Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Bel...

FDA Drug Recall #D-0741-2026 - Class II, July 14, 2026

Recall Summary

Recall Number D-0741-2026
Classification Class II - Moderate risk
Date Initiated July 14, 2026
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Precision Dose Inc.
Location South Beloit, IL
Product Type Drugs
Quantity N/A

Product Description

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 for Recall

Failed Impurities/Degradation Specifications

Distribution Pattern

US Nationwide.

Lot / Code Information

Lot # 506033, Exp Date: 11/30/2026.

Other Recalls from Precision Dose Inc.

Recall # Classification Product Date
D-0095-2022 Class II Acetaminophen Oral Suspension, 325 mg/10.15 mL,... Nov 1, 2021
D-0094-2022 Class II Acetaminophen Oral Suspension, 160 mg/5 mL, pac... Nov 1, 2021
D-0228-2021 Class II Chlorhexidine Gluconate Oral Rinse USP 0.12%, p... Jan 1, 2021
D-1004-2020 Class II Ranitidine Oral Solution, USP, 150 mg/10 mL, [1... Nov 13, 2019
D-0057-2018 Class III Carbamazepine Oral Suspension USP, 100 mg/5 mL,... Sep 25, 2017

Frequently Asked Questions

Nitrosamines are probable human carcinogens, they can increase cancer risk with long-term exposure above certain thresholds, but they do not cause immediate harm from taking a single dose. The FDA calculates an acceptable daily intake (ADI) for each nitrosamine compound, and recalls are triggered when levels exceed this threshold. If you have been taking a recalled product, the FDA generally advises against abruptly stopping your medication (especially for critical conditions like blood pressure or diabetes) until you consult your doctor. The incremental cancer risk from short-term exposure is very small.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications, even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications, use a drug take-back program.