Unichem Pharmaceuticals USA Inc.

4 FDA enforcement actions

4 Total Recalls

1 Class I

1 Class II

2 Class III

Firm Details

Product Types: drug
States: NJ

All Recalls

Class II: Risk 01/21/2026 drug

cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Class I: Dangerous 08/27/2025 drug

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 drug

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 drug

Discoloration

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.