Benzonatate Capsules Recall: Superpotent Drug Hazard
Amerisource Health Services recalls Benzonatate Capsules USP 100 mg due to assay results slightly above specification. Check your lot number.
Use caution until it’s fixed
Superpotent drug: Assay results were slightly above specification at the time zero point.
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What happened, in plain English
Amerisource Health Services LLC is recalling Benzonatate Capsules, USP, 100 mg because the drug content was found to be slightly above the specified limit at the time of testing. This product is distributed by American Health Packaging and affects 6,344 cartons nationwide. The recall was issued on December 26, 2023. Read more at govinfonow.com/recall/32911-benzonatate-capsules-recall-superpotent-drug-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/32911-benzonatate-capsules-recall-superpotent-drug-hazard · Updated October 9, 2026 · FDA enforcement record: FDA #D-0257-2024
Cite this page
“Benzonatate Capsules Recall: Superpotent Drug Hazard.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32911-benzonatate-capsules-recall-superpotent-drug-hazard. Based on FDA recall #D-0257-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0257-2024%22&limit=1).
Why it’s dangerous
The hazard is classified as a 'superpotent drug' issue where assay results were slightly above specification. This means the capsules may contain more active ingredient than labeled, potentially leading to unintended effects from a higher dose during normal use.
Who’s affected
Patients in the USA who have been prescribed or purchased Benzonatate Capsules, USP, 100 mg from this specific distribution batch. Individuals using the affected lot number are at risk of receiving a higher-than-specified dosage.
How to tell if you have this one
Look for Benzonatate Capsules, USP, 100 mg, packaged as 100 capsules (10 capsules x 10 unit dose cards). Check the carton for NDC 68084-214-01, Individual Dose NDC 68084-214-11, Lot # 1014208, and an expiration date of Mar/31/2025.
- Brand
American Health Packaging- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Benzonatate Capsules match the recalled Lot # 1014208 and NDC numbers listed in the record.
Contact Healthcare Provider
Consult your doctor or pharmacist regarding the recall and appropriate next steps for your prescription.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 36 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0257-2024 (December 26, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0257-2024 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.