Glenmark recalls 100mg chlorpromazine tablets due to impurity risk
Glenmark Pharmaceuticals recalls 100mg chlorpromazine hydrochloride tablets (NDC 68462-864-01) with a nitrosated impurity that may pose health risks. Affected lots 17232222 and 17232237 expire 10/31/2025.
Lower-risk recall
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Contact the company
What happened, in plain English
Glenmark is recalling 100mg chlorpromazine hydrochloride tablets that contain a harmful impurity. This impurity could potentially cause health issues if taken by people who need medication. Read more at govinfonow.com/recall/32230-glenmark-recalls-100mg-chlorpromazine-tablets-due-to-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32230-glenmark-recalls-100mg-chlorpromazine-tablets-due-to-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0309-2025
Cite this page
“Glenmark recalls 100mg chlorpromazine tablets due to impurity risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32230-glenmark-recalls-100mg-chlorpromazine-tablets-due-to-impurity-risk. Based on FDA recall #D-0309-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0309-2025%22&limit=1).
Why it’s dangerous
The tablets contain N-Nitroso-Desmethyl Chlorpromazine, an impurity that exceeds safety limits. This impurity could potentially cause health issues if taken by people who need the medication.
Who’s affected
People with a prescription for chlorpromazine hydrochloride tablets who received the recalled lots (17232222 and 17232237) from Glenmark. Those with a prescription for this medication are most at risk.
How to tell if you have this one
Check for the product name 'chlorpromazine hydrochloride tablets, USP 100 mg, Rx Only, 100 Tablets per bottle'. Look for lot numbers 17232222 or 17232237 on the packaging. The expiration date is 10/31/2025.
- Brand
Glenmark- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number on the packaging to see if it matches 17232222 or 17232237.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA and PR” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 29 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-0309-2025 (March 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0309-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.