Phenylephrine HCI recall: CGMP Deviations
Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC…
Why was Phenylephrine HCI recalled?
CGMP Deviations
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 20250813-13D65E, Exp Date: FEB-09-2026.
- Product
- Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC…
- Recalling firm
- Park Avenue Compounding
- Quantity
- 858 syringes
- Distribution
- MO
- Recall date
- December 10, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)