Heritage Pharmaceuticals, Inc. recalls Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited,
Heritage Pharmaceuticals recalls Losartan Potassium 100mg tablets with impurity NMBA above safe levels. Consumers should check NDC and lot numbers for affected batches.
Recall notice
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Contact the company & request your remedy
What happened, in plain English
Heritage Pharmaceuticals is recalling Losartan Potassium Tablets USP 100mg due to FDA-confirmed impurities in the product. This impurity may pose a health risk if consumed in amounts exceeding the acceptable daily intake level. Read more at govinfonow.com/recall/38845-heritage-pharmaceuticals-losartan-tablets-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38845-heritage-pharmaceuticals-losartan-tablets-recall-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1288-2019
Cite this page
“Heritage Pharmaceuticals Losartan Tablets Recall: Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38845-heritage-pharmaceuticals-losartan-tablets-recall-impurity-risk. Based on FDA recall #D-1288-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1288-2019%22&limit=1).
Why it’s dangerous
The product contains N-Methylnitrosobutyric acid (NMBA) at levels above the interim acceptable daily intake. This impurity could potentially cause health issues if consumed over time, though the exact risk level is not specified in the recall notice.
Who’s affected
People who own or use Losartan Potassium Tablets USP 100mg manufactured by Vivimed Life Sciences in India and distributed by Heritage Pharmaceuticals in the US are affected. Those with hypertension or kidney conditions may be at higher risk due to medication interactions.
How to tell if you have this one
Check for NDC 23155-646-09 and lot numbers CLO17012A through CLO18022A on the packaging. The tablets were manufactured in India and distributed by Heritage Pharmaceuticals in the US.
- Brand
Heritage Pharmaceuticals- Category
Drug
All 5 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
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1287-2019 | Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-645-10; Lot CLO17007A Lot CLO17008A Lot CLO17009A ; Exp 11/2019 | 3012 bottles |
| D-1288-2019 | Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-09; Lot CLO17012A exp 11/2019 Lot CLO17013A exp 11/2019 Lot CLO18002A exp 01/2020 Lot CLO18020A exp 04/2020 Lot CLO18021A exp 04/2020 Lot CLO18022A exp 04/2020 | 25220 bottles |
| D-1289-2019 | Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-645-09; Lot CLO17009B exp 11/2019 Lot CLO17010A exp 11/2019 Lot CLO18023A exp 04/2020 | 34403 bottles |
| D-1290-2019 | Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-10; CLO17014A exp 12/2019 CLO17015A exp 01/2020 CLO17016A exp 01/2020 CLO17017A exp 01/2020 CLO18001A exp 01/2020 CLO18002B exp 01/2020 | 3697 bottles |
| D-1291-2019 | Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-644-09; Lot CLO17006A exp 11/2019 | 15541 bottles |
What to do — step by step
Check Product Details
Look for NDC 23155-646-09 and lot numbers CLO17012A through CLO18022A on the packaging.
Questions people ask
Is this impurity dangerous?
The recall states the impurity is above the interim acceptable daily intake level, but the exact health risk is not specified in the notice.
How can I check if my tablets are affected?
Check the NDC code 23155-646-09 and lot numbers CLO17012A through CLO18022A on the packaging.
What should I do if I have the affected tablets?
The recall does not specify a remedy, so contact Heritage Pharmaceuticals at 1-866-901-DRUG (3784) for guidance.
Contact Heritage Pharmaceuticals
We’ve drafted a message you can send Heritage Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1288-2019 — Heritage Pharmaceuticals Heritage Pharmaceuticals Hello, I own a Heritage Pharmaceuticals that is covered by recall D-1288-2019 from Heritage Pharmaceuticals. 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-1288-2019 (May 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1288-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.