Phenylephrine HCI recall
FDA recall D-0200-2026 · initiated Sep 17, 2025
Park Avenue Compounding recalled Phenylephrine HCI in Sep 2025 — an FDA Class II recall (D-0200-2026) because CGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 858 syringes
Details
- 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 83863-0104-1.
- Recalling company
- Park Avenue Compounding
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- MO
- Initiated
- Sep 17, 2025
- FDA report date
- Dec 10, 2025
Frequently asked
- Was Phenylephrine HCI recalled?
- Park Avenue Compounding recalled Phenylephrine HCI in Sep 2025 — an FDA Class II recall (D-0200-2026) because CGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Phenylephrine HCI recalled?
- Per the FDA enforcement record, the reason for recall D-0200-2026 was: CGMP Deviations
- Is a recalled Phenylephrine HCI dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Phenylephrine HCI are affected?
- Distributed: MO. The recall covers these lots — Lot # 20250813-13D65E, Exp Date: FEB-09-2026.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0200-2026.