FDA Drug recall D-0169-2025
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC…
- FDA Drug
- Class III
- terminated
- Published 2025-01-08
On 2025-01-08 the FDA classified a Class III recall of Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC… by Somerset Therapeutics, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0169-2025 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2024-12-16 |
| Published | 2025-01-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Somerset Therapeutics |
| Distribution | US |
Product
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01
Reason
Failed Impurities/Degradation Specifications
Identifiers
| ndc | 70069-716-01 |
|---|---|
| code_info | Lot #: A240211, Exp. Date April 2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0169-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.