Quick Facts at a Glance
- Recall Date
- September 17, 2025
- Hazard Level
- HIGH
- Brand
- Park Avenue Compounding
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Park Avenue Compounding
- Product type
- Phenylephrine HCI Syringe
- Model numbers
- Lot # 20250813-13D65E, Exp Date: FEB-09-2026.
- Sold at
- Multiple Retailers
- Where affected
- MO
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 17, 2025
Reported by FDA DRUG
December 10, 2025
RecallRadar source check
December 17, 2025
Consumer action
Use the official remedy and keep documentation.
Hazard Information
CGMP Deviations
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Park Avenue Compounding or your healthcare provider for guidance. Notification method: Letter
About This Product
Phenylephrine HCI is a medication commonly used as a decongestant. It is often prescribed for nasal congestion due to colds or allergies.
Why This Is Dangerous
CGMP deviations may indicate that the product was not manufactured under proper regulations, potentially affecting its safety and efficacy.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects a small quantity of syringes, but it poses a high risk due to the potential for improper manufacturing.
Practical Guidance
How to identify if yours is affected
- Check the lot number on your syringes.
- Verify the expiration date which is February 9, 2026.
- Contact your healthcare provider for assistance.
Where to find product info
The lot number can typically be found on the packaging or label of the syringe.
What timeline to expect
Expect a response within a few weeks regarding the recall process.
If the manufacturer is unresponsive
- Keep records of your correspondence with the company.
- Contact the FDA if you do not receive a timely response.
How to prevent similar issues
- Look for CGMP certifications when selecting medical products.
- Consult healthcare providers before using unfamiliar medications.
- Research recalls before using new medications.
Documentation advice
Keep all correspondence, receipts, and labels related to the product for your records.
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Product Details
The recall involves Phenylephrine HCI, 1000 mcg / 10 mL syringes. The product is sold by Park Avenue Compounding, located at 3662 Park Ave, Saint Louis, MO 63110-2512. It falls under the NDC 83863-0104-1.
Key Facts
- Lot # 20250813-13D65E
- Expiration date: FEB-09-2026
- Stop using immediately
- Contact healthcare provider for guidance
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Safety Guide
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