Use caution Drug recall · FDA · Published May 18, 2022

Strides Pharma Recalls Losartan Potassium Tablets Due to Impurity

Strides Pharma Inc. recalls specific lots of Losartan Potassium Tablets, USP 50 mg due to azido impurity levels exceeding acceptable limits.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0973-2022Drug Strides Pharma ›

Use caution until it’s fixed

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

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Contact the company

Recalling firmStrides Pharma Inc.2 Tower Center Blvd Ste 1102 · East Brunswick, NJ 08816-1100

✎ GovInfoNow plain-language explainer

Strides Pharma Inc. is recalling Losartan Potassium Tablets, USP, 50 mg because manufacturing deviations resulted in azido impurity levels above acceptable limits. The affected products were distributed nationwide and include bottles with NDC 64380-934-05 and NDC 64380-934-08. Consumers should check their medication against the specific lot numbers listed in the recall notice. Read more at govinfonow.com/recall/34683-strides-pharma-recalls-losartan-potassium-tablets-due-to-impurity.

Source Summary by GovInfoNow · govinfonow.com/recall/34683-strides-pharma-recalls-losartan-potassium-tablets-due-to-impurity · Updated October 10, 2026 · FDA enforcement record: FDA #D-0973-2022

Cite this page

“Strides Pharma Recalls Losartan Potassium Tablets Due to Impurity.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/34683-strides-pharma-recalls-losartan-potassium-tablets-due-to-impurity. Based on FDA recall #D-0973-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0973-2022%22&limit=1).

The FDA announced on May 18, 2022, that Strides Pharma Inc. voluntarily recalled Losartan Potassium Tablets, USP, 50 mg due to CGMP deviations involving azido impurity levels above acceptable limits. The agency classified the recall as Class II.

How to tell if you have it

Brand: Strides Pharma
Product: Losartan Potassium Tablets 50 mg
Manufacturer: Vivimed Life Sciences Private Limited
NDC 64380-934-05, Lot 7901146A (Exp Sep-22)
NDC 64380-934-05, Lot 7901147A (Exp Sep-22)
NDC 64380-934-05, Lot 7901148A (Exp Sep-22)
NDC 64380-934-05, Lot 7901149A (Exp Sep-22)
NDC 64380-934-05, Lot 7901279A (Exp Nov-22)
NDC 64380-934-05, Lot 7901280A (Exp Nov-22)
NDC 64380-934-05, Lot 7901281A (Exp Nov-22)
NDC 64380-934-05, Lot 7901282A (Exp Nov-22)
NDC 64380-934-05, Lot 7901283A (Exp Nov-22)
NDC 64380-934-05, Lot 7901284A (Exp Nov-22)
NDC 64380-934-05, Lot 7901359A (Exp Dec-22)
NDC 64380-934-05, Lot 7901360A (Exp Dec-22)
NDC 64380-934-05, Lot 7901361A (Exp Dec-22)
NDC 64380-934-05, Lot 7901362A (Exp Jan-23)
NDC 64380-934-05, Lot 7901406A (Exp Jan-23)
NDC 64380-934-05, Lot 7901407A (Exp Jan-23)
NDC 64380-934-05, Lot 7901408A (Exp Jan-23)
NDC 64380-934-05, Lot 7901409A (Exp Jan-23)
NDC 64380-934-08, Lot 7901008A (Exp Jun-22)
NDC 64380-934-08, Lot 7901009A (Exp Jun-22)
NDC 64380-934-08, Lot 7901150A (Exp Sep-22)
NDC 64380-934-08, Lot 7901151A (Exp Sep-22)
NDC 64380-934-08, Lot 7901285B (Exp Nov-22)
NDC 64380-934-08, Lot 7901286B (Exp Nov-22)
NDC 64380-934-08, Lot 7901287A (Exp Nov-22)
NDC 64380-934-08, Lot 7901288A (Exp Nov-22)
NDC 64380-934-08, Lot 7901289A (Exp Nov-22)
NDC 64380-934-08, Lot 7901290A (Exp Nov-22)
NDC 64380-934-08, Lot 7901291A (Exp Nov-22)
NDC 64380-934-08, Lot 7901292A (Exp Nov-22)
NDC 64380-934-08, Lot 7901293A (Exp Nov-22)
NDC 64380-934-08, Lot 7901294A (Exp Nov-22)

The hazard

The recall addresses CGMP deviations where azido impurity levels were observed to be above acceptable limits. The FDA classified the recall as Class II.

Context

GovInfoNow's records show Strides Pharma Inc. has 9 other recalls on record since May 9, 2017. Other recent recalls of similar products include Taro Recalls Children's Ibuprofen Due to Foreign Substance (March 2, 2026), Unichem Bisoprolol/Hydrochlorothiazide Tablets Recall: N-Nitroso Impurity Risk (Jan. 21, 2026), and Leading Pharma Recalls Furosemide 80mg Due to Impurity (March 20, 2026).

How to tell if you have this one

Look for Losartan Potassium Tablets, USP, 50 mg, Rx Only, distributed by Strides Pharma Inc., East Brunswick, NJ. Check the NDC numbers: 64380-934-05 (90 tablets) or 64380-934-08 (1000 tablets). Verify the lot numbers and expiration dates against the record: Lots 7901146A, 7901147A, 7901148A & 7901149A (Exp Sep-22); Lots 7901279A through 7901284A (Exp Nov-22); Lots 7901359A, 7901360A & 7901361A (Exp Dec-22); Lots 7901362A, 7901406A, 7901407A, 7901408A & 7901409A (Exp Jan-23); Lots 7901008A & 7901009A (Exp Jun-22); Lots 7901150A & 7901151A (Exp Sep-22); and Lots 7901285B, 7901286B, 7901287A, 7901288A, 7901289A, 7901290A, 7901291A, 7901292A, 7901293A & 7901294A (Exp Nov-22).

Brand
Strides Pharma
Category
Drug

FDA recall event · 3 products

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
64380-933-04, 64380-933-05, 64380-933-08, 64380-934-04, 64380-934-05, 64380-934-08, 64380-935-04, 64380-935-05, 64380-935-08

Recall number	Product, codes & lots	Quantity
D-0972-2022	Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-933-05 1000 film coated tablets NDC 64380-933-08; NDC 64380-933-05 Lot 7901007A, Exp Date Jun-22; Lot 7901144A, 7901178A & 7901179A, Exp Date Sep-22; Lots 7901246A & 7901247A, Exp Date Oct-22; Lot 7901343A, Exp Date Dec-22. NDC 64380-933-08 Lot 7901006A, Exp Date Jun-22; Lot 7901145A & 7901180A, Exp Date Sep-22; Lot 7901181A, Exp Date Oct-22.	200407 bottles
D-0973-2022	Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-934-05 1000 film coated tablets NDC 64380-934-08; NDC 64380-934-05 Lot 7901146A, 7901147A, 7901148A & 7901149A, Exp Date Sep-22; Lot 7901279A, 7901280A, 7901281A, 7901282A, 7901283A & 7901284A, Exp Date Nov-22; Lot 7901359A, 7901360A & 7901361A, Exp Date Dec-22; Lot 7901362A, 7901406A, 7901407A, 7901408A & 7901409A, Exp Date Jan-23. 64380-934-08 Lot 7901008A & 7901009A, Exp Date Jun-22; Lot 7901150A & 7901151A, Exp Date Sep-22; Lot 7901285B, 7901286B, 7901287A, 7901288A, 7901289A, 7901290A, 7901291A, 7901292A, 7901293A & 7901294A, Exp Date Nov-22.	381456 bottles
D-0974-2022	Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-935-05 1000 film coated tablets NDC 64380-935-08; 64380-935-05 Lots 7901047B, 7901048B, 7901049B & 7901050B, Exp Date Jul-22; Lots 7901185A, 7901186A, 7901187A & 7901188A, Exp Date Oct-22; Lots 7901250A, 7901251A & 7901252A, Exp Date Nov-22. 64380-935-08 Lots 7900813B, 7900814B, 7900908A, 7900935A, 7900936A, 7900937A, 7900938A & 7900939B, Exp Date May-22; Lots 7901043A, 7901044A, 7901045A & 7901046A, Exp Date Jul-22; Lots 7901158B, 7901159B, 7901160B, 7901161A, 7901182A & 7901183A, Exp Date Sep-22; Lots 7901184A, 7901189A, 7901190A, 7901191A, 7901192A, 7901193A, 7901194A & 7901195A, Exp Date Oct-22; Lots 7901295B, 7901296B, 7901297B, 7901298B, 7901299B, 7901300B, 7901301B & 7901302B, Exp Date Nov-22; Lots 7901338A, 7901339A, 7901340A, 7901341A & 7901342A, Exp Date Dec-22; Lot 7901387A, Exp Date Jan-23	96966 bottles

Based on the official FDA remedy

What to do — step by step

Check Your Medication
Compare your Losartan Potassium Tablets against the NDC numbers and lot numbers listed in the recall description to see if they are affected.
Contact Your Pharmacist
If you have one of the recalled lots, contact your pharmacist or healthcare provider for instructions on how to return the product or obtain a replacement.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

May 18, 2022Firm started the recall
May 28, 2022FDA classified it Class II
Jun 8, 2022Published in FDA’s Enforcement Report
Oct 20, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Other Strides Pharma recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/34683-strides-pharma-recalls-losartan-potassium-tablets-due-to-impurity">Strides Pharma Recalls Losartan Potassium Tablets Due to Impurity (GovInfoNow)</a>

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-0973-2022 (May 18, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0973-2022 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 10, 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.