# FDA recall D-0121-2024

> **Apotex Corp.** · Class II · drug recall initiated 2023-11-01.

## Product

Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.

## Reason for recall

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0121-2024
- **Recalling firm:** Apotex Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-11-01
- **Report date:** 2023-12-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Weston, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0121-2024

## Citation

> AI Analytics. FDA recall D-0121-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0121-2024. Source: US FDA. Licensed CC0.

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