Atropine Sulfate Ophthalmic Solution recall
FDA recall D-0169-2025 · initiated Dec 16, 2024
SOMERSET THERAPEUTICS LLC recalled Atropine Sulfate Ophthalmic Solution in Dec 2024 — an FDA Class III recall (D-0169-2025) because Failed Impurities/Degradation Specifications.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Impurities/Degradation Specifications
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 5,870 bottles
Details
- Product
- Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01
- Recalling company
- Somerset Therapeutics, LLC
- Classification
- Class III
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Dec 16, 2024
- FDA report date
- Jan 8, 2025
This recall is linked to a product we cover: Atropine Sulfate →
Frequently asked
- Was Atropine Sulfate Ophthalmic Solution recalled?
- SOMERSET THERAPEUTICS LLC recalled Atropine Sulfate Ophthalmic Solution in Dec 2024 — an FDA Class III recall (D-0169-2025) because Failed Impurities/Degradation Specifications. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Atropine Sulfate Ophthalmic Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0169-2025 was: Failed Impurities/Degradation Specifications
- Is a recalled Atropine Sulfate Ophthalmic Solution dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Atropine Sulfate Ophthalmic Solution are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: A240211, Exp. Date April 2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0169-2025.