Precision Dose Inc.: Glycopyrrolate Oral Solution, 1 Mg/5 Ml, Delivers

Recall Summary Precision Dose Inc. is recalling Glycopyrrolate Oral Solution (1 mg/5 mL) in unit-dose oral syringes nationwide because the product failed quality testing for impurities and degradation. The affected products have specific lot numbers identified by NDCs 68094-073-01 and 68094-073-58. This recall affects patients across all U.S. states and territories who received this prescription medication.

Recalling firm
Precision Dose Inc.
Product
Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).
Reason
Failed Impurities/Degradation Specifications
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-07-14
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
US Nationwide.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/cc50243e-8e68-4bee-9043-2994997c0fe2