Sleep: FDA Approvals, Recalls, 510(k) Clearances and Side Effect…

4drug recalls (since 1 Jan 2023)
12device recalls (since 1 Jan 2023)
38510(k) clearances (since 1 Jan 2023)
14,022side effect reports (reports received since 1 Jan 2023)

Each number has its full source under its own list below.

Drug recalls

4 recalls (since 1 Jan 2023). Recalls of medicines for this topic, newest first.

At the source

25Jul2025
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactu…
Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
D-0566-2025
4Jun2024
Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30
Reason: Failed Impurities/Degradation Specifications: Related Substances
D-0581-2024
18Jan2024
Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 0851…
Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
D-0272-2024
18Jan2024
Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 085…
Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
D-0271-2024

Source: openFDA, Drug recall enforcement reports, since 1 Jan 2023. Retrieved 12 Nov 2026.

Device recalls

12 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.

At the source

29Sep2026
Ventilatory Effort Recorder
Reason: The device may be unable to correctly format its internal memory. When the internal memory cannot be correctly formatted, previously recorded studies may remain on the device and may be updated with…
Z-0319-2027
7Aug2026
Infant Supine Sleep System
Reason: Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
Z-3175-2026
7Aug2026
Infant Supine Sleep System
Reason: Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
Z-3176-2026
11May2026
Stimulator, Hypoglossal Nerve, Implanted, Apnea
Reason: Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in u…
Z-2516-2026
27Apr2026
Device, Anti-Snoring
Reason: Due to device not having FDA Clearance
Z-2769-2026
9Oct2025
Device, Anti-Snoring
Reason: Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
Z-0956-2026
23Jun2025
Ventricular (Assist) Bypass
Reason: Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
Z-2290-2025
23Jun2025
Ventricular (Assist) Bypass
Reason: Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
Z-2291-2025
15May2024
Infant Supine Sleep System
Reason: This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.
Z-2882-2026
7Feb2024
Media, Electroconductive
Reason: Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall related to their Tensive Conductive Adhesive Gel, Ref. 22-60 Lot Number A0623009. They h…
Z-1306-2024