Class II U.S. Food and Drug Administration

Pritam International Private Limited evo, Sensitive recall: CGMP Deviations

Recall published 5 days ago

CGMP Deviations.

The hazard: Labelling or manufacturing-practice failure

This recall is about what the packaging says rather than what is in it — which still matters, because the label is how a dose gets chosen.

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-0060-2027
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
389,880 tubes
Distribution
Nationwide
Made in
India
Lot / code info
Lot# LWP250038760606, Exp Date: 08/05/2027; Lot# LWP250045152409B, Exp Date: 10/07/2027; Lot# LWP250046862110B, Exp Date: 11/15/2027; Lot# LWP250047640511C, Exp Date: 12/15/2027; Lot# LWP250051172312B, Exp Date: 01/27/2028; Lot# LWP260052241401A, Exp Date: 03/20/2028; Lot# LWP260055532003, Exp Date: 04/12/2028.
UPC codes
810147886203, 250038760606, 250045152409, 250046862110, 250047640511, 250051172312, 260052241401, 260055532003

Products covered by this recall

evo, Sensitive, Anticavity Fluoride Toothpaste, (potassium nitrate 5%, sodium fluoride 0.24%) Sweet Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-620-35, Item # 88620 UPC8 10147 88620 3

Check your product

The notice names 24 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.

  • 810147886203
  • 250038760606
  • 250045152409
  • 250046862110
  • 250047640511
  • 250051172312
  • 260052241401
  • 260055532003

Lot or batch code

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

  • LWP250038760606
  • LWP250045152409B
  • LWP250046862110B
  • LWP250047640511C
  • LWP250051172312B
  • LWP260052241401A
  • LWP260055532003

Best-by / use-by date

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

  • 08/05/2027
  • 10/07/2027
  • 11/15/2027
  • 12/15/2027
  • 01/27/2028
  • 03/20/2028
  • 04/12/2028

NDC number

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

  • 84140-620-35

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 — This recall is about what the packaging says rather than what is in it — which still matters, because the label is how a dose gets chosen.

  1. Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.
  2. If what you were dispensed does not match your prescription, call the pharmacy before taking another dose.
  3. Keep taking the medicine as prescribed unless the notice or your prescriber says otherwise.
  4. Return the affected pack to the pharmacy for a replacement from a good lot.

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: 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 810147886203, 250038760606, 250045152409; lot code LWP250038760606, LWP250045152409B, LWP250046862110B; best-by date 08/05/2027 or 10/07/2027. 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?

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?

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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