CLASS II Drug recall · Reported 18 Aug 2021 · FDA Enforcement Report
Ethosuximide Oral Solution USP 250 mg recalled by PAI Holdings
PAI Holdings is recalling Ethosuximide Oral Solution USP 250 mg, distributed nationwide in the US. The recall was initiated on 29 Jul 2021 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-0723-2021
- FDA event ID
- 88392
- Recalling firm
- PAI Holdings, Greenville, SC
- Brand
- Ethosuximide
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jul 2021
- FDA classified
- 12 Aug 2021
- Reported
- 18 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 29 Jul 2021 | Recall initiated by company | |
| 12 Aug 2021 | Classified by FDA | +14 days |
| 18 Aug 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Product as listed by the FDA
Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Is Ethosuximide Oral Solution USP 250 mg recalled?
Yes. PAI Holdings recalled Ethosuximide Oral Solution USP 250 mg on 29 Jul 2021. The recall is Class II and its status is Terminated. Recall number D-0723-2021.
Why was it recalled?
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Which lots are affected?
Lot: C9BC Exp. 31OCT2022
Where was it sold?
Distributed 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 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 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 III | ethosuximide capsules, USP, 250 mg recalled by Pfizer | Pfizer | Other | Nationwide |
| Drug | CLASS III | Zarontin (ethosuximide capsules, USP) 250 mg, Rx Onl,y recalledZarontin | Pfizer | Other | Nationwide |
| Drug | CLASS II | Ethosuximide Capsules, USP, 250 mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |