recalledLorazepam	Hikma Pharmaceuticals USA	Potency & Assay	Nationwide
24 May 2023Drug	CLASS II	LORazepam Injection, 2mg / mL Single Dose vial recalled by RemedyRepack	RemedyRepack	Manufacturing (CGMP) Deviations	PA
3 May 2023Drug	CLASS II	BusPIRone Hydrochloride Tablets USP, 7.5 mg recalledBuspirone Hydrochloride	Northwind Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Alprazolam C-IV, 0.5 mg, 30 Tabs recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Alprazolam Tab, USP 0.5mg, (CIV) recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Alprazolam Tab, USP 1mg, (CIV) recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Alprazolam Tab, USP 0.25mg, (CIV) recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Alprazolam C-IV, 2 mg, 60 Tabs recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Alprazolam C-IV, 1 mg recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	Nationwide
22 Mar 2023Drug	CLASS II	Alprazolam Tablets, USP, 2 mg, CIV recalled	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
22 Mar 2023Drug	CLASS II	Alprazolam Tablets, USP, 0.5mg, CIV recalled	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide

Should you stop taking Anxiety & Sleep Medication?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.

Alert me about Anxiety & Sleep Medication

One email the day a new recall is posted for Anxiety & Sleep Medication. Unsubscribe any time.

At a glance

Latest recall: 1 Jul 2026
First on record: 20 Jun 2012
Class I share: 5%
Ongoing: 19

Drug classes

Injectable & IV Drugs 4,623Pain Medication 1,518Creams, Ointments & Gels 928Blood Pressure Medication 837Compounded Drugs 721Eye Drops 600Hormones & Birth Control 494Antibiotics 492Allergy Medication 348Stomach & Acid Reflux Medication 313Cold & Cough Medicine 312Thyroid Medication 242

Recall classes

CLASS ISerious harm or death possible.

CLASS IITemporary or reversible harm.

CLASS IIIUnlikely to cause harm.