Class II U.S. Food and Drug Administration

Pritam International Private Limited BB Advanced Whitening recall: CGMP Deviations

Recall published 5 days ago

CGMP Deviations.

The hazard: Labelling or manufacturing-practice failure

The defect here is documentary: wrong strength on the label, a mismatched barcode, or records that do not demonstrate the product was made correctly.

What the notice says: CGMP Deviations.

Why it matters: The label, the strength printed on it, the barcode or the manufacturing records do not meet federal requirements. The practical danger is someone taking the wrong drug or the wrong dose while believing they have the right one.

Symptoms and when to call a doctor

If you may have taken a product that turned out to be a different drug or strength from the one on the label, call your prescriber, and call Poison Control on 1-800-222-1222 if you feel unwell. Describe what the pack said and what you actually took.

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-0067-2027
Published
October 28, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Pritam International Private Limited
Product type
Prescription & OTC drugs
Units affected
198,288 tubes
Distribution
Nationwide
Made in
India
Lot / code info
Lot # LWP250036560205A, Exp Date: 05/25/2027; Lot # LWP250038232805A, Exp Date: 06/19/2027; Lot # LWP0054880903D, Exp Date: 01/28/2028; Lot # LWP260056333003C, Exp Date: 06/04/2028.
UPC codes
810147885428, 250036560205, 250038232805, 260056333003

Products covered by this recall

BB (Brush Buddies) Advanced Whitening, Anti-Cavity Fluoride Toothpaste, (sodium fluoride 0,24%) Peppermint, Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-885-42, Item # 88542, UPC 8 10147 88542 8

Check your product

The notice names 15 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.

  • 810147885428
  • 250036560205
  • 250038232805
  • 260056333003

Lot or batch code

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

  • LWP250036560205A
  • LWP250038232805A
  • LWP0054880903D
  • LWP260056333003C

Best-by / use-by date

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

  • 05/25/2027
  • 06/19/2027
  • 01/28/2028
  • 06/04/2028

NDC number

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

  • 84140-885-42

Model or item number

On the rating label, the box or the instruction sheet.

  • 88542

Package size

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

  • 3.5 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 Labelling

Pritam International Private Limited — The defect here is documentary: wrong strength on the label, a mismatched barcode, or records that do not demonstrate the product was made correctly.

  1. Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.
  2. Return the affected pack to the pharmacy for a replacement from a good lot.
  3. Report a mismatch to FDA MedWatch, especially if it reached you rather than being caught at the counter.
  4. If what you were dispensed does not match your prescription, call the pharmacy before taking another dose.

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: PRITAM INTERNATIONAL PRIVATE LIMITED — Khasra No. 138, Raipur Industrial Area, Haridwar

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 Pritam International Private Limited prescription & otc… recalled?

CGMP Deviations. CGMP Deviations.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 810147885428, 250036560205, 250038232805; lot code LWP250036560205A, LWP250038232805A, LWP0054880903D; best-by date 05/25/2027 or 06/19/2027; model number 88542. 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?

Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.

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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