CLASS III Drug recall · Reported 2 Oct 2019 · FDA Enforcement Report
Zarontin (ethosuximide capsules, USP) 250 mg, Rx Onl,y recalled
Pfizer is recalling Zarontin (ethosuximide capsules, USP) 250 mg, Rx Onl,y, distributed nationwide in the US. The recall was initiated on 12 Sep 2019 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-0002-2020
- FDA event ID
- 83788
- Recalling firm
- Pfizer, New York, NY
- Brand
- Zarontin
- Manufacturer
- Parke-Davis Div of Pfizer Inc
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Sep 2019
- FDA classified
- 1 Oct 2019
- Reported
- 2 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 12 Sep 2019 | Recall initiated by company | |
| 1 Oct 2019 | Classified by FDA | +19 days |
| 2 Oct 2019 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Product as listed by the FDA
Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in Netherlands Distributed by Parke-Davis Division of Pfizer In NY, NY 10017, NDC 0071-0237-24
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Zarontin (ethosuximide capsules, USP) 250 mg, Rx Onl,y recalled?
Yes. Pfizer recalled Zarontin (ethosuximide capsules, USP) 250 mg, Rx Onl,y on 12 Sep 2019. The recall is Class III and its status is Terminated. Recall number D-0002-2020.
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Which lots are affected?
Lot #3267079, Exp 09/2021
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Ethosuximide recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ethosuximide Oral Solution USP 250 mg recalled by PAI HoldingsEthosuximide | PAI Holdings | Manufacturing (CGMP) Deviations | Nationwide |
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