CLASS III Drug recall · Reported 15 Jul 2020 · FDA Enforcement Report
Brimonidine Tartrate Opthalmic Solution recalled
Somerset Therapeutics is recalling Brimonidine Tartrate Opthalmic Solution 0.2%, distributed nationwide in the US. The recall was initiated on 4 Jun 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1375-2020
- FDA event ID
- 85826
- Recalling firm
- Somerset Therapeutics, Somerset, NJ
- Brand
- Brimonidine Tartrate
- Manufacturer
- Somerset Therapeutics, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Jun 2020
- FDA classified
- 7 Jul 2020
- Reported
- 15 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 4 Jun 2020 | Recall initiated by company | |
| 7 Jul 2020 | Classified by FDA | +33 days |
| 15 Jul 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Brimonidine 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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Which lots are affected?
Lot #s BRM13W9001, BRM13W9002, BRM13W9003, EXP Dec. 2020: BRM13W9004, EXP Apr. 2021.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 85826This product is part of a recall event; the main page for the event is Brimonidine Tartrate Opthalmic Solution recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Brimonidine Tartrate Opthalmic Solution recalledBrimonidine Tartrate | Somerset Therapeutics | Potency & Assay | Nationwide | |
| CLASS III | Brimonidine Tartrate Opthalmic Solution recalledBrimonidine Tartrate | Somerset Therapeutics | Potency & Assay | Nationwide |
More recalls from Somerset Therapeutics
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dexamethasone Sodium Phosphate Injection, USP, 100 mg recalledDexamethasone Sodium Phosphate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS III | Cisatracurium Besylate Injection USP, 10 mg/* (2mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS III | Cisatracurium Besylate Injection USP, 200mg/*(10mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS III | Cisatracurium Besylate Injection USP, 20 mg/*,(2 mg/mL) recalledCisatracurium Besylate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS III | Atropine Sulfate Ophthalmic Solution recalled by Somerset TherapeuticsAtropine Sulfate | Somerset Therapeutics | Potency & Assay | Nationwide |
Other Brimonidine recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5% recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate Ophthalmic Solution recalled by Apotex | Apotex | Sterility | Nationwide |
| Drug | CLASS III | Brimonidine Tartrate Opthalmic Solution recalledBrimonidine Tartrate | Somerset Therapeutics | Potency & Assay | Nationwide |