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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Glycopyrrolate Injection Recalled for Label Mix-up

Agency Publication Date: June 8, 2023
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Summary

HF Acquisition Co LLC has recalled 9 boxes of Glycopyrrolate Injection (0.2mg/mL, 1mL vials) because the product labels may be incorrect. This medication is an injectable drug typically used in clinical settings to reduce secretions or treat stomach ulcers. No incidents or injuries have been reported, but the manufacturer initiated the recall after discovering the labeling error.

Risk

A label mix-up creates a risk that the wrong medication or an incorrect dosage could be administered to a patient. Because this is an injectable drug, an administration error could result in serious health complications depending on the medication actually contained in the vial.

What You Should Do

  1. This recall affects Glycopyrrolate Injection, USP 0.2mg/mL (1mL vials) manufactured by HF Acquisition Co. LLC with NDC 51662-1487-3.
  2. Check the product packaging for lot numbers 2205095.1 (Expiration Date 7/31/2024) or 2205095. These products were distributed only in Texas, Arizona, and California.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Glycopyrrolate Injection, USP 0.2mg/mL (1mL vial)
Variants: 0.2mg/mL, 1mL vial
Lot Numbers:
2205095.1 (Exp 7/31/2024)
2205095
NDC:
51662-1487-3

Distributed in boxes of 25 vials.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92468
Status: Resolved
Manufacturer: HF Acquisition Co LLC
Sold By: Medical distributors; Wholesalers
Manufactured In: United States
Units Affected: 9 boxes of 25 vials
Distributed To: Texas, Arizona, California

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.