Class III · Low risk
Benzonatate Capsules
Superpotent drug: Assay results were slightly above specification at the time zero point.
Is Benzonatate recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Benzonatate (7 total). Check the affected lots below.
Most common reason: Failed specification (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Benzonatate. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Benzonatate recalls on record
none so far in 2026; 7 on record, newest first
Class I · High risk
Benzonatate capsules
Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.
Class III · Low risk
Benzonatate capsules
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Class II · Moderate risk
Benzonatate Capsules
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Class II · Moderate risk
Benzonatate Capsules
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Class II · Moderate risk
Benzonatate Capsules
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Class III · Low risk
BENZONATATE Capsules
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
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