Park Avenue Compounding recalls Phenylephrine HCI 1000 mcg / 10 mL syringes over manufacturing practice problems
The notice says the recalled Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL total volume (NDC 83863-0104-1), was made with deviations from current good manufacturing practice (CGMP), and 858 syringes went to Missouri.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall 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.
- Company
- Park Avenue Compounding
- Hazard
- CGMP Deviations
- Units
- 858 syringes
- Where sold
- MO
- FDA classification
- Class II · Ongoing
- Classified by FDA
- December 2, 2025
- Recall started
- September 17, 2025
- FDA enforcement report
- December 10, 2025
- Identifiers
- Codes: Lot # 20250813-13D65E, Exp Date: FEB-09-2026.
- FDA recall number: D-0200-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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.
- Reason for recall
- CGMP Deviations
- Classification
- Class II (Ongoing)
- Distribution
- MO
- Quantity
- 858 syringes
Related recalls
Park Avenue Compounding recalls fentanyl citrate and ropivacaine bags over manufacturing quality rule deviations
The notice says the 150 mL bags of fentanyl citrate 2 mcg / ml and ropivacaine 0.2% in NS were made with deviations from current good manufacturing practice, tied to a revised reading of quality level results.
Park Avenue Compounding · 189 bags
Greenwich Rx recalls Glutathione Injection 10 mL vials over microbial contamination
The notice says the sterile Glutathione Injection (200 mg/mL, 10 mL multi-dose vial, Subcutaneous Only) has microbial contamination, and 4,319 vials were sent across the US.
Greenwich Rx · 4,319 vials
Pritam International recalls Brush Buddies and evo toothpastes over manufacturing practice problems
The notice says these anticavity fluoride toothpastes were made with deviations from current good manufacturing practices and were distributed across the US.
Pritam International Private Limited · 3,309,696 units
Strides Pharma recalls Cinacalcet Tablets 30 mg because they failed dissolution specifications
The 30 mg Cinacalcet Tablets in 30-count bottles failed dissolution specifications, and 49,488 bottles were distributed across the US.
Strides Pharma INC · 49,488 30-count bottles
Viatris recalls telmisartan and amlodipine tablets because telmisartan content may be too high
The tablets may contain more telmisartan than they are supposed to, so the content in these lots could go over the limit set for the product.
Viatris, Inc. · 21,620 30-count bottles
Pfizer recalls Levoxyl 175 mcg levothyroxine sodium tablets over weaker-than-labeled strength
The tablets are subpotent, meaning they are weaker than labeled, after a stability test confirmed an out-of-specification assay result.
Pfizer · 15,949 units