Phenylephrine Tropicamide Drops (Isomeric Pharmacy) – sterility issues (2017)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1300, barcode 3 70285 13001 4.
Brand
Isomeric Pharmacy Solution, LLC
Lot Codes / Batch Numbers
Lot Numbers: 10003, Exp 04/05/17, 10018, Exp 04/17/17, 10023, Exp 04/23/17, 10025, Exp 04/24/17, 10027, Exp 04/29/17, 11011, 11012, Exp 05/07/17, 11024, 11026, Exp 05/14/17, 11029, Exp 05/16/17, 11030, Exp 05/17/17, 11032, Exp 05/21/17, 11045, Exp 06/04/17, 12008, Exp 06/13/17, 12014, 12015, Exp 06/20/17, 12022, 12024, Exp 06/28/17, 13001, 13002, Exp 07/03/17, 13011, 13012, Exp 07/09/17.
Products Sold
Lot Numbers: 10003, Exp 04/05/17; 10018, Exp 04/17/17; 10023, Exp 04/23/17; 10025, Exp 04/24/17; 10027, Exp 04/29/17; 11011, 11012, Exp 05/07/17; 11024, 11026, Exp 05/14/17; 11029, Exp 05/16/17; 11030, Exp 05/17/17; 11032, Exp 05/21/17; 11045, Exp 06/04/17; 12008, Exp 06/13/17; 12014, 12015, Exp 06/20/17; 12022, 12024, Exp 06/28/17; 13001, 13002, Exp 07/03/17; 13011, 13012, Exp 07/09/17.
Isomeric Pharmacy Solution, LLC is recalling Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottl due to Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026