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Drug recall · FDA · Published March 8, 2018

Dr. Reddy's Laboratories, Inc. recalls Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ

Dr. Reddy's recalls 0.1% Clocortolone Pivalate Cream tubes due to stability testing failures. This cream may not be effective or safe after expiration.

🇺🇸 FDA recall #D-0598-2018DrugDr. Reddy's ›
Take action

Contact the company & request your remedy

Recalling firmDr. Reddy's Laboratories, Inc.107 College Rd E · Princeton, NJ 08540-6623
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Dr. Reddy's is recalling 0.1% Clocortolone Pivalate Cream tubes because stability tests showed the product's viscosity was out of specification. This means the cream might not work properly or could be unsafe after the expiration date. Read more at govinfonow.com/recall/40782-dr-reddy-s-clocortolone-pivalate-cream-recall-stability-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/40782-dr-reddy-s-clocortolone-pivalate-cream-recall-stability-issues · Updated October 7, 2026 · FDA enforcement record: FDA #D-0598-2018

Cite this page

“Dr. Reddy's Clocortolone Pivalate Cream Recall: Stability Issues.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40782-dr-reddy-s-clocortolone-pivalate-cream-recall-stability-issues. Based on FDA recall #D-0598-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0598-2018%22&limit=1).

Why it’s dangerous

The cream failed stability testing, meaning its viscosity was outside acceptable limits. This could cause the product to become ineffective or potentially unsafe over time, especially after the expiration date.

Who’s affected

People with a prescription for this cream are affected. Those using it for conditions like skin inflammation may be at risk if the product becomes unstable.

How to tell if you have this one

Check for the 0.1% Clocortolone Pivalate Cream, 90-gram tube labeled with NDC 43598-341-90. It was distributed by Dr. Reddy's Laboratories, Inc. in Princeton, NJ.

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

What to do — step by step

  1. Check Product Label

    Look for the NDC code 43598-341-90 on the tube to confirm it is the recalled product.

✎ GovInfoNow

Questions people ask

Is this cream safe to use?

The recall indicates stability issues, so the cream may not be effective or safe after expiration. Consult your doctor for advice.

How do I know if I have the recalled product?

Check for the NDC code 43598-341-90 on the 90-gram tube labeled with the manufacturer's address in Princeton, NJ.

What should I do if I have this cream?

The recall does not specify a remedy, so contact your doctor or pharmacist for guidance.

Take action

Contact Dr. Reddy's

We’ve drafted a message you can send Dr. Reddy's to request your refund or repair — edit it as you like.

Subject: Recall D-0598-2018 — Dr. Reddy's Dr. Reddy's

Hello,

I own a Dr. Reddy's that is covered by recall D-0598-2018 from Dr. Reddy's.

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-0598-2018 (March 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0598-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on October 7, 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