← FDA ENFORCEMENT
D-0169-2025Class III

SOMERSET THERAPEUTICS LLC

Recalling firm
SOMERSET THERAPEUTICS LLC
Product type
Drug
Status
Terminated
Report date
2025-01-08
Distribution
Nationwide within the United States
Firm state
NJ
Product quantity
5,870 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Impurities/Degradation Specifications

Product description

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

Code / lot info

Lot #: A240211, Exp. Date April 2026

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.