# FDA recall D-0923-2023

> **Dr Reddy's Laboratories Limited** · Class II · drug recall initiated 2023-06-21.

## Product

Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10

## Reason for recall

Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0923-2023
- **Recalling firm:** Dr Reddy's Laboratories Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-06-21
- **Report date:** 2023-07-26

- **Voluntary/Mandated:** N/A
- **Location:** Ranasthalam Mandal, Srikakulam, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0923-2023

## Citation

> AI Analytics. FDA recall D-0923-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0923-2023. Source: US FDA. Licensed CC0.

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