July 2026 FDA Recall Glycopyrrolate by Precision Dose Inc.
N/A - Due to an out-of-specification result for an unidentified impurity detected during routine stability testing.
This Not Yet Classified drug recall was voluntarily initiated by Precision Dose Inc. on July 14, 2026 for the product Glycopyrrolate. The FDA reported the reason for recall as due to an out-of-specification result for an unidentified impurity detected during routine stability testing.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: N/A
Due to an out-of-specification result for an unidentified impurity detected during routine stability testing.
07-14-2026
07-29-2026
N/A
Recall Profile & Regulatory Data
Not Yet Classified
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Precision Dose Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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).
Batch or Lot Expiration Information
Lot# 506033, Exp Date: 11/30/2026.
