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Unrated Drug recall · FDA · Published March 16, 2022

Dr. Reddy's Atorvastatin Tablets Recall: Impurities May Cause Harm

Dr. Reddy's recalls 80mg Atorvastatin Calcium tablets with impurities that could cause harm. Affected lots from India, expiring 2022-2023. Stop using and contact for details.

🇺🇸 FDA recall #D-0726-2022DrugDr. Reddy's ›
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Recalling firmDr. Reddy's Laboratories, Inc.107 College Rd E · Princeton, NJ 08540-6623
✎ GovInfoNow plain-language explainer

Dr. Reddy's is recalling 80mg Atorvastatin Calcium tablets that failed impurity tests. These tablets could pose health risks if taken as prescribed. Affected products were sold in India with specific lot numbers and expiration dates. Read more at govinfonow.com/recall/35075-dr-reddy-s-atorvastatin-tablets-recall-impurities-may-cause-harm.

Source Summary by GovInfoNow · govinfonow.com/recall/35075-dr-reddy-s-atorvastatin-tablets-recall-impurities-may-cause-harm · Updated August 18, 2026 · FDA enforcement record: FDA #D-0726-2022

Cite this page

“Dr. Reddy's Atorvastatin Tablets Recall: Impurities May Cause Harm.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35075-dr-reddy-s-atorvastatin-tablets-recall-impurities-may-cause-harm. Based on FDA recall #D-0726-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0726-2022%22&limit=1).

The FDA announced on March 16, 2022, that Dr. Reddy's Laboratories, Inc. is recalling Atorvastatin Calcium Tablets, USP 80 mg due to failed impurity specifications. The recall affects 28,068 bottles distributed nationwide.

How to tell if you have it

  • Brand: Dr. Reddy's
  • Product: Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets
  • NDC: 55111-124-90
  • Lots: T000707, T000756, T000758, T000759 (Exp 03/2022); T2100600, T2101075 (Exp. 1/2023); T2102802 (Exp. 07/2023)
  • Quantity: 28,068 bottles

The hazard

The FDA stated the hazard is failed impurities or degradation specifications, specifically out-of-specification results for related substances.

Context

GovInfoNow's records show Dr. Reddy's Laboratories, Inc. has had 85 other recalls on record since April 9, 2012. Other recent recalls of similar products include Dr. Reddy's Varenicline Tablets Recall (Nov. 11, 2025), Dr. Reddy's Succinylcholine Chloride Injection Recall (Sept. 26, 2025), and Dr. Reddy's Omeprazole Capsules Recall (June 30, 2025). Other recent recalls of similar products include Macleods Olanzapine Tablets 5mg Recall (Aug. 27, 2026), SUN PHARMACEUTICAL Clindamycin Phosphate Topical Solution Recall (Nov. 26, 2025), and Sagent Busulfan Injection Recall (May 4, 2026).

How to tell if you have this one

Check for lot numbers T000707, T000756, T000758, T000759 (expiring 03/2022) or T2100600, T2101075 (expiring 01/2023) or T2102802 (expiring 07/2023). The product is sold in India with NDC 55111-124-90.

  • Brand
    Dr. Reddy's
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Lot Number

    Look for lot numbers T000707, T000756, T000758, T000759 (expiring 03/2022), T2100600, T2101075 (expiring 01/2023), or T2102802 (expiring 07/2023) on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

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 terminated this recall 20 months after the firm started it.

1. Firm started the recall: Mar 16, 202212. FDA classified it Class III: Mar 29, 202223. Published in FDA’s Enforcement Report: Apr 6, 202234. FDA terminated the recall: Nov 13, 2023420222023
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-0726-2022 (March 16, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0726-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA