Drug company (FDA labeler)
Micro Labs Limited
NDC labeler code: 42571
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Glimepiride6 products
- Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideTribenzor · 5 products
- Dapagliflozin and metformin hydrochlorideXigduo XR · 4 products
- CelecoxibCelebrex, Vyscoxa, Elyxyb - Celecoxib · 4 products
- Amlodipine and olmesartan medoxomilAzor · 4 products
- TimololTimoptic in Ocudose, Timoptic-Xe, Timoptic · 3 products
- Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)Augmentin Es-600, Augmentin · 3 products
- Olmesartan medoxomil and hydrochlorothiazideBenicar Hct · 3 products
- Clomipramine hydrochlorideAnafranil · 3 products
- FurosemideLasix, Furoscix, Lasix Onyu · 3 products
- Metformin hydrochlorideGlumetza · 3 products
- ClindamycinCleocin Phosphate, Cleocin Hydrochloride, Clindamycin Phoaphate Topical Solution Usp, 1% · 3 products
- Diphenhydramine3 products
- Sapropterin dihydrochlorideKuvan, Javygtor, Zelvysia · 2 products
- RoflumilastZoryve, Daliresp · 2 products
- Piroxicam2 products
- AmoxicillinAmoxil · 2 products
- Isoproterenol hydrochloride2 products
- Tranexamic acidCyklokapron · 2 products
- DapagliflozinFarxiga · 2 products
- TofacitinibXeljanz, Xeljanz XR · 2 products
- RufinamideBanzel · 2 products
- Varenicline tartrateChantix, Tyrvaya · 2 products
- ClobazamSympazan, Onfi · 2 products
- MidazolamNayzilam · 2 products
- Brimonidine tartrateAlphagan P, Mirvaso · 2 products
- RasagilineAzilect · 2 products
- Methazolamide2 products
- PirfenidoneEsbriet · 2 products
- Dorzolamide hydrochloride and timolol maleateCosopt, Dorzolamide Hydrochloride Timolol Maletae, Cosopt Pf · 2 products
- Caffeine citrate2 products
- Diclofenac sodium and misoprostolArthrotec, Dicloenac Sodium and Misoprostol DR · 2 products
- Bisoprolol fumarate2 products
- Cromolyn sodiumGastrocrom · 1 product
- Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 1 product
- Methenamine hippurate1 product
- LincomycinLincocin · 1 product
- Carboprost tromethamineHemabate · 1 product
- Sodium nitroprussideNipride Rtu · 1 product
- Arformoterol tartrate1 product
Show the other 31 medicines
- Proparacaine hydrochlorideAlcaine · 1 product
- CholestyramineQuestran, Prevalite, Cholestyramine Light · 1 product
- Nevirapine1 product
- Dorzolamide hydrochloride1 product
- Mefenamic acid1 product
- Clobetasol propionateClobetasol Propionate (Emollient), Byqlovi, Tovet (Emollient Formulation) · 1 product
- SuccinylcholineAnectine, Quelicin · 1 product
- Triamcinolone acetonideKenalog-40, Triderm, Triesence · 1 product
- Nitrofurantoin1 product
- TobramycinTobramycin Inhalation Solution Pak, Tobi, Tobi Podhaler · 1 product
- FamotidinePepcid · 1 product
- Acetazolamide1 product
- ColchicineColcrys, Gloperba, Lodoco · 1 product
- Chlordiazepoxide hydrochloride and clidinium bromideLibrax · 1 product
- DalfampridineAmpyra · 1 product
- LevetiracetamKeppra, Spritam, Keppra XR · 1 product
- BrivaracetamBriviact · 1 product
- LatanoprostIyuzeh, Xalatan, Xelpros · 1 product
- RivaroxabanXarelto · 1 product
- RamelteonRozerem · 1 product
- ValganciclovirValcyte · 1 product
- Verapamil hydrochloride1 product
- OfloxacinOcuflox · 1 product
- Formoterol fumaratePerforomist · 1 product
- Levocetirizine dihydrochlorideXyzal · 1 product
- BimatoprostLumigan, Latisse, Durysta · 1 product
- Travoprost ophthalmic solutionTravatan Z, Idose Tr, Travoprost Ophthalmic Soluton · 1 product
- TafluprostZioptan · 1 product
- Aspirin and extended-release dipyridamole1 product
- NicardipineCardene IV · 1 product
- DexamethasoneTaperdex 6-Day, Hemady, Taperdex 12-Day · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| June 30, 2026 | ANDA208334 | Rivaroxaban RIVAROXABAN | Micro Labs |
| May 7, 2026 | ANDA218558 | Brimonidine tartrate BRIMONIDINE TARTRATE | Micro Labs |
| April 13, 2026 | ANDA206371 | Olmesartan medoxomil and hydrochlorothiazide OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Micro Labs |
| April 8, 2026 | ANDA218557 | Ofloxacin OFLOXACIN | Micro Labs |
| April 6, 2026 | ANDA211466 | Dapagliflozin and metformin hydrochloride DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | Micro Labs |
| April 6, 2026 | ANDA211467 | Dapagliflozin DAPAGLIFLOZIN | Micro Labs |
| March 19, 2026 | ANDA218838 | Valganciclovir VALGANCICLOVIR HYDROCHLORIDE | Micro Labs |
| March 9, 2026 | ANDA218303 | Bisoprolol fumarate BISOPROLOL FUMARATE | Micro Labs |
| March 5, 2026 | ANDA219318 | Cholestyramine CHOLESTYRAMINE | Micro Labs |
| February 23, 2026 | ANDA214880 | Brivaracetam BRIVARACETAM | Micro Labs |
| February 17, 2026 | ANDA212880 | Colchicine COLCHICINE | Micro Labs |
| January 8, 2026 | ANDA218188 | Furosemide FUROSEMIDE | Micro Labs |
| January 8, 2026 | ANDA219511 | Sapropterin dihydrochloride SAPROPTERIN DIHYDROCHLORIDE | Micro Labs |
| November 24, 2025 | ANDA207437 | Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | Micro Labs |
| October 29, 2025 | ANDA218302 | Varenicline tartrate VARENICLINE TARTRATE | Micro Labs |
| October 20, 2025 | ANDA219294 | Proparacaine hydrochloride PROPARACAINE HYDROCHLORIDE | Micro Labs |
| August 22, 2025 | ANDA219845 | Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE | Micro Labs |
| April 14, 2025 | ANDA219306 | Latanoprost LATANOPROST | Micro Labs |
| March 7, 2025 | ANDA218555 | Arformoterol tartrate ARFORMOTEROL TARTRATE | Micro Labs |
| June 26, 2024 | ANDA218304 | Formoterol fumarate FORMOTEROL FUMARATE | Micro Labs |
| April 3, 2024 | ANDA218013 | Carboprost tromethamine CARBOPROST TROMETHAMINE | Micro Labs |
| March 27, 2024 | ANDA217797 | Dexamethasone DEXAMETHASONE SODIUM PHOSPHATE | Micro Labs |
| November 22, 2023 | ANDA217846 | Brimonidine tartrate BRIMONIDINE TARTRATE | Micro Labs |
| November 3, 2023 | ANDA217073 | Nitrofurantoin NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Micro Labs |
| September 14, 2023 | ANDA217842 | Famotidine FAMOTIDINE | Micro Labs |
Show the other 53 applications
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| August 21, 2023 | ANDA217504 | Midazolam MIDAZOLAM HYDROCHLORIDE | Micro Labs |
| July 27, 2023 | ANDA217344 | Tobramycin TOBRAMYCIN | Micro Labs |
| July 7, 2023 | ANDA216420 | Nicardipine NICARDIPINE HYDROCHLORIDE | Micro Labs |
| May 26, 2023 | ANDA217343 | Timolol TIMOLOL MALEATE | Micro Labs |
| May 15, 2023 | ANDA216688 | Rufinamide RUFINAMIDE | Micro Labs |
| March 13, 2023 | ANDA209738 | Tofacitinib TOFACITINIB CITRATE | Micro Labs |
| February 9, 2023 | ANDA215243 | Ramelteon RAMELTEON | Micro Labs |
| January 10, 2023 | ANDA212448 | Metformin hydrochloride METFORMIN HYDROCHLORIDE | Micro Labs |
| September 7, 2022 | ANDA216596 | Timolol TIMOLOL MALEATE | Micro Labs |
| July 19, 2022 | ANDA215835 | Chlordiazepoxide hydrochloride and clidinium bromide CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE | Micro Labs |
| June 24, 2022 | ANDA207471 | Amoxicillin AMOXICILLIN | Micro Labs |
| May 18, 2022 | ANDA212680 | Pirfenidone PIRFENIDONE | Micro Labs |
| January 25, 2022 | ANDA215936 | Dorzolamide hydrochloride and timolol maleate DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | Micro Labs |
| November 8, 2021 | ANDA215082 | Lincomycin LINCOMYCIN HYDROCHLORIDE | Micro Labs |
| August 11, 2021 | ANDA209929 | Aspirin and extended-release dipyridamole ASPIRIN AND DIPYRIDAMOLE | Micro Labs |
| July 15, 2021 | ANDA204355 | Diclofenac sodium and misoprostol DICLOFENAC SODIUM AND MISOPROSTOL | Micro Labs |
| March 19, 2021 | ANDA203767 | Travoprost ophthalmic solution TRAVOPROST | Micro Labs |
| February 16, 2021 | ANDA210845 | Isoproterenol hydrochloride ISOPROTERENOL HYDROCHLORIDE | Micro Labs |
| November 24, 2020 | ANDA214879 | Succinylcholine SUCCINYLCHOLINE CHLORIDE | Micro Labs |
| October 1, 2020 | ANDA207401 | Acetazolamide ACETAZOLAMIDE | Micro Labs Ltd India |
| September 8, 2020 | ANDA202505 | Bimatoprost BIMATOPROST | Micro Labs |
| June 22, 2020 | ANDA213219 | Clomipramine hydrochloride CLOMIPRAMINE HYDROCHLORIDE | Micro Labs |
| May 28, 2020 | ANDA204777 | Dorzolamide hydrochloride and timolol maleate DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | Micro Labs |
| March 3, 2020 | ANDA211309 | Metformin hydrochloride METFORMIN HYDROCHLORIDE | Saptalis Pharms |
| December 16, 2019 | ANDA213202 | Caffeine citrate CAFFEINE CITRATE | Micro Labs |
| November 8, 2019 | ANDA204778 | Dorzolamide hydrochloride DORZOLAMIDE HYDROCHLORIDE | Micro Labs |
| October 2, 2019 | ANDA211494 | Clobetasol propionate CLOBETASOL PROPIONATE | Saptalis Pharms |
| August 19, 2019 | ANDA209051 | Tafluprost TAFLUPROST | Micro Labs |
| August 9, 2019 | ANDA211954 | Levetiracetam LEVETIRACETAM | Micro Labs |
| August 1, 2019 | ANDA212172 | Methenamine hippurate METHENAMINE HIPPURATE | Micro Labs |
| April 5, 2019 | ANDA203410 | Ketorolac tromethamine KETOROLAC TROMETHAMINE | Micro Labs Ltd India |
| March 29, 2019 | ANDA207004 | Rasagiline RASAGILINE MESYLATE | Micro Labs |
| March 22, 2019 | ANDA208180 | Roflumilast ROFLUMILAST | Micro Labs |
| March 11, 2019 | ANDA210158 | Dalfampridine DALFAMPRIDINE | Micro Labs |
| January 30, 2019 | ANDA211711 | Clobazam CLOBAZAM | Micro Labs |
| December 28, 2018 | ANDA211370 | Verapamil hydrochloride VERAPAMIL HYDROCHLORIDE | Micro Labs |
| November 5, 2018 | ANDA207402 | Clindamycin CLINDAMYCIN HYDROCHLORIDE | Micro Labs |
| October 5, 2018 | ANDA207438 | Methazolamide METHAZOLAMIDE | Bausch and Lomb Inc |
| August 22, 2018 | ANDA205723 | Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE | Micro Labs |
| April 30, 2018 | ANDA204776 | Celecoxib CELECOXIB | Micro Labs |
| December 29, 2017 | ANDA206152 | Piroxicam PIROXICAM | Micro Labs |
| December 14, 2017 | ANDA207400 | Caffeine citrate CAFFEINE CITRATE | Micro Labs |
| December 8, 2017 | ANDA209352 | Sodium nitroprusside SODIUM NITROPRUSSIDE | Micro Labs |
| November 2, 2017 | ANDA207435 | Amlodipine and olmesartan medoxomil AMLODIPINE AND OLMESARTAN MEDOXOMIL | Micro Labs |
| June 27, 2017 | ANDA206713 | Tranexamic acid TRANEXAMIC ACID | Micro Labs |
| December 30, 2016 | ANDA204755 | Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) AMOXICILLIN AND CLAVULANATE POTASSIUM | Micro Labs Ltd India |
| December 30, 2016 | ANDA205707 | Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) AMOXICILLIN AND CLAVULANATE POTASSIUM | Micro Labs Ltd India |
| September 17, 2013 | ANDA202046 | Levocetirizine dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE | Micro Labs Ltd India |
| April 4, 2013 | ANDA202745 | Cromolyn sodium CROMOLYN SODIUM | Micro Labs Ltd India |
| June 29, 2012 | ANDA091220 | Glimepiride GLIMEPIRIDE | Micro Labs |
| May 22, 2012 | ANDA203080 | Nevirapine NEVIRAPINE | Micro Labs Ltd |
| November 19, 2010 | ANDA090562 | Mefenamic acid MEFENAMIC ACID | Micro Labs |
| December 13, 2006 | ANDA040672 | Triamcinolone acetonide TRIAMCINOLONE ACETONIDE | Micro Labs |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2026
-
July 22, 2026 · Class II · Ongoing · D-0730-2026 · Dorzolamide hydrochloride and timolol maleate
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. NDC 42571-147-26.
2024
-
February 12, 2024 · Class II · Ongoing · D-0348-2024 · Clobazam
CGMP Deviations: Out of specification for residual solvents.
Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01
2014
-
October 9, 2014 · Class II · Terminated · D-0046-2015 · Glimepiride
Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA, Inc., Pri
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).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026