Advanced Pharma Recalls Phenylephrine HCl Due to Latex Labeling Defect
Advanced Pharma Inc. is recalling all lots of Phenylephrine HCl because the product may contain latex but lacks appropriate labeling.
What this means for you
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: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling error regarding latex content, which is a known allergen but does not involve a high-risk pathogen or structural defect.
Plain-English summary
Advanced Pharma Inc. is voluntarily recalling all strengths, dosage forms, and packaging of Phenylephrine HCl. The recall is being conducted because the products may contain synthetic latex and/or natural latex, but the labeling does not properly identify this potential allergen.
The affected products are prescription-only and were distributed nationwide in the United States. The recall covers all lots within their expiration dates. The specific manufacturer of the product is listed as Avella of Houston, Houston, TX 77054.
Patients and healthcare providers should discontinue use of the recalled products and contact their healthcare provider for alternative treatment options. Consumers should check their medication for the specific product name and manufacturer information to determine if they are affected.
The recalled product
- Product
- Phenylephrine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Prescription Medication
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 (1)
- all lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 60 recalled by Advanced Pharma Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 60 products in this recall →Related recalls
Same manufacturer · Advanced Pharma Inc.
See all →- HighAdvanced Pharma Recalls Sub-Potent Hydromorphone Injectable Solution
FDA (Drugs) · 2019-05-08
- SevereAdvanced Pharma Recalls Lidocaine Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- HighAdvanced Pharma Recalls Glycopyrrolate Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- SevereAdvanced Pharma Recalls Heparin Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- SevereAdvanced Pharma Recalls Phenylephrine HCl Injectable Solution Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
Same hazard · latex allergen
See all →- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateHalyard Total Joint Kits Recalled for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits Due to Latex Labeling Error
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOASIS MRI table pads recalled for missing latex allergen labeling
FDA (Devices) · 2021-09-01