UnratedDrug recall · FDA · Published January 6, 2015
American Health Packaging Recalls Benzonatate Capsules Due to Wetness
American Health Packaging recalls Benzonatate Capsules USP 100 mg due to failed specifications. Check your lot number and expiration date for affected units.
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
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Contact the company
📍Recalling firmAmerican Health Packaging2550 John Glenn Ave, Suite A · Columbus, OH 43217-1188
✎ GovInfoNow plain-language explainer
American Health Packaging is recalling Benzonatate Capsules, USP, 100 mg because some capsules were found to be wet. This failure of tablet/capsule specifications prompted the manufacturer to initiate the recall. The product was distributed nationwide in cartons containing 100 individual unit doses. Read more at govinfonow.com/recall/45030-american-health-packaging-recalls-benzonatate-capsules-usp-100-mg-100.
“American Health Packaging Recalls Benzonatate Capsules Due to Wetness.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/45030-american-health-packaging-recalls-benzonatate-capsules-usp-100-mg-100. Based on FDA recall #D-0430-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0430-2015%22&limit=1).
The FDA announced on Jan. 6, 2015, that American Health Packaging voluntarily recalled Benzonatate Capsules, USP, 100 mg due to failed specifications resulting in wet capsules. The agency classified the recall as Class II.
How to tell if you have it
Brand: American Health Packaging
Product: Benzonatate Capsules 100 mg
NDC 68084-214-01 (carton)
NDC 68084-214-11 (individual dose)
Lot number 145513, exp 6/2016
Quantity: 2284 cartons
The hazard
The recall was initiated because the Benzonatate Capsules failed tablet/capsule specifications, specifically due to reports of wet capsules. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show American Health Packaging has 41 other recalls on record since July 23, 2012. Recent brand recalls include a Buprenorphine Tablets recall for label mix-up hazards on Aug. 19, 2026, and a Nitrofurantoin Capsules recall for dissolution failure risk on May 3, 2022. Other recent recalls of similar products include Keystone Dental City Topical Anesthetic Gel (May 21, 2026), Keystone DHP Topical Anesthetic Gel (May 21, 2026), and Keystone Burkhart Anesthetic Gel (May 21, 2026).
How to tell if you have this one
Look for Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only. Check for NDC 68084-214-01 on the carton or NDC 68084-214-11 on individual doses. Identify lot number 145513 with an expiration date of 6/2016.
Brand
American Health Packaging
Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0430-2015 (January 6, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0430-2015 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.