Unichem Pharmaceuticals USA Inc.: Drug Recall

Recall #D-0655-2025 · 08/27/2025

Class I: Dangerous

Recall Details

Recall Number: D-0655-2025
Classification: Class I
Product Type: Drug
Recalling Firm: Unichem Pharmaceuticals USA Inc.
Status: Ongoing
Date Initiated: 08/27/2025
Location: East Brunswick, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 230 90-count bottles

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).

Product Description

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.

Distribution Pattern

Nationwide within the U.S.A

Other Recalls by Unichem Pharmaceuticals USA Inc.

Class II: Risk 01/21/2026

cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Class III: Low Risk 09/19/2022

Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Class III: Low Risk 10/25/2021

Discoloration

View all recalls by Unichem Pharmaceuticals USA Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.