PD-Rx Pharmaceuticals, Inc. recalls Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals,
PD-Rx Pharmaceuticals recalls 50mg Losartan Potassium Tablets due to AZIDO impurity levels exceeding safety limits. Affected lots manufactured in India with specific expiration dates.
Recall notice
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Contact the company & request your remedy
What happened, in plain English
PD-Rx Pharmaceuticals is recalling 50mg Losartan Potassium Tablets because they contain AZIDO impurities at levels above acceptable safety limits. This could pose a health risk to patients taking the medication. Read more at govinfonow.com/recall/34656-pd-rx-losartan-tablets-recall-azido-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/34656-pd-rx-losartan-tablets-recall-azido-impurity-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-1162-2022
Cite this page
“PD-Rx Losartan Tablets Recall: AZIDO Impurity Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/34656-pd-rx-losartan-tablets-recall-azido-impurity-risk. Based on FDA recall #D-1162-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1162-2022%22&limit=1).
Why it’s dangerous
The recall is due to AZIDO impurities found in the medication at levels exceeding regulatory safety limits. While the exact health risk isn't specified in the notice, such impurities can potentially cause health issues when taken by patients.
Who’s affected
Patients prescribed this medication by a healthcare provider are affected. Those using the product without a prescription are not impacted as it's an Rx-only product.
How to tell if you have this one
Check for the product name 'Losartan Potassium Tablets, USP 50 mg, 90 Tablets' with the NDC 72789-164-90. Look for specific lot numbers and expiration dates listed in the recall notice.
- Brand
PD-Rx Pharmaceuticals- Product
Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals- Category
Drug
All 3 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- NDC
72789-163-90, 72789-164-90, 72789-165-90
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1161-2022 | Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-163-90 UPC 3 72789 16390 1; Lots: D21C18 Exp. 09/30/22; E21A28 Exp. 09/30/22; E21C04 Exp. 09/30/22; E21D59 Exp. 09/30/22; G21B65 Exp. 09/30/22; H21A12 Exp. 09/30/22; H21D42 Exp. 09/30/22; K21D19 Exp. 10/31/22; A22A73 Exp. 10/31/22 | 1441 bottles |
| D-1162-2022 | Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-164-90 UPC 3 72789 16490 8; Lots: D21D63 Exp. 11/30/22; E21A73 Exp. 11/30/22; E21D35 Exp. 11/30/22; F21A28 Exp. 11/30/22; F21D04 Exp. 09/30/22; G21B03 Exp. 11/30/22; G21E23 Exp. 11/30/22; H21B46 Exp. 11/30/22; H21D46 Exp. 08/31/23; H21D46 Exp. 08/31/23; I21B67 Exp. 01/31/23; J21A26 Exp. 01/31/23; J21C44 Exp. 01/31/23 | 687 bottles |
| D-1163-2022 | Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-165-90 UPC 3 72789 16590 5; Lots: G21C26 Exp. 07/31/22; H21B96 Exp. 07/31/22; I21B39 Exp. 07/31/22; I21C44 Exp. 07/31/22; D21F35 Exp. 10/31/22; E21A66 Exp. 10/31/22; E21C72 Exp. 10/31/22; E21F01 Exp. 10/31/22; F21C15 Exp. 10/31/22; F21E19 Exp. 10/31/22; G21B14 Exp. 10/31/22; K21A61 Exp. 11/30/22; L21A45 Exp. 11/30/22 | 1320 bottles |
What to do — step by step
Check Product Details
Verify the product name, NDC number, and lot numbers to confirm if your medication is affected.
Questions people ask
Is this medication safe to take?
The recall notice states that AZIDO impurity levels were above acceptable limits, but does not specify the exact health risk. Patients should not take the medication until they confirm it's not affected.
What should I do if I have this medication?
The recall notice does not provide specific action steps for affected products. Check the product details to confirm if it's affected and contact your healthcare provider for guidance.
Are there any specific lot numbers I should avoid?
The recall includes specific lot numbers like D21D63, E21A73, and others with expiration dates through November 2023. Check your product's lot number against the list provided in the recall notice.
Contact PD-Rx Pharmaceuticals
We’ve drafted a message you can send PD-Rx Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1162-2022 — PD-Rx Pharmaceuticals Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed a Hello, I own a Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals that is covered by recall D-1162-2022 from PD-Rx 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-1162-2022 (June 6, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1162-2022 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.
