Zydus Chlorpromazine 10mg Tablets Recall: Impurity Risk
Zydus Pharmaceuticals recalls 10mg chlorpromazine tablets due to potential impurity levels exceeding safety limits. Affected lots manufactured in India with specific NDC and expiration date.
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
Zydus Pharmaceuticals is recalling 10mg chlorpromazine hydrochloride tablets that may contain an impurity exceeding safe levels. This could pose a health risk if taken by patients. Read more at govinfonow.com/recall/32159-zydus-chlorpromazine-10mg-tablets-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32159-zydus-chlorpromazine-10mg-tablets-recall-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0361-2025
Cite this page
“Zydus Chlorpromazine 10mg Tablets Recall: Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32159-zydus-chlorpromazine-10mg-tablets-recall-impurity-risk. Based on FDA recall #D-0361-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0361-2025%22&limit=1).
Why it’s dangerous
The tablets may contain N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended safety limit. This impurity could potentially cause health issues if the medication is taken as directed.
Who’s affected
Patients prescribed chlorpromazine by a healthcare provider. Those with the specific lot number and NDC 70710-1129-1 are most at risk.
How to tell if you have this one
Check for the product name 'chlorpromazine hydrochloride tablets 10mg', NDC 70710-1129-1, and lot number Z400069. The expiration date is December 31, 2025.
- Brand
Zydus Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Identify the NDC number 70710-1129-1 and lot number Z400069 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 18 states.
FDA distribution: “Nationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, Florida, Indiana, Kentucky, Louisiana, Minnesota, Mississippi, New Jersey, North Dakota, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Vermont, Wisconsin.
Recall timeline
FDA published this recall 13 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-0361-2025 (April 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0361-2025 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.