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Drug recall · FDA · Published June 22, 2023

ALEMBIC PHARMACEUTICALS, INC. recalls Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic

Alembic recalls 2% diclofenac topical solution bottles with defective delivery system. This may cause injury during use. Check NDC 62332-487-12 and lots 220151-220153.

🇺🇸 FDA recall #D-0941-2023DrugAlembic ›
Take action

Contact the company & request your remedy

Recalling firmALEMBIC PHARMACEUTICALS, INC.550 Hills Dr Ste 104b, N/A · Bedminster, NJ 07921-1537
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

Alembic is recalling diclofenac sodium topical solution bottles that have a defective delivery system. This could lead to injury if the product is used improperly. Read more at govinfonow.com/recall/33405-alembic-diclofenac-topical-solution-recall-defective-delivery-system-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/33405-alembic-diclofenac-topical-solution-recall-defective-delivery-system-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0941-2023

Cite this page

“Alembic Diclofenac Topical Solution Recall: Defective Delivery System Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/33405-alembic-diclofenac-topical-solution-recall-defective-delivery-system-risk. Based on FDA recall #D-0941-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0941-2023%22&limit=1).

Why it’s dangerous

The defective delivery system may cause the product to leak or spill during use, potentially leading to skin irritation or injury. This is a risk during application but not an immediate danger.

Who’s affected

People with prescriptions for diclofenac topical solution who bought the recalled bottles. Those using the product for pain relief are most at risk.

How to tell if you have this one

Check for NDC code 62332-487-12 and production lots 220151, 220152, or 220153. The product is a 3.8 fl.oz. bottle sold by prescription.

  • Brand
    Alembic
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for NDC 62332-487-12 and production lots 220151, 220152, or 220153 on the bottle.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The product may have a defective delivery system that could cause leakage or spillage during use, so it's not safe to use as is.

How do I know if I have the recalled product?

Check for NDC code 62332-487-12 and production lots 220151, 220152, or 220153 on the bottle.

What should I do if I have the recalled product?

The recall record does not specify a remedy, so contact Alembic Pharmaceuticals for guidance.

Take action

Contact Alembic

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

Subject: Recall D-0941-2023 — Alembic Alembic

Hello,

I own a Alembic that is covered by recall D-0941-2023 from Alembic.

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-0941-2023 (June 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0941-2023 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