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 routine stability testing found an unidentified impurity at levels outside acceptable specifications. The affected products are identified by NDCs 68094-073-01 and 68094-073-58, distributed across all U.S. states and territories. This is a prescription medication recall.
- 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
- Due to an out-of-specification result for an unidentified impurity detected during routine stability testing.
- 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/39c13947-fabd-4f23-ad73-2c5f34826299