Atropine Sulfate Ophthalmic Solution recall: Impurity Out of Spec
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC…
Why was Atropine Sulfate Ophthalmic Solution recalled?
Failed Impurities/Degradation Specifications
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: A240211, Exp. Date April 2026
- Product
- Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC…
- Recalling firm
- SOMERSET THERAPEUTICS LLC
- Quantity
- 5,870 bottles
- Distribution
- Nationwide within the United States
- Recall date
- January 8, 2025
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)