Lower risk Drug recall · FDA · Published July 29, 2021

Pharmaceutical Associates Ethosuximide Oral Solution Recall: Risk of Senna Syrup Carryover

Pharmaceutical Associates recalls Ethosuximide Oral Solution (250 mg/5 mL) due to potential carryover of Senna Syrup. This prescription medication may cause unintended effects if used without proper cleaning.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0723-2021Drug Pharmaceutical Associates ›

Lower-risk recall

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

Take action

Contact the company

Recalling firmPAI Holdings, LLC. dba Pharmaceutical Associates Inc1700 Perimeter Rd · Greenville, SC 29605-5252

✎ GovInfoNow plain-language explainer

Pharmaceutical Associates is recalling a prescription ethosuximide oral solution because it might contain traces of senna syrup from previous batches. This could lead to unintended medication effects if the product is used without proper cleaning. Read more at govinfonow.com/recall/36004-pharmaceutical-associates-ethosuximide-oral-solution-recall-risk-of-senna-syrup.

Source Summary by GovInfoNow · govinfonow.com/recall/36004-pharmaceutical-associates-ethosuximide-oral-solution-recall-risk-of-senna-syrup · Updated August 18, 2026 · FDA enforcement record: FDA #D-0723-2021

Cite this page

“Pharmaceutical Associates Ethosuximide Oral Solution Recall: Risk of Senna Syrup Carryover.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36004-pharmaceutical-associates-ethosuximide-oral-solution-recall-risk-of-senna-syrup. Based on FDA recall #D-0723-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0723-2021%22&limit=1).

The FDA announced on July 29, 2021, that Pharmaceutical Associates is recalling Ethosuximide Oral Solution due to potential carryover of Senna Syrup. Owners should contact the company for a refund.

How to tell if you have it

Brand: Pharmaceutical Associates
Product: Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL)
NDC: 0121-0670-16
Lot: C9BC
Expiration Date: 31OCT2022
Quantity: 75 cases (6 bottles/case)
Distribution: Nationwide in the USA

The hazard

The recall addresses a lack of current Good Manufacturing Practices (CGMP) and the potential for carryover of Senna Syrup into the Ethosuximide Oral Solution.

Context

GovInfoNow's records show PAI Holdings, LLC. dba Pharmaceutical Associates Inc has issued four other recalls since March 19, 2020. Other recent recalls of similar products include Zydus Icosapent Ethyl Capsules Recall (Dec. 30, 2025), American Regent ACETYLCYSTEINE Solution Recall (July 24, 2026), and SUN PHARMACEUTICAL Clindamycin Phosphate Topical Solution Recall (Nov. 26, 2025).

How to tell if you have this one

Check for the product name 'Ethosuximide Oral Solution USP 250 mg/5 mL', 16 fl oz (473 mL) bottle, and the lot number C9BC expiring October 31, 2022. This product was sold by Pharmaceutical Associates, Inc. in Greenville, SC.

Brand
Pharmaceutical Associates
Category
Drug

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Distributed Nationwide in the USA

Recall number	Product, codes & lots	Quantity	NDC
D-0721-2021	Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605; Lots: a) C98F, C990 Exp. 30SEP2022, C9C2 Exp. 31OCT2022; b) C9E1 Exp. 31OCT2022	a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case)	0121-0868-02, 0121-0868-16, 0121-0868-05, 0121-0868-40, 0121-0868-50, 0121-0868-00
D-0722-2021	Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08; Lot: C62F Exp. 31OCT2022	400 cases (12 bottles/case)	—
D-0723-2021	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; Lot: C9BC Exp. 31OCT2022	75 cases (6 bottles/case)	0121-0670-16

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the lot number C9BC and expiration date of October 31, 2022 on the bottle.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Distributed Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 16 months after the firm started it.

Jul 29, 2021Firm started the recall
Aug 12, 2021FDA classified it Class II
Aug 18, 2021Published in FDA’s Enforcement Report
Dec 2, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/36004-pharmaceutical-associates-ethosuximide-oral-solution-recall-risk-of-senna-syrup">Pharmaceutical Associates Ethosuximide Oral Solution Recall: Risk of Senna Syrup Carryover (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0723-2021 (July 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0723-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.