Unichem Pharmaceuticals (USA), Inc.

• QuetiapineSeroquel, Seroquel XR · 11 products
• PregabalinLyrica, Lyrica CR · 8 products
• Sotalol hydrochlorideBetapace, Sotalol Hydrochloride Af, Betapace Af · 6 products
• AripiprazoleAbilify, Opipza, Abilify Asimtufii · 6 products
• Pramipexole dihydrochloride6 products
• BuspironeBucapsol · 6 products
• Amitriptyline hydrochloride6 products
• GuanfacineIntuniv · 6 products
• Divalproex sodiumDepakote, Depakote ER, Depakote Sprinkles · 5 products
• CelecoxibCelebrex, Vyscoxa, Elyxyb - Celecoxib · 4 products
• Rizatriptan benzoateRizafilm, Maxalt-Mlt, Maxalt · 4 products
• TadalafilCialis, Tadliq, Adcirca · 4 products
• Tolterodine tartrateDetrol · 4 products
• Metformin hydrochlorideGlumetza · 4 products
• CarvedilolCoreg, Coreg CR · 4 products
• NebivololBystolic · 4 products
• LamotrigineLamictal, Lamictal XR, Subvenite · 4 products
• TopiramateTopamax, Qudexy XR, Trokendi XR · 4 products
• Donepezil hydrochlorideAricept · 4 products
• HydrochlorothiazideInzirqo · 4 products
• DoxazosinCardura, Cardura XL · 4 products
• LacosamideVimpat, Motpoly XR · 4 products
• ValsartanDiovan · 4 products
• AmlodipineNorvasc, Sdamlo, Norliqva · 3 products
• Nadolol3 products
• ClonidineClonidine Transdermal System, Catapres-Tts-1, Clonidine Transdermal System Usp, 0.1 Mg/Day · 3 products
• IrbesartanAvapro · 3 products
• LabetalolLabetalol HCL in Dextrose · 3 products
• PioglitazoneActos · 3 products
• Losartan potassium and hydrochlorothiazideHyzaar · 3 products
• AtenololTenormin · 3 products
• Cyclobenzaprine hydrochlorideAmrix, Tonmya, Fexmid · 3 products
• ZonisamideZonegran, Zonisade · 3 products
• Bisoprolol fumarate and hydrochlorothiazide3 products
• MontelukastSingulair · 3 products
• Metolazone3 products
• Flecainide acetate3 products
• Losartan potassiumLosortan Potassium, Cozaar, Arbli · 3 products
• BaclofenGablofen, Lyvispah, Baclofen (Intrathecal) · 3 products
• MeloxicamZybic, Xifyrm, Qamzova · 2 products
• Zaleplon2 products
• MetronidazoleMetronidazole Vaginal, Metronidazole Vaginal Gel, Likmez · 2 products
• RanolazineAspruzyo Sprinkle · 2 products
• PrasugrelEffient · 2 products
• ChlorthalidoneThalitone, Hemiclor · 2 products
• Atenolol and chlorthalidone2 products
• Bisoprolol fumarate2 products
• TizanidineZanaflex, Ontralfy · 2 products
• Memantine hydrochloride2 products
• Irbesartan and hydrochlorothiazideAvalide · 2 products
• AllopurinolAloprim · 2 products
• Piroxicam2 products
• Solifenacin succinate2 products
• Etodolac2 products
• MethocarbamolRobaxin, Atmeksi, Tanlor · 2 products
• Pindolol2 products
• Methscopolamine bromide2 products
• Primaquine phosphate1 product
• CarbamazepineTegretol XR, Equetro, Carbatrol · 1 product
• Amiodarone hydrochloridePacerone, Nexterone · 1 product
• Diphenoxylate hydrochloride and atropine sulfateLomotil · 1 product
• Alfuzosin hydrochlorideUroxatral · 1 product
• PhenytoinDilantin, Phenytek, Phenytoin Infatabs · 1 product
• Cyproheptadine1 product
• Tramadol hydrochlorideConzip · 1 product

• ANDA: Abbreviated New Drug Application: how a generic version is approved.

The sponsor is the company that holds the FDA application; it can differ from the labeler.

2026

1. April 13, 2026 · Class III · Ongoing · D-0511-2026 · Buspirone

   Subpotent drug

   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

2. January 21, 2026 · Class III · Ongoing · D-0306-2026 · Doxazosin

   Tablets/Capsules Imprinted with Wrong ID

   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

3. January 21, 2026 · Class II · Ongoing · D-0301-2026 · Bisoprolol fumarate and hydrochlorothiazide

   cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.

   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:

2025

1. August 27, 2025 · Class I · Ongoing · D-0655-2025 · Cyclobenzaprine hydrochloride

   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).

   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),

2022

1. September 19, 2022 · Class III · Terminated · D-1541-2022 · Clonidine

   Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,

   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)

2021

1. October 25, 2021 · Class III · Terminated · D-0255-2022 · Topiramate

   Discoloration

   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 Brunswi

2020

1. August 19, 2020 · Class II · Terminated · D-1544-2020 · Metformin hydrochloride

   CGMP Deviations

   Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-129-01

2. August 19, 2020 · Class II · Terminated · D-1543-2020 · Metformin hydrochloride

   CGMP Deviations

   Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-128-10

3. May 26, 2020 · Class III · Terminated · D-1291-2020 · Clonidine

   Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.

   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)

4. January 29, 2020 · Class III · Terminated · D-0829-2020 · Clonidine

   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.

   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

2017

1. December 19, 2017 · Class II · Terminated · D-0228-2018 · Divalproex sodium

   Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.

   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

2. October 2, 2017 · Class II · Terminated · D-0010-2018 · Bisoprolol fumarate

   Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.

   Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa, 403 511, India, Marketed by: UNICHEM PHARMACEUTICALS, (USA), INC. Hasbr

2016

1. August 19, 2016 · Class III · Terminated · D-1519-2016 · Lamotrigine

   Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.

   Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), In

2015

1. July 30, 2015 · Class II · Terminated · D-1352-2015 · Hydrochlorothiazide

   Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.

   Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Marketed by: UNICHEM PHARMACEUTICALS (USA), INC. Roche

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

FDA Enforcement Report search → · Report an error →