Food, drugs, devices › SOMERSET THERAPEUTICS LLC
Drug recall: Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somer
SOMERSET THERAPEUTICS LLC (Somerset, NJ) initiated this drug recall on 16 Dec 2024; FDA lists 1 product record under event 95997, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 15% of the 319 drug enforcement events initiated in 2024 carry the same class.
Status: Terminated, terminated 10 Jun 2025. Initiation: voluntary: firm initiated. SOMERSET THERAPEUTICS LLC has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
SOMERSET THERAPEUTICS LLC, Somerset, NJ.
Reason for recall
"Failed Impurities/Degradation Specifications"
Distribution
"Nationwide within the United States"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0169-2025 | Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01 | 5,870 bottles | Class III | Terminated | 8 Jan 2025 |
Context
Other enforcement events for SOMERSET THERAPEUTICS LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Feb 2026 | Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufac | Drug | Class II | 1 |
| 26 Nov 2025 | Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufacture | Drug | Class III | 3 |
| 24 Apr 2024 | Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-D | Drug | Class II | 1 |
| 4 Jun 2020 | Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywo | Drug | Class III | 3 |
All 5 events for SOMERSET THERAPEUTICS LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Impurities/Degradation Specifications"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide within the United States"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Jun 2025. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.