Benzonatate Capsules Nationwide Recall for Above-Specification Assay Results
Amerisource Health Services is recalling 6,344 cartons of Benzonatate 100 mg capsules nationwide due to assay results that were slightly above specification. No illnesses or injuries have been reported.
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: This is a FDA Class III recall with no reported illnesses or injuries. The potency exceeded specification limits slightly at initial testing but represents a theoretical concern rather than documented harm. Class III recalls are typically rated 1 or 2; above-specification potency without reported adverse events warrants Moderate (2).
Plain-English summary
Amerisource Health Services LLC is recalling 6,344 cartons of Benzonatate Capsules, USP, 100 mg nationwide. Assay results for the recalled lot were found to be slightly above the established specification at the time of initial testing.
Benzonatate is a prescription cough suppressant (antitussive). The affected lot is identified as Lot # 1014208, which expires March 31, 2025, with carton NDC 68084-214-01. The product was distributed nationwide throughout the United States.
The recall was initiated because potency of the affected lot exceeded specification limits at initial assay testing. No illnesses or injuries have been reported in connection with this product.
Patients and healthcare providers who possess the affected lot should verify the lot number on the container. For further information regarding the recall, contact Amerisource Health Services LLC.
The recalled product
- Product
- BENZONATATE (BENZONATATE)
- Brand
- BENZONATATE
- Manufacturer
- Amerisource Health Services LLC
- Affected units
- 6,344
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 # 1014208
- Exp Mar/31/2025
Distribution
Distributed nationwide across the United States.
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FDA (Drugs) · 2015-04-08
- ModerateZydus Recalls Benzonatate Capsules Due to Wet or Leaking Defects
FDA (Drugs) · 2014-12-31
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