CLASS III ONGOING Drug recall · Reported 31 Jan 2024 · FDA Enforcement Report
Benzonatate Capsules, USP, 100 mg x dose cards) recalled
Amerisource Health Services is recalling Benzonatate Capsules, USP, 100 mg x dose cards), distributed nationwide in the US. The recall was initiated on 26 Dec 2023 and the FDA has classified it as Class III.
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-0257-2024
- FDA event ID
- 93778
- Recalling firm
- Amerisource Health Services, Columbus, OH
- Brand
- Benzonatate
- Manufacturer
- American Health Packaging
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 26 Dec 2023
- FDA classified
- 19 Jan 2024
- Reported
- 31 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 26 Dec 2023 | Recall initiated by company | |
| 19 Jan 2024 | Classified by FDA | +24 days |
| 31 Jan 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent drug: Assay results were slightly above specification at the time zero point.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Superpotent drug: Assay results were slightly above specification at the time zero point.
Which lots are affected?
Lot # 1014208, Exp Mar/31/2025
Where was it sold?
Nationwide in the USA
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Amerisource Health Services
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | Nationwide |
Other Benzonatate recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 American Health PackagingBenzonatate | American Health Packaging | Packaging Defects | 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 |