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Lower risk Drug recall · FDA · Published August 29, 2016

Dr. Red: ZENATANE 20mg Capsules May Not Dissolve Properly

Dr. Reddy's Laboratories recalls ZENATANE (isotretinoin) 20mg capsules due to failed dissolution specifications. This could affect medication effectiveness. Contact for return instructions.

🇺🇸 FDA recall #D-0098-2017DrugDr. Reddy's ›
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Recalling firmDr. Reddy's Laboratories, Inc.107 College Rd E · Princeton, NJ 08540-6623
✎ GovInfoNow plain-language explainer

What happened, in plain English

Dr. Reddy's recalls ZENATANE 20mg capsules because they may not dissolve properly as intended. This could lead to incorrect medication dosing and reduced effectiveness. Read more at govinfonow.com/recall/42464-dr-red-zenatane-20mg-capsules-may-not-dissolve-properly.

Source Summary by GovInfoNow · govinfonow.com/recall/42464-dr-red-zenatane-20mg-capsules-may-not-dissolve-properly · Updated October 9, 2026 · FDA enforcement record: FDA #D-0098-2017

Cite this page

“Dr. Red: ZENATANE 20mg Capsules May Not Dissolve Properly.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42464-dr-red-zenatane-20mg-capsules-may-not-dissolve-properly. Based on FDA recall #D-0098-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0098-2017%22&limit=1).

Why it’s dangerous

The capsules may not dissolve properly in the stomach, leading to inconsistent medication absorption. This could result in incorrect dosing levels and reduced effectiveness of the treatment.

Who’s affected

Prescription users of ZENATANE 20mg capsules who received this specific batch from Dr. Reddy's Laboratories. Those with higher risk of medication errors or specific health conditions may be most affected.

How to tell if you have this one

Check for the product name 'ZENATANE', strength 20mg, and 30 capsules per pack. Look for the lot number 79KB60205 and expiration date 02/18 on the packaging.

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

What to do — step by step

  1. Check Product Details

    Verify the product name, strength, and lot number on the packaging to confirm if it matches the recalled items.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.2 years after the firm started it.

1. Firm started the recall: Aug 29, 201612. FDA classified it Class III: Oct 13, 201623. Published in FDA’s Enforcement Report: Oct 19, 201634. FDA terminated the recall: Nov 8, 2019420162019
  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-0098-2017 (August 29, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0098-2017 to see it in context.
  • Plain-language summary written by qwen3:4b on October 9, 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