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Unichem Pharmaceuticals USA Recalls
12 recalls on record · September 2, 2015 to May 13, 2026 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 13, 2026DrugsFDA
Unichem Pharmaceuticals USA Inc. recalls busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, A
Hazard: Subpotent drug
February 18, 2026DrugsFDA
Unichem Pharmaceuticals USA Inc. recalls Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 To
Hazard: Tablets/Capsules Imprinted with Wrong ID
February 11, 2026DrugsFDA
Unichem Pharmaceuticals USA Inc. recalls Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UN
Hazard: cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
September 24, 2025DrugsFDA
Unichem Pharmaceuticals USA Inc. recalls Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, L
Hazard: 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).
September 28, 2022DrugsFDA
UNICHEM PHARMACEUTICALS USA INC recalls Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pile
Hazard: Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
December 1, 2021DrugsFDA
UNICHEM PHARMACEUTICALS USA INC recalls Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut
Hazard: Discoloration
June 17, 2020DrugsFDA
UNICHEM PHARMACEUTICALS USA INC recalls Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Piler
Hazard: Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
February 12, 2020DrugsFDA
UNICHEM PHARMACEUTICALS USA INC recalls Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilern
Hazard: Failed 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.
January 24, 2018DrugsFDA
Unichem Pharmaceuticals Usa Inc recalls Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories
Hazard: Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
October 25, 2017DrugsFDA
Unichem Pharmaceuticals Usa Inc recalls Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind.
Hazard: Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
October 5, 2016DrugsFDA
Unichem Pharmaceuticals Usa Inc recalls Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pi
Hazard: Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
September 2, 2015DrugsFDA
Unichem Pharmaceuticals Usa Inc recalls Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne In
Hazard: Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.