Class II U.S. Food and Drug Administration

Sun Pharma /Taro Ciclopirox Shampoo, 1%, 120 mL recall: Failed Impurity/Degradation specifications: OOS results obtained

Recall published 10 months ago

Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint

The hazard: Potency, impurity or stability failure

This is a specification failure: testing showed the product does not match what the label promises.

What the notice says: Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint

Why it matters: The product failed a specification test: it may contain more or less active ingredient than the label states, carry an impurity, or degrade before its expiry date. A sub-potent dose can leave a condition untreated; a super-potent one can cause an overdose.

Symptoms and when to call a doctor

The risk depends entirely on the drug. For a medicine where dose matters closely — a blood thinner, an anti-epileptic, a thyroid or heart medicine, insulin — talk to your prescriber before changing anything. Seek urgent care if you have symptoms that suggest too much drug, or if the condition the medicine controls starts breaking through.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0240-2026
Published
December 24, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Sun Pharma /Taro
Product type
Prescription & OTC drugs
Units affected
17,664 units
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.

Products covered by this recall

Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08

Check your product

The notice names 13 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • AD37059
  • AD37060
  • AD37061
  • AD37062
  • AD37065
  • AD37066
  • AD37067
  • AD37068

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 31
  • 2026. — 17
  • 664 units

NDC number

On the carton and again on the bottle or blister label.

  • 51672-1351-08

Package size

Match the net weight or the piece count on the front of the pack.

  • 120 mL

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Potency

Sun Pharma /Taro — This is a specification failure: testing showed the product does not match what the label promises.

  1. Check the lot number on your pack against the codes listed above before you do anything else.
  2. Call your prescriber or pharmacist and ask whether to swap the lot, re-test, or change nothing.
  3. Keep the carton and the leaflet — the lot number is usually printed only on the outer pack.
  4. Report any change in how the medicine is working to FDA MedWatch, which is where most of these signals originate.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: SUN PHARMA /TARO — 3 Skyline Dr, Hawthorne, NY, 10532-2174

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Sun Pharma /Taro prescription & otc drugs recalled?

Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code AD37059, AD37060, AD37061; best-by date 31 or 2026. — 17. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above before you do anything else.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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