CLASS I Drug recall · Reported 1 Jun 2022 · FDA Enforcement Report
Benzonatate capsules, 100mg recalled by Calvin Scott & Company
Calvin Scott is recalling Benzonatate capsules, 100mg, distributed in Georgia. The recall was initiated on 15 Jan 2021 and the FDA has classified it as Class I.
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-1124-2022
- FDA event ID
- 90183
- Recalling firm
- Calvin Scott, Albuquerque, NM
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 15 Jan 2021
- FDA classified
- 9 Jun 2022
- Reported
- 1 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
Timeline
| 15 Jan 2021 | Recall initiated by company | |
| 1 Jun 2022 | Published in enforcement report | +502 days |
| 9 Jun 2022 | Classified by FDA | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
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, 100mg, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 67877-0573-05
Where it was distributed
1 physician in Alpharetta, GA
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
CSI Lot: CS-20180W-004, Exp 3/22
Where was it sold?
1 physician in Alpharetta, GA
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
Other products in this recall event
1 other product · FDA event 90183| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Benzphetamine tablets, 50mg, CIII recalled by Calvin Scott & Company | Calvin Scott | Packaging Defects | GA |
More recalls from Calvin Scott
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Benzphetamine tablets, 50mg, CIII recalled by Calvin Scott & Company | Calvin Scott | Packaging Defects | GA |
| Drug | CLASS II | Diethylpropion, 75 mg tablets, Rx only recalled | Calvin Scott | Potency & Assay | 5 states |
| Drug | CLASS II | Phentermine, 30 mg capsules, Rx only recalled by Calvin Scott & Company | Calvin Scott | Potency & Assay | 5 states |
| Drug | CLASS II | Diethylpropion, 25 mg tablets, Rx only recalled | Calvin Scott | Potency & Assay | 5 states |
| Drug | CLASS II | Topiramate 25mg Tabs White/round tablets recalled | Calvin Scott | Manufacturing (CGMP) Deviations | 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 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 |