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Lower risk Drug recall · FDA · Published August 6, 2024

Dr. Reddy's Ibuprofen Tablets 800mg Rx Only: Impurities May Exceed Safety Limits

Dr. Reddy's recalls 800mg ibuprofen tablets (Rx only) due to impurities exceeding safety limits. Consumers should check NDC codes and expiration dates for affected lots.

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

🇺🇸 FDA recall #D-0644-2024DrugDr. 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 800mg ibuprofen tablets (Rx only) because tests found impurities at levels above the safe limit. This could pose a health risk if taken as directed. Read more at govinfonow.com/recall/32569-dr-reddy-s-ibuprofen-tablets-800mg-rx-only-impurities-may.

Source Summary by GovInfoNow · govinfonow.com/recall/32569-dr-reddy-s-ibuprofen-tablets-800mg-rx-only-impurities-may · Updated September 23, 2026 · FDA enforcement record: FDA #D-0644-2024

Cite this page

“Dr. Reddy's Ibuprofen Tablets 800mg Rx Only: Impurities May Exceed Safety Limits.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32569-dr-reddy-s-ibuprofen-tablets-800mg-rx-only-impurities-may. Based on FDA recall #D-0644-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0644-2024%22&limit=1).

The FDA announced on 2024-08-06 that Dr. Reddy's Laboratories, Inc. is recalling IBU Ibuprofen Tablets, USP, 800 mg due to failed impurity specifications, according to the FDA.

How to tell if you have it

  • Brand: Dr. Reddy's
  • Product: IBU Ibuprofen Tablets, USP, 800 mg, Rx Only
  • NDC 55111-684-01 (100 Tablets per bottle) Lots C2207525, Exp 5/31/2026; C2212902, Exp 11/30/2026
  • NDC 55111-684-05 (500 Tablets per bottle) Lots C2207526, Exp 5/31/2026; C2210751, C2210752, Exp 9/30/2026; C2212765, C2212766, Exp 11/30/2026; C2301027, C2301063, C2301187, C2301188, C2301247, Exp 12/31/2026; C2301356, C2301388, C2301494, C2301478, C2301617, Exp 1/31/2027; C2303381, C2303432, C2303565, C2303630, C2303643, C2303710, Exp 2/28/2027; C2303879, C2303806, C2303895, C2303963, C2304263, C2304264, C2304130, C2304163, C2304427, Exp 3/31/2027
  • Distribution: Nationwide in the USA and Puerto Rico

The hazard

The recall is due to failed impurities and degradation specifications, with results for unknown impurities at 0.13% and 0.11%, exceeding the 0.10% specification limit, according to the FDA.

Context

GovInfoNow's records show Dr. Reddy's Laboratories, Inc. has 85 other recalls on record since 2012-04-09. Other recent recalls of similar products include Dr. Reddy's Varenicline Tablets Recall (2025-11-11), Dr. Reddy's Succinylcholine Chloride Injection Recall (2025-09-26), and Dr. Reddy's Omeprazole Capsules Recall (2025-06-30). Other recent recalls of similar products include Ajanta Pharma Fluphenazine Tablets Recall (2026-08-25), Hikma Ramipril Capsules 10mg Recall (2026-08-24), and Sun Pharmaceutical Fexofenadine 180mg Tablets Recall (2026-06-01).

How to tell if you have this one

Check for NDC codes 55111-684-01 (100 tablets) or 55111-684-05 (500 tablets). Also look for specific expiration dates and lot numbers listed in the recall notice.

  • Brand
    Dr. Reddy's
  • 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
    Ongoing
  • Distribution
    Nationwide in the USA and Puerto Rico
  • NDC
    55111-682-09, 55111-682-01, 55111-682-05, 55111-683-30, 55111-683-50, 55111-683-09, 55111-683-01, 55111-683-05, 55111-684-30, 55111-684-50, 55111-684-60, 55111-684-09, 55111-684-01, 55111-684-05
Recall numberProduct, codes & lotsQuantity
D-0644-2024IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle.; a) NDC 55111-684-01 Lots C2207525, Exp 5/31/2026; C2212902, Exp 11/30/2026. b) NDC 55111-684-05 Lots C2207526, Exp 5/31/2026; C2210751, C2210752, Exp 9/30/2026; C2212765, C2212766, Exp 11/30/2026; C2301027, C2301063, C2301187, C2301188, C2301247, Exp 12/31/2026; C2301356, C2301388, C2301494, C2301478, C2301617, Exp 1/31/2027; C2303381, C2303432, C2303565, C2303630, C2303643, C2303710, Exp 2/28/2027; C2303879, C2303806, C2303895, C2303963, C2304263, C2304264, C2304130, C2304163, C2304427, Exp 3/31/2027.103,298 bottles
D-0645-2024IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5511-683-05 - 500 Tablets per bottle.; a)NDC 55111-683-01 Lots C2207527, Exp 5/31/2026; C2210864, Exp 9/30/2026; C2213018, Exp 11/30/2026. b)NDC 5511-683-05 Lots C2207528, Exp 5/31/2026; C2210860, Exp 9/30/2026; C2213016, C2213017, Exp 11/30/2026; C2301852, C2302056, C2302057, Exp 1/31/2027.31,802 bottles
D-0646-2024IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets per bottle.; a)NDC 55111-682-01 Lots C2207529, Exp 5/31/2026; C2210993, Exp 9/30/2026. b)NDC 55111-682-05 Lots C2207530, Exp 5/31/2026; C2210992, C2210994, Exp 9/30/2026; C2213304, C2213305, Exp 11/30/2026.14940 bottles
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the NDC codes 55111-684-01 or 55111-684-05 on the packaging to confirm if your tablets are affected.

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: yesFLPuerto Rico: yesPR

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

Distributed nationwide.

Recall timeline

FDA published this recall 29 days after the firm started it.

1. Firm started the recall: Aug 6, 202412. FDA classified it Class II: Aug 26, 202423. Published in FDA’s Enforcement Report: Sep 4, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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Other Dr. Reddy's recalls

Dr. Reddy's Laboratories, Inc. recalls Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in
November 11, 2025Dr. Reddy's Laboratories, Inc. recalls Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr.
April 8, 2024

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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-0644-2024 (August 6, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0644-2024 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.
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