American Health Packaging Recalls Benzonatate Capsules Due to Wet Capsule Reports
American Health Packaging is recalling 2,284 cartons of Benzonatate Capsules, USP, 100 mg, due to reports of wet capsules.
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: The recall is classified as FDA Class II and involves a manufacturing defect (wet capsules) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
American Health Packaging is voluntarily recalling 2,284 cartons of Benzonatate Capsules, USP, 100 mg. The recall was initiated by the manufacturer following reports of wet capsules, which constitutes a failure of tablet/capsule specifications.
The affected product is identified by AHP lot number 145513 with an expiration date of 6/2016. The product is distributed nationwide and is available in cartons containing 100 individual unit doses. The specific NDC numbers for the affected product are 68084-214-01 (carton) and 68084-214-11 (individual dose).
Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product is found, it should be returned to the pharmacy or distributor for a refund. Patients should consult their healthcare provider for alternative treatment options if they have been prescribed this medication.
The recalled product
- Product
- BENZONATATE (BENZONATATE)
- Brand
- BENZONATATE
- Manufacturer
- American Health Packaging
- 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 (2)
- AHP lot number 145513
- exp 6/2016
Distribution
Distributed nationwide across the United States.
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