Benzonatate Capsules (American Health) – Wet Capsules (2015)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 --- NDC 68084-214-01(carton) NDC 68084-214-11 (individual dose)
Brand
American Health Packaging
Lot Codes / Batch Numbers
AHP lot number 145513, exp 6/2016
Products Sold
AHP lot number 145513, exp 6/2016
American Health Packaging is recalling Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American due to Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026