East Brunswick, NJ, United States
UNICHEM PHARMACEUTICALS USA INC recalls
9 recalls recorded since 2018, most recently on 13 April 2026. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls9
Ongoing (FDA)4
Terminated or completed5
Class I (FDA)1
Ongoing Class III Drugs
- Recall started
- 13 April 2026
- Reason
- Subpotent drug
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0511-2026
- busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. Ea
Ongoing Class II Drugs
- Recall started
- 21 January 2026
- Reason
- cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
- Distribution
- US Nationwide and PR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0301-2026
- Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for:
Ongoing Class III Drugs
- Recall started
- 21 January 2026
- Reason
- Tablets/Capsules Imprinted with Wrong ID
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0306-2026
- Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by Unichem Laboratories
Ongoing Class I Drugs
- Recall started
- 27 August 2025
- 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).
- Distribution
- Nationwide within the U.S.A
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0655-2025
- Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA
Terminated Class III Drugs
- Recall started
- 19 September 2022
- Terminated
- 2 March 2023
- 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,
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1541-2022
- Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: UNICHEM PHARMACEUTICALS (USA)
Terminated Class III Drugs
- Recall started
- 25 October 2021
- Terminated
- 12 October 2022
- Reason
- Discoloration
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0255-2022
- Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Unichem Pharmaceuticals (USA), Inc., East Brunsw
Terminated Class III Drugs
- Recall started
- 26 May 2020
- Terminated
- 8 January 2021
- Reason
- Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1291-2020
- Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for : Unichem Pharmaceuticals (USA)
Terminated Class III Drugs
- Recall started
- 29 January 2020
- Terminated
- 8 January 2021
- 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.
- Distribution
- Distributed Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0829-2020
- Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilerne Ind. Estate, Pilerne Bardez, Goa 403 511 India. Manufactured for: Unichem Pharmaceuticals (USA), I
Terminated Class II Drugs
- Recall started
- 19 December 2017
- Terminated
- 12 September 2018
- Reason
- Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
- Distribution
- Product was distributed nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0228-2018
- Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Pharmaceuticals (USA), I
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.