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Unichem Pharmaceuticals USA Inc. FDA Recalls
6 recalls on file across drugs, 1 of them Class I and 4 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, AClass IIIApr 13, 2026Subpotent drug |
| Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNClass IIJan 21, 2026cGMP Deviations: recall due to not meeting the N-Nitroso Bis |
| Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 ToClass IIIJan 21, 2026Tablets/Capsules Imprinted with Wrong ID |
| Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, LClass IAug 27, 2025Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90- |
| Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. PileClass IIISep 19, 2022Product mix-up:0.2 mg strength Clonidine Hydrochloride Table |
| Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Class IIIOct 25, 2021Discoloration |