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Lower risk Drug recall · FDA · Published November 29, 2021

Preferred Pharmaceuticals Diclofenac Topical Solution Recall: Leaking Bottles

Preferred Pharmaceuticals recalls 150mL Diclo: Leaking bottles risk contamination. Rx-only product with NDC 68788-7707-01. Stop using if leaking.

🇺🇸 FDA recall #D-0278-2022DrugPreferred Pharmaceuticals ›
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Contact the company

Recalling firmPreferred Pharmaceuticals, Inc.1250 N Lakeview Ave Ste O · Anaheim, CA 92807-1801
✎ GovInfoNow plain-language explainer

Preferred Pharmaceuticals is recalling 150mL Diclofenac Sodium Topical Solution bottles that may leak due to container defects. This poses a risk of contamination if the product leaks, especially since it's a prescription medication. Read more at govinfonow.com/recall/35506-preferred-pharmaceuticals-diclofenac-topical-solution-recall-leaking-bottles.

Source Summary by GovInfoNow · govinfonow.com/recall/35506-preferred-pharmaceuticals-diclofenac-topical-solution-recall-leaking-bottles · Updated August 18, 2026 · FDA enforcement record: FDA #D-0278-2022

Cite this page

“Preferred Pharmaceuticals Diclofenac Topical Solution Recall: Leaking Bottles.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35506-preferred-pharmaceuticals-diclofenac-topical-solution-recall-leaking-bottles. Based on FDA recall #D-0278-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0278-2022%22&limit=1).

The FDA announced on November 29, 2021, that Preferred Pharmaceuticals, Inc. is recalling Diclofenac Sodium Topical Solution due to defective containers that may leak. The recall involves 72 bottles distributed to physician consignees in Connecticut, Florida, and Kansas.

How to tell if you have it

  • Brand: Preferred Pharmaceuticals
  • Product: Diclofenac Sodium Topical Solution, 1.5% w/w
  • NDC: 68788-7707-01
  • Lot #: E1220B
  • Package: 150 mL bottles
  • Quantity: 72 bottles

The hazard

According to the FDA, the product has a defective container that is out of specification for container integrity, leading to bottles leaking.

Context

GovInfoNow's records show Preferred Pharmaceuticals, Inc. has had 32 other recalls on record since August 15, 2018. Other recent recalls of similar products include Sun Pharmaceutical Diclofenac Gel Recall (January 27, 2026), Cipla Diclofenac Gel Recall (December 22, 2025), and Sun Pharmaceutical Fluocinolone Acetonide Solution Recall (December 30, 2025).

How to tell if you have this one

Check for 150mL bottles labeled 'Diclofenac Sodium Topical Solution, 1.5% w/w' with NDC 68788-7707-01. The product was manufactured by SOLA Pharmaceuticals under Preferred Pharmaceuticals, Inc.

  • Brand
    Preferred Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check for Leaks

    Inspect the bottle for signs of leakage. If leaking, stop using it immediately.

Where it went and when

Where it was distributed

Distributed in 3 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: yesCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: yesKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: yesFL

FDA distribution: “Distributed to 5 physician consignees located in the following states: CT, FL, and KS.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Connecticut, Florida, Kansas.

Recall timeline

FDA published this recall 23 days after the firm started it.

1. Firm started the recall: Nov 29, 202112. FDA classified it Class II: Dec 13, 202123. Published in FDA’s Enforcement Report: Dec 22, 202132021
  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.

✎ GovInfoNow

Questions people ask

Is this product safe to use if it doesn't leak?

Yes, if the bottle doesn't leak, it should be safe to use as intended.

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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-0278-2022 (November 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0278-2022 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