CLASS II ONGOING Drug recall · Reported 3 Jan 2024 · FDA Enforcement Report
Sertraline Tablets, USP 100 mg recalled by Legacy Pharmaceutical
Legacy Pharmaceutical Packaging is recalling Sertraline Tablets, USP 100 mg per, distributed in Arkansas, California. The recall was initiated on 11 Dec 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0205-2024
- FDA event ID
- 93605
- Recalling firm
- Legacy Pharmaceutical Packaging, Earth City, MO
- Manufacturer
- Legacy Pharmaceutical Packaging, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Dec 2023
- FDA classified
- 26 Dec 2023
- Reported
- 3 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Antidepressants
Timeline
| 11 Dec 2023 | Recall initiated by company | |
| 26 Dec 2023 | Classified by FDA | +15 days |
| 3 Jan 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Product as listed by the FDA
Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, Packaged by: Legacy Pharmaceutical Packaging LLC., Earth City, MO 63045, NDC# 68645-523-54
Where it was distributed
CA and AR
Stores named: Walmart
Questions about this recall
Why was it recalled?
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Which lots are affected?
Lot #: 222033, exp. date 08/31/2024
Where was it sold?
CA and AR
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Legacy Pharmaceutical Packaging
All 12Other Sertraline recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sertraline Hydrochloride Tablets USP, 100 mg recalledSertraline Hydrochloride | Lupin Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | sertraline HCl tablets, 25 mg recalled by Greenstone | Greenstone | Other | Nationwide |
| Drug | CLASS II | Sertraline HCL Tablet, 50 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |