# FDA recall D-0655-2025

> **Unichem Pharmaceuticals USA Inc.** · Class I · drug recall initiated 2025-08-27.

## Product

Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only,    Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19.

## Reason for recall

Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).

## Distribution

Nationwide within the U.S.A

## Key facts

- **Recall number:** D-0655-2025
- **Recalling firm:** Unichem Pharmaceuticals USA Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-08-27
- **Report date:** 2025-09-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Brunswick, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0655-2025

## Citation

> AI Analytics. FDA recall D-0655-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0655-2025. Source: US FDA. Licensed CC0.

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