Unichem Pharmaceuticals recalls
FDA enforcement reports naming Unichem Pharmaceuticals Usa Inc as the recalling firm.
- Recall reports
- 12
- Class I (serious)
- 1
- Most recent report
- May 13, 2026
- May 13, 2026busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by…Drug · Unichem Pharmaceuticals USA Inc.Subpotent drugClass III
- Feb 18, 2026Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem…Drug · Unichem Pharmaceuticals USA Inc.Tablets/Capsules Imprinted with Wrong IDClass III
- Feb 11, 2026Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2Drug · Unichem Pharmaceuticals USA Inc.cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.Class II
- Sep 24, 2025Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufac…Drug · Unichem Pharmaceuticals USA Inc.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 I
- Sep 28, 2022Clonidine Hydrochloride Tablets, USP, 0Drug · UNICHEM PHARMACEUTICALS USA INCProduct 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
- Dec 1, 2021Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Lab…Drug · UNICHEM PHARMACEUTICALS USA INCDiscolorationClass III
- Jun 17, 2020Clonidine Hydrochloride Tablets, USP 0Drug · UNICHEM PHARMACEUTICALS USA INCFailed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.Class III
- Feb 12, 2020Clonidine Hydrochloride Tablets, USP 0Drug · UNICHEM PHARMACEUTICALS USA INCFailed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.Class III
- Jan 24, 2018Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manuf…Drug · Unichem Pharmaceuticals Usa IncCross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.Class II
- Oct 25, 2017Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHE…Drug · Unichem Pharmaceuticals Usa IncFailed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.Class II
- Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured…
- Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNI…
Page 1 of 2