Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01

FDA recall notice · announced January 8, 2025 · Somerset Therapeutics

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: A240211, Exp. Date April 2026
Quantity: 5,870 bottles
Status: Terminated
Products in this recall event:
- Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01 (D-0169-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.