Park Avenue Compounding Phenylephrine HCI Recall: CGMP Deviations

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Recalling firmPark Avenue Compounding3662 Park Ave Ste 140 · Saint Louis, MO 63110-2512

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Park Avenue Compounding is recalling phenylephrine HCI 1000 mcg/10mL (Rx only) because of CGMP deviations. This means the product may not meet quality standards and could be unsafe for medical use.

Why it’s dangerous

CGMP deviations indicate potential quality control issues in manufacturing. This could result in the product not meeting safety and purity standards required for medical use. However, the exact risk level is not specified in the recall notice.

Who’s affected

Prescription patients using this specific medication. Healthcare providers who dispensed the product may also be affected.

How to tell if you have this one

Check for NDC code 83863-0104-1 and lot number 20250813-13D65E. The product is a prescription-only phenylephrine HCI solution with 1000 mcg per 10mL.

Brand
Park Avenue Compounding
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the NDC code and lot number to confirm if your product is affected.

✎ GovInfoNow

Questions people ask

Is there a remedy for this recall?

The recall notice does not specify any remedy.

What is the specific product being recalled?

Phenylephrine HCI 1000 mcg/10mL (Rx only) with NDC 83863-0104-1 and lot #20250813-13D65E.

Why was this product recalled?

Due to CGMP deviations, which may indicate quality control issues in manufacturing.

Take action

Contact Park Avenue Compounding

We’ve drafted a message you can send Park Avenue Compounding to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0200-2026 — Park Avenue Compounding Park Avenue Compounding

Hello,

I own a Park Avenue Compounding that is covered by recall D-0200-2026 from Park Avenue Compounding.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0200-2026 (September 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0200-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Park Avenue Compounding recalls Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis,

Recall notice