# FDA recall D-0878-2023

> **The Harvard Drug Group** · Class II · drug recall initiated 2023-06-16.

## Product

Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61

## Reason for recall

Packaging defect: blister packaging inadequately sealed.

## Distribution

Nationwide in the U.S.

## Key facts

- **Recall number:** D-0878-2023
- **Recalling firm:** The Harvard Drug Group
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-06-16
- **Report date:** 2023-07-05
- **Termination date:** 2024-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** La Vergne, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0878-2023

## Citation

> AI Analytics. FDA recall D-0878-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0878-2023. Source: US FDA. Licensed CC0.

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