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Recalls & Safety AlertsVersion 6

Precision Dose Recalls Lot of Glycopyrrolate Oral Solution Over Unidentified Impurity

An FDA enforcement report dated July 29, 2026 lists the nationwide recall as ongoing and not yet classified.

By AI ReporterUpdated Aug 7, 2026, 11:07 a.m. ET
An FDA enforcement report dated July 29, 2026 lists an recall by of Glycopyrrolate Oral Solution, 1 mg/5 mL, delivering 5 mL, prescription only, packaged in unit-dose oral syringes. The record identifies the product by NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case), and lists Lot # 506033 with an expiration date of 11/30/2026. Packaging is listed as Precision Dose, Inc, S. Beloil, IL 61080. According to the enforcement record, the recall was initiated on July 14, 2026 and the reason given is "an out-of-specification result for an unidentified impurity detected during routine stability testing." The impurity has not been identified in the record. Distribution is listed as US nationwide, and the quantity recalled is listed as not available. The action's status is listed as and its classification as "," meaning the FDA has not yet assigned a hazard classification. No recall number has been assigned in the record. This remains a developing matter. As background, drawn from drug labelling published on DailyMed by the U.S. National Library of Medicine and FDA-approved labelling: glycopyrrolate is a synthetic chemical, a quaternary ammonium salt named 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide, formula C19H28BrNO3, molecular weight 398.33. In this product it is dissolved at 1 mg per 5 mL in a clear, cherry-flavoured watery base whose inactive ingredients are listed as purified water, glycerin, sorbitol solution, propylene glycol, citric acid and sodium citrate, methylparaben and propylparaben, saccharin sodium and cherry flavouring. It is a finished prescription medicine rather than a bulk ingredient: marked "Rx only," it reaches a person through a pharmacy against a prescription or in a hospital or care setting. The base product is normally supplied as a 473 mL (16 fl oz) bottle; the packaging described here is that same solution portioned into single unit-dose syringes each delivering 5 mL, so those holding it are patients, caregivers, pharmacies and facilities rather than manufacturers. This background describes the product generally and says nothing about the recalled lot. The FDA's own enforcement database records no other enforcement action by this firm. That is context only and says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 15:07current

    No new facts in the record; added headline and dek and left the story otherwise unchanged.

  2. Version 57 Aug 2026, 11:59

    Background paragraph tightened and re-attributed to DailyMed/FDA labelling, with the 473 mL bottle format and affected-holder detail added; source links added to citations.

  3. Version 47 Aug 2026, 06:56

    Corrected the chemical name and molecular weight to match DailyMed wording, added the powder's physical description and the FDA unit-dose packaging distinction, and added the source links for the enforcement record and DailyMed labelling.

  4. Version 37 Aug 2026, 02:19

    Product background rewritten to match supplied reference data (DailyMed labelling only; PubChem-sourced description and bulk-distribution claim removed), and firm recall-history line clarified as context only.

  5. Version 26 Aug 2026, 21:17

    Added a sourced description of what glycopyrrolate oral solution is, how it is supplied and who would have it, drawn from DailyMed labelling and PubChem records.

  6. Version 16 Aug 2026, 17:26

    First published.

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