The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0169-2025·Announced 2025-01-08

FDA Class III Atropine Sulfate Ophthalmic Solution Recall for Specification Failures

Somerset Therapeutics is recalling Atropine Sulfate Ophthalmic Solution due to failed impurity and degradation specifications. No illnesses have been reported.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class III recall with failed specification tests for impurities and degradation. No illnesses or injuries reported. FDA Class III recalls are typically scored 1 or 2; this is rated 2 because it involves a prescription medication with quality implications, though the source provides no evidence of actual patient harm.

Plain-English summary

Somerset Therapeutics LLC is recalling Atropine Sulfate Ophthalmic Solution, USP 1% (5 mL bottles, Rx only) due to failed impurities and degradation specifications. The affected product is identified by Lot #A240211, with an expiration date of April 2026.

The affected product was distributed nationwide within the United States. Approximately 5,870 bottles were subject to this recall. No illnesses or injuries have been reported in connection with this product.

Healthcare providers and pharmacists who have supplied the recalled product should contact their supplier about obtaining unaffected product. Patients should contact their healthcare provider if they have questions about their medication.

The recalled product

Product
ATROPINE SULFATE (ATROPINE SULFATE MONOHYDRATE)
Brand
ATROPINE SULFATE
Manufacturer
SOMERSET THERAPEUTICS LLC
Category
Drug — Ophthalmic
Hazard
Affected units
5,870

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: A240211
  • Exp. Date April 2026

UPCs (1)

  • 0370069716014

Distribution

Distributed nationwide across the United States.

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