Unichem Pharmaceuticals USA Inc.: Drug Recall

Recall #D-0301-2026 · 01/21/2026

Class II: Risk

Recall Details

Recall Number: D-0301-2026
Classification: Class II
Product Type: Drug
Recalling Firm: Unichem Pharmaceuticals USA Inc.
Status: Ongoing
Date Initiated: 01/21/2026
Location: East Brunswick, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Reason for Recall

cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.

Product Description

Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01

Distribution Pattern

US Nationwide and PR.

Other Recalls by Unichem Pharmaceuticals USA Inc.

Class I: Dangerous 08/27/2025

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).
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.