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Lower risk Drug recall · FDA · Published June 4, 2020

SomerSET Therapeutics recalls Brimonidine Ophthalmic Solution due to potential impurities

SomerSET Therapeutics recalls Brimonidine Tartrate Ophthalmic Solution 0.2% 10mL bottles (Rx only) manufactured in India with specific lot numbers due to slow leaching from product label affecting product quality over time.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1374-2020DrugSomerSET Therapeutics ›
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Contact the company

Recalling firmSOMERSET THERAPEUTICS LLC300 Franklin Square Dr · Somerset, NJ 08873-4187
✎ GovInfoNow plain-language explainer

SomerSET Therapeutics is recalling Brimonidine Tartrate Ophthalmic Solution 0.2% 10mL bottles (Rx only) because the product label may slowly leach into the solution over time, potentially affecting its quality. This could lead to reduced effectiveness or safety concerns for patients using the medication. Read more at govinfonow.com/recall/37065-somerset-therapeutics-recalls-brimonidine-ophthalmic-solution-due-to-potential-impurities.

Source Summary by GovInfoNow · govinfonow.com/recall/37065-somerset-therapeutics-recalls-brimonidine-ophthalmic-solution-due-to-potential-impurities · Updated October 5, 2026 · FDA enforcement record: FDA #D-1374-2020

Cite this page

“SomerSET Therapeutics recalls Brimonidine Ophthalmic Solution due to potential impurities.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37065-somerset-therapeutics-recalls-brimonidine-ophthalmic-solution-due-to-potential-impurities. Based on FDA recall #D-1374-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1374-2020%22&limit=1).

The FDA announced on June 4, 2020, that Somerset Therapeutics LLC is recalling Brimonidine Tartrate Ophthalmic Solution 0.2% due to failed impurity specifications caused by label leaching. The agency classified the Class III recall as voluntary.

How to tell if you have it

  • Brand: SomerSET Therapeutics
  • Product: Brimonidine Tartrate Ophthalmic Solution 0.2%, 10 mL bottle, Rx only
  • NDC: 70069-232-01
  • Lots: BRM12W9001 (EXP 2020), BRM12W9002 (EXP Dec. 2020), BRM12W9003 (EXP Dec. 2020), BRM12W9004 (EXP Apr. 2021)
  • Quantity: 48,852 bottles
  • Distribution: Nationwide

The hazard

A slow leaching process from the product label on the bottle may impact the product over its shelf life. The recall addresses failed impurities and degradation specifications resulting from this issue.

Context

GovInfoNow's records show Somerset Therapeutics LLC has issued four other recalls since April 24, 2024, including a Dexamethasone Injection recall on Feb. 4, 2026, for failed impurity specifications and a Cisatracurium Besylate Injection recall on Nov. 26, 2025, for subpotent product risk. Other recent recalls of similar products include SUN PHARMACEUTICAL Clindamycin Phosphate Topical Solution Recall (Nov. 26, 2025) and Sun Pharmaceutical Fluocinolone Acetonide Solution Recall (Dec. 30, 2025), both citing impurity risks.

How to tell if you have this one

Check for Brimonidine Tartrate Ophthalmic Solution 0.2% 10mL bottles (Rx only) with lot numbers BRM12W9001, BRM12W9002, BRM12W9003 (expiring Dec. 2020) or BRM12W9004 (expiring Apr. 2021).

  • Brand
    SomerSET Therapeutics
  • Category
    Drug
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class III
  • Status
    Terminated
  • Distribution
    Nationwide
  • NDC
    70069-231-01, 70069-232-01, 70069-233-01
Recall numberProduct, codes & lotsQuantity
D-1373-2020Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-231-01; Lots # BRM11W9001, BRM11W9002, BRM11W9003, EXP Nov 2020; BRM11W9004, BRM11W9005, BRM11W9006, EXP Dec 2020; BRM11W9007, BRM11W9008, BRM11W9009, EXP Mar 2021; BRM11W9010, BRM11W9011, BRM11W9012, BRM11W9013, EXP Apr 2021; BRM11W9014, BRM11W9015, EXP May 2021383,437 bottles
D-1374-2020Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-232-01; Lots # BRM12W9001, EXP 2020; BRM12W9002, BRM12W9003, EXP Dec. 2020; BRM12W9004, EXP Apr. 202148,852 bottles
D-1375-2020Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-233-01; Lot #s BRM13W9001, BRM13W9002, BRM13W9003, EXP Dec. 2020: BRM13W9004, EXP Apr. 2021.22,788 bottles
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for lot numbers BRM12W9001, BRM12W9002, BRM12W9003 (expiring Dec. 2020) or BRM12W9004 (expiring Apr. 2021) on the bottle.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.1 years after the firm started it.

1. Firm started the recall: Jun 4, 202012. FDA classified it Class III: Jul 7, 202023. Published in FDA’s Enforcement Report: Jul 15, 202034. FDA terminated the recall: Jun 30, 2023420202023
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-1374-2020 (June 4, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1374-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA