Advanced Pharma Recalls Esmolol HCl Due to Latex Labeling Defect
Advanced Pharma Inc. is recalling all Esmolol HCl products because the labeling does not indicate that the products may contain synthetic or natural latex.
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 corresponds to a moderate severity score. The hazard is a labeling error regarding latex content, which is a known allergen, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Advanced Pharma Inc. is voluntarily recalling all strengths, dosage forms, and packaging of Esmolol HCl, a prescription-only medication. The recall is being conducted because the product labeling is missing a warning that the products may contain synthetic latex and/or natural latex.
The recall covers all lots within their expiration dates and is distributed nationwide in the United States. The specific hazard is a labeling error where the presence of latex is not disclosed to patients and healthcare providers.
Consumers and healthcare providers should stop using the recalled Esmolol HCl products and contact their healthcare provider or pharmacist for guidance. Patients with known latex allergies should be particularly cautious and consult their medical provider regarding alternative treatments.
The recalled product
- Product
- Esmolol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Cardiovascular
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