CLASS III Drug recall · Reported 14 Jun 2023 · FDA Enforcement Report
Glycopyrrolate Injection, USP 2mg/ML Vial recalled by HF Acquisition Co
HF Acquisition Co is recalling Glycopyrrolate Injection, USP 2mg/ML Vial, distributed in Arizona, California, Texas. The recall was initiated on 6 Jun 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0870-2023
- FDA event ID
- 92468
- Recalling firm
- HF Acquisition Co, Mukilteo, WA
- Brand
- Glycopyrrolate
- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Jun 2023
- FDA classified
- 8 Jun 2023
- Reported
- 14 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Jun 2023 | Recall initiated by company | |
| 8 Jun 2023 | Classified by FDA | +2 days |
| 14 Jun 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-up
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3
Where it was distributed
Distributed in TX, AZ and CA only
Questions about this recall
Is Glycopyrrolate Injection, USP 2mg/ML Vial recalled?
Yes. HF Acquisition Co recalled Glycopyrrolate Injection, USP 2mg/ML Vial on 6 Jun 2023. The recall is Class III and its status is Terminated. Recall number D-0870-2023.
Why was it recalled?
Labeling: Label Mix-up
Which lots are affected?
Lot #: 2205095.1, Exp. Date 7/31/2024
Where was it sold?
Distributed in TX, AZ and CA only
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from HF Acquisition Co
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Sporetraq Mail-in Spore Testing Service, 12 Tests recalled | HF Acquisition Co | Sterility | Nationwide |
| Device | CLASS II | Sporetraq Mail-in Spore Testing Service, 52 Tests recalled | HF Acquisition Co | Sterility | Nationwide |
| Device | CLASS II | Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests recalled | HF Acquisition Co | Sterility | 50 states |
| Device | CLASS II | HealthFirst Emergency Medical Kit recalled by HF Acquisition Co | HF Acquisition Co | Packaging Defects | 39 states |
| Device | CLASS II | STAT KIT Z-1000 emergency medical kit HealthFirst recalled | HF Acquisition Co | Other | Nationwide |
Other Glycopyrrolate recalls
All 28| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Glycopyrrolate Oral Solution, 1 mg/, delivers recalled by Precision DoseGlycopyrrolate | Precision Dose | Potency & Assay | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per 2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS III | Glycopyrrolate Oral Solution, 1 mg recalled by Novadoz PharmaceuticalsGlycopyrrolate | Novadoz Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Glycopyrrolate Tablets, USP, 1 mg recalled by Aurolife PharmaGlycopyrrolate | Aurolife Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 2 mg/mL Single Dose Vial x 25 vials recalledGlycopyrrolate | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |