SUN PHARMACEUTICAL INDUSTRIES INC recalls Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ
Sun Pharmaceutical recalls 2mg Tiagabine tablets due to failed impurities testing. This may affect safety but does not cause immediate harm. Check NDC 62756-2:200-83 for affected lots.
Lower-risk recall
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Contact the company & request your remedy
What happened, in plain English
Sun Pharmaceutical is recalling 2mg Tiagabine Hydrochloride tablets because impurities were found during testing. This could pose a safety risk, but the recall does not indicate immediate harm to users. Read more at govinfonow.com/recall/33382-sun-pharmaceutical-tiagabine-tablets-recall-failed-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/33382-sun-pharmaceutical-tiagabine-tablets-recall-failed-impurities-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0914-2023
Cite this page
“Sun Pharmaceutical Tiagabine Tablets Recall: Failed Impurities Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/33382-sun-pharmaceutical-tiagabine-tablets-recall-failed-impurities-risk. Based on FDA recall #D-0914-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0914-2023%22&limit=1).
Why it’s dangerous
The testing found impurities in the medication that may not be safe for use. These impurities could affect how the drug works, potentially causing side effects or reducing effectiveness.
Who’s affected
People who purchased the 2mg Tiagabine Hydrochloride tablets from Sun Pharmaceutical in the US. Those with seizure disorders are most at risk due to potential impurities.
How to tell if you have this one
Check for the NDC number 62756-200-83 on the bottle. The lot number HAC3339A and expiration date of July 2023 are also on the packaging.
- Brand
Sun Pharmaceutical- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC number 62756-200-83 and lot number HAC3339A on the bottle.
Questions people ask
Is this recall dangerous?
The recall is for failed impurities testing, which could affect safety but does not indicate immediate harm.
How do I know if I have the recalled product?
Check for the NDC number 62756-200-83 and lot number HAC3339A on the bottle.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact Sun Pharmaceutical for guidance.
Contact Sun Pharmaceutical
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0914-2023 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0914-2023 from Sun Pharmaceutical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0914-2023 (July 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0914-2023 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.