Unichem Pharmaceuticals Usa recalls

Unichem Pharmaceuticals Usa appears in 12 official U.S. recall notices indexed by RecallRadar, most recently on 2026-05-13.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, G…
  FDA Drug · Class III · 2026-05-13 · Unichem Pharmaceuticals Usa
  Reason: Subpotent drug
• Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevar…
  FDA Drug · Class III · 2026-02-18 · Unichem Pharmaceuticals Usa
  Reason: Tablets/Capsules Imprinted with Wrong ID
• Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS L…
  FDA Drug · Class II · 2026-02-11 · Unichem Pharmaceuticals Usa
  Reason: cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
• Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind
  FDA Drug · Class I · 2025-09-24 · Unichem Pharmaceuticals Usa
  Reason: 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).
• Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind
  FDA Drug · Class III · 2022-09-28 · Unichem Pharmaceuticals Usa
  Reason: Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
• Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind
  FDA Drug · Class III · 2021-12-01 · Unichem Pharmaceuticals Usa
  Reason: Discoloration
• Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind
  FDA Drug · Class III · 2020-06-17 · Unichem Pharmaceuticals Usa
  Reason: Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
• Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd
  FDA Drug · Class III · 2020-02-12 · Unichem Pharmaceuticals Usa
  Reason: 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.
• Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd
  FDA Drug · Class II · 2018-01-24 · Unichem Pharmaceuticals Usa
  Reason: Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
• Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind
  FDA Drug · Class II · 2017-10-25 · Unichem Pharmaceuticals Usa
  Reason: Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
• Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind
  FDA Drug · Class III · 2016-10-05 · Unichem Pharmaceuticals Usa
  Reason: Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
• Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind
  FDA Drug · Class II · 2015-09-02 · Unichem Pharmaceuticals Usa
  Reason: Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.