Class II U.S. Food and Drug Administration

Allies Group Inc. THE ONE SPF 50 Invisible Sunscreen GEL, , 3ml - 0.1 fl. oz recall: Subpotent Product: Firm Testing indicated the affected product

Recall published last month

Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

The hazard: Potency, impurity or stability failure

An out-of-specification result prompted this notice — potency, an impurity, or stability over the shelf life.

What the notice says: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

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-0824-2026
Published
September 9, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Allies Group Inc.
Product type
Prescription & OTC drugs
Units affected
27,492 3mL Sachets
Distribution
Nationwide
Made in
United States
Lot / code info
Lots: C13W01A, Exp. 3/27/2027; G23W01A, Exp. 7/24/2027; M04W01, Exp. 12/10/2028.
UPC codes
8885014073293

Products covered by this recall

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.UPC 8 885014 073293

Check your product

The notice names 14 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 8885014073293

Lot or batch code

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

  • C13W01A
  • Exp. 3
  • 27
  • 2027

Best-by / use-by date

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

  • 27
  • 2027
  • 24
  • 12
  • 10
  • 2028. — 27
  • 492 3mL Sachets

Package size

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

  • 3 ml
  • 0.1 fl. oz

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

Allies Group Inc. — An out-of-specification result prompted this notice — potency, an impurity, or stability over the shelf life.

  1. Check the lot number on your pack against the codes listed above before you do anything else.
  2. Report any change in how the medicine is working to FDA MedWatch, which is where most of these signals originate.
  3. Do not stop a prescription on your own. For most conditions an uncertain dose is safer than no dose while you get advice.
  4. Call your prescriber or pharmacist and ask whether to swap the lot, re-test, or change nothing.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Allies Group Inc. — 1209 N Orange St, Wilmington, DE, 19801-1120

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 Allies Group Inc. prescription & otc drugs recalled?

Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label. Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 8885014073293; lot code C13W01A, Exp. 3, 27; best-by date 27 or 2027. 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?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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