Atropine Sulfate Ophthalmic Solution — Class III drug recall D-0169-2025
Terminated recall by SOMERSET THERAPEUTICS LLC, reported 2025-01-08, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0169-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SOMERSET THERAPEUTICS LLC, Somerset, NJ, United States |
| Recall initiated | 2024-12-16 |
| Classified | 2024-12-31 |
| Reported by FDA | 2025-01-08 |
| Terminated | 2025-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 5,870 bottles |
| Reason classes | specification failure |
| NDC | 70069-0716, 70069-0716-01 |
| Lot numbers | A240211 |
| Expiration dates | 2026-04-20 |
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 for recall
Failed Impurities/Degradation Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0169-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.