Zydus Chlorpromazine Tablets Recall: N-Nitroso Desmethyl Chlorpromazine Risk
Zydus Pharmaceuticals recalls 50mg chlorpromazine tablets due to potential N-Nitroso Desmethyl Chlorpromazine contamination exceeding safety limits. Affected lots from India and US distribution.
Recall notice
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Contact the company
What happened, in plain English
Zydus Pharmaceuticals is recalling 50mg chlorpromazine hydrochloride tablets that may contain unsafe levels of N-Nitroso Desmethyl Chlorpromazine. This chemical could pose health risks if consumed in amounts exceeding the acceptable limit. Read more at govinfonow.com/recall/31805-zydus-chlorpromazine-tablets-recall-n-nitroso-desmethyl-chlorpromazine-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31805-zydus-chlorpromazine-tablets-recall-n-nitroso-desmethyl-chlorpromazine-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0634-2025
Cite this page
“Zydus Chlorpromazine Tablets Recall: N-Nitroso Desmethyl Chlorpromazine Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31805-zydus-chlorpromazine-tablets-recall-n-nitroso-desmethyl-chlorpromazine-risk. Based on FDA recall #D-0634-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0634-2025%22&limit=1).
Why it’s dangerous
The tablets may contain N-Nitroso Desmethyl Chlorpromazine at levels above the recommended safe intake. This chemical is a potential carcinogen that could increase cancer risk with long-term exposure.
Who’s affected
Prescription patients using the recalled 50mg chlorpromazine tablets from Zydus Lifesciences Ltd. in India. Those with specific medical conditions requiring antipsychotic medication may be at higher risk.
How to tell if you have this one
Check for the NDC code 70710-1131-1 on the bottle. The product was manufactured by Zydus Lifesciences Ltd. in India and distributed by Zydus Pharmaceuticals (USA) Inc. in New Jersey.
- Brand
Zydus Pharmaceuticals- Category
Drug
All 10 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
Ongoing- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | NDC |
|---|---|---|
| D-0630-2025 | Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1129-1; Lot #: Z403012, Exp Date 30-04-26; Z406657, Exp Date 30-11-26 | 70710-1129-1, 70710-1129-2, 70710-1129-4, 70710-1130-1, 70710-1130-2, 70710-1130-4, 70710-1131-1, 70710-1131-2, 70710-1131-4, 70710-1132-1, 70710-1132-2, 70710-1132-4, 70710-1133-1, 70710-1133-2, 70710-1133-4 |
| D-0631-2025 | Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-047-01; Lot#: Z403011, Exp Date 30-04-26; Z407335, Exp Date 30-11-26 | 16714-047-01, 16714-048-01, 16714-049-01, 16714-050-01, 16714-051-01 |
| D-0632-2025 | Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1130-1; Lot #: Z305060, Z305061, Exp Date 31-08-25; Z306323, Exp Date 30-11-25; Z401153, Exp Date 28-02-26; Z403015, Z403016, Exp Date 30-04-26; Z405591, Exp Date 30-09-26 | 70710-1129-1, 70710-1129-2, 70710-1129-4, 70710-1130-1, 70710-1130-2, 70710-1130-4, 70710-1131-1, 70710-1131-2, 70710-1131-4, 70710-1132-1, 70710-1132-2, 70710-1132-4, 70710-1133-1, 70710-1133-2, 70710-1133-4 |
| D-0633-2025 | Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-048-01; Lot #: Z305062, exp 31-08-25; Z306324, Exp Date 30-11-25; Z401151, Z401152, Exp Date 28-02-26 | 16714-047-01, 16714-048-01, 16714-049-01, 16714-050-01, 16714-051-01 |
| D-0634-2025 | Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1131-1; Lot #: Z306327, Exp Date 30-11-25; Z306748, Exp Date 30-11-25; Z401154, Exp Date 28-02-26; Z403738, Exp Date 31-05-26; Z405645, Exp Date 30-09-26 | 70710-1129-1, 70710-1129-2, 70710-1129-4, 70710-1130-1, 70710-1130-2, 70710-1130-4, 70710-1131-1, 70710-1131-2, 70710-1131-4, 70710-1132-1, 70710-1132-2, 70710-1132-4, 70710-1133-1, 70710-1133-2, 70710-1133-4 |
| D-0635-2025 | Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-049-01; Lot #: Z306326, Exp Date 30-11-25; Z401155, Exp Date 28-02-26 | 16714-047-01, 16714-048-01, 16714-049-01, 16714-050-01, 16714-051-01 |
| D-0636-2025 | Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1132-1; Lot #: Z305079, Z305080, Exp Date 30-09-25; Z305454, Z305455, Z305457, Z400492, Z400493, Z400494, Exp Date 31-12-25; Z401158, Z401725, Z401726, Exp. Date 28-02-26; Z404118, Z404119, Z404120, Exp Date 30-06-26; Z405648, Exp Date 30-09-26 | 70710-1129-1, 70710-1129-2, 70710-1129-4, 70710-1130-1, 70710-1130-2, 70710-1130-4, 70710-1131-1, 70710-1131-2, 70710-1131-4, 70710-1132-1, 70710-1132-2, 70710-1132-4, 70710-1133-1, 70710-1133-2, 70710-1133-4 |
| D-0637-2025 | Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-050-01; Lot #: Z305456, Exp Date 31-10-25; Z401156, Exp Date 28-02-26; Z407306, Exp Date 30-11-26 | 16714-047-01, 16714-048-01, 16714-049-01, 16714-050-01, 16714-051-01 |
| D-0638-2025 | Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1133-1; Lot #: Z305083, Z305084, Z305468, Z305469, Z305470, Exp Date 30-09-25; Z401163, Z401165, Exp Date 28-02-26; Z402217, Z402218, Exp Date 31-03-26; Z405518, Z405520, Exp Date 31-08-26; Z406235, Exp Date 31-10-26 | 70710-1129-1, 70710-1129-2, 70710-1129-4, 70710-1130-1, 70710-1130-2, 70710-1130-4, 70710-1131-1, 70710-1131-2, 70710-1131-4, 70710-1132-1, 70710-1132-2, 70710-1132-4, 70710-1133-1, 70710-1133-2, 70710-1133-4 |
| D-0639-2025 | Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-051-01; Lot #: Z305085, Exp Date 30-09-25; Z401166, Z401167, Exp Date 28-02-26 | 16714-047-01, 16714-048-01, 16714-049-01, 16714-050-01, 16714-051-01 |
What to do — step by step
Check Product Details
Look for the NDC code 70710-1131-1 on the bottle label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “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 published this recall 14 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.
Similar recalls
Other Zydus Pharmaceuticals recalls
Latest drug recalls
Keep exploring
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-0634-2025 (September 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0634-2025 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.