Sertraline Hydrochloride recalls

Sertraline Hydrochloride products have been recalled 2 times, most recently on 17 Dec 2025. The recalling company is usually Legacy Pharmaceutical Packaging. The most common reason is packaging defects.

Total recalls2since 2024

Last 12 months1reported

Class I00% of total

Ongoing2latest 17 Dec 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 1 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why sertraline hydrochloride is recalled

Packaging Defects150%
Manufacturing (CGMP) Deviations150%

Companies

Product types

Antidepressants2100%

By year

2025150%
2024150%

Ongoing sertraline hydrochloride recalls

2 active

Reported	Class	Recall	Company	Reason	Where
17 Dec 2025Drug	CLASS II	Sertraline Hydrochloride Tablets USP, 100 mg recalledSertraline Hydrochloride	Lupin Pharmaceuticals	Packaging Defects	Nationwide
3 Jan 2024Drug	CLASS II	Sertraline Tablets, USP 100 mg recalled by Legacy PharmaceuticalSertraline Hydrochloride	Legacy Pharmaceutical Packaging	Manufacturing (CGMP) Deviations	AR, CA

All sertraline hydrochloride recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
17 Dec 2025Drug	CLASS II	Sertraline Hydrochloride Tablets USP, 100 mg recalledSertraline Hydrochloride	Lupin Pharmaceuticals	Packaging Defects	Nationwide
3 Jan 2024Drug	CLASS II	Sertraline Tablets, USP 100 mg recalled by Legacy PharmaceuticalSertraline Hydrochloride	Legacy Pharmaceutical Packaging	Manufacturing (CGMP) Deviations	AR, CA

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.