Compounded phenylephrine syringes recalled over current good manufacturing practice deviations
Park Avenue Compounding is recalling 858 syringes of Phenylephrine HCl, 1000 mcg / 10 mL, over current good manufacturing practice deviations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites current good manufacturing practice deviations with no stated product defect or reported harm.
Plain-English summary
Phenylephrine HCl, 1000 mcg / 10 mL, in a 10 mL total volume syringe, prescription only, from Park Avenue Compounding of Saint Louis, Missouri, under NDC 83863-0104-1, is being recalled.
The reason given in the enforcement record is CGMP deviations.
The recall covers 858 syringes from lot 20250813-13D65E, expiry FEB-09-2026. Distribution was in Missouri. The FDA has classified the action as Class II.
The record cites manufacturing practice deviations without describing a specific product defect, and states no injuries. Facilities should follow the firm's instructions.
The recalled product
- 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.
- Manufacturer
- Park Avenue Compounding
- Category
- Drug — Compounded injectable
- Affected units
- 858
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 20250813-13D65E
- Exp Date: FEB-09-2026.
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Park Avenue Compounding
See all →- ModerateCompounded fentanyl infusion bags recalled over revised quality level interpretation
FDA (Drugs) · 2025-11-26
Same hazard · cgmp deviation
See all →- ModeratePritam International Recalls Brush Buddies Toothpaste Due to CGMP Deviations
FDA (Drugs) · 2026-10-28
- ModerateARU Toothpaste Recalled for CGMP Deviations
FDA (Drugs) · 2026-10-28
- ModeratePritam International Recalls Brush Buddies Fluoride Toothpaste for CGMP Deviations
FDA (Drugs) · 2026-10-28
- ModeratePritam International Recalls Brush Buddies Toothpaste Due to CGMP Deviations
FDA (Drugs) · 2026-10-28
- ModeratePritam International Recalls My Little Pony Toothpaste for CGMP Deviations
FDA (Drugs) · 2026-10-28
Similar recalls
- SevereUS Compounding Recalls Phenylephrine PF Syringes Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- ModerateCompounded fentanyl infusion bags recalled over revised quality level interpretation
FDA (Drugs) · 2025-11-26
- SeverePerry Drug Recalls Phenylephrine Syringes Due to Sterility Concerns
FDA (Drugs) · 2014-12-03
- ModeratePhenylephrine HCl syringe recalled for manufacturing practice deviations
FDA (Drugs) · 2023-03-15
- ModerateFDA Recalls Phenylephrine HCl IV Solution Over Manufacturing Contamination
FDA (Drugs) · 2023-07-26
- SevereUS Compounding Recalls Fentanyl Syringes Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-11-25