CLASS II Drug recall · Reported 8 Apr 2015 · FDA Enforcement Report
Benzonatate Capsules, USP, 100 mg recalled by American Health Packaging
American Health Packaging is recalling Benzonatate Capsules, USP, 100 mg, distributed nationwide in the US. The recall was initiated on 6 Jan 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0430-2015
- FDA event ID
- 70320
- Recalling firm
- American Health Packaging, Columbus, OH
- Brand
- Benzonatate
- Manufacturer
- American Health Packaging
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jan 2015
- FDA classified
- 1 Apr 2015
- Reported
- 8 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 6 Jan 2015 | Recall initiated by company | |
| 1 Apr 2015 | Classified by FDA | +85 days |
| 8 Apr 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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)
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
Which lots are affected?
AHP lot number 145513, exp 6/2016
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from American Health Packaging
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|---|---|---|---|---|---|
| Drug | CLASS III | Buprenorphine Sublingual Tablets (C-iii), 2 mg recalledBuprenorphine | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS III | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Cyanocobalamin Injection, USP, 1000 mcg per mL recalled | American Health Packaging | Potency & Assay | AL |
| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP 50 mg recalledMetoprolol Succinate | American Health Packaging | Potency & Assay | Nationwide |
Other Benzonatate recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Benzonatate Capsules, USP, 100 mg x dose cards) recalledBenzonatate | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS I | Benzonatate capsules, 100mg recalled by Calvin Scott & Company | Calvin Scott | Packaging Defects | GA |
| Drug | CLASS III | Benzonatate capsules, 200 mg recalled by Strides PharmaBenzonatate | Strides Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Benzonatate Capsules, USP, 100 mg recalled by Zydus Pharmaceuticals USABenzonatate | Zydus Pharmaceuticals USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Benzonatate Capsules, USP, 200 mg recalled by Zydus Pharmaceuticals USA | Zydus Pharmaceuticals USA | Packaging Defects | Nationwide |