Independent newsroom

Sunday, October 25, 2026

The File

Every claim traces to a primary source. Uncertainty is labeled. Corrections are public.

Safety · Sunday, October 25, 2026

A Class II recall covers about 4.3 million tubes of toothpaste

The File desk · Oct. 25, 2026, 7:51 a.m. ET

Confirmed2 primary sourcesAdded 7:51 a.m. ET, Oct. 25

Status

Confirmed from the Food and Drug Administration's enforcement-report records for recall event 99849, and from the recall definition in 21 CFR § 7.3(m)(2). The entries say CGMP deviations. They do not say which rule was missed, and they do not say whether anyone got sick.
  • Confirmed
    FDA event 99849. Pritam International Private Limited, of Haridwar, India, began a voluntary recall on Sept. 10, 2026. The agency classified it Class II on Oct. 19. The event record says 4,300,147 pieces, distributed nationwide in the United States. Seventeen lines, D-0053-2027 through D-0069-2027, are marked classification 2.
  • Confirmed
    Under 21 CFR § 7.3(m)(2), Class II means the product may cause a temporary or medically reversible health problem, or the probability of serious harm is remote.
The Food and Drug Administration has classified a recall of about 4.3 million tubes of toothpaste as Class II. Many of the tubes are children's brands. The company that made them started the recall on Sept. 10. The agency put the Class II label on it on Oct. 19. The entries say the problem is a manufacturing-rule failure. They do not say what failed, and they do not say whether anyone got sick.12
The firm is Pritam International Private Limited, in Bhagwanpur, Haridwar, India. The recall is voluntary, firm-initiated, and ongoing. Distribution is listed as nationwide in the United States. Every product line says it is distributed by Ashtel Studios Inc., of Ontario, California. The recall numbers run from D-0053-2027 through D-0069-2027. The brands on the list include Brush Buddies tubes sold as Barbie, Hot Wheels, Crayola Silly Scents, and My Little Pony, plus evo, ARU, and Brush Buddies ice-cream flavors.1
Class II is the middle of three recall classes, and it is defined in 21 CFR § 7.3(m)(2). Use of the product may cause a health problem that is temporary or that medicine can reverse, or the probability of serious harm is remote. Class I is the class where serious harm or death is reasonably probable. Class III is the class where adverse health effects are not likely. The agency's classification code on each of these 17 lines is 2, which is Class II.21
The reason printed on the lines is "CGMP deviations." The letters are the agency's abbreviation for current good manufacturing practice, the rules for how a drug is made. The entries do not say which rule was missed. They have no field for illnesses. They also have no instructions for a refund or a return. A reader who wants to know if a tube is included matches the lot code and the expiration date on the crimp to the FDA list.1
Why it matters (Estimate). The tubes are already in bathrooms, including children's, and some of the lots on the list do not expire until December 2028.1 (Estimate — our reading.) Class II is the agency's way of saying serious harm is a remote chance, or that any harm would be temporary or reversible. It is not a finding that the toothpaste is safe to ignore, and it is not a warning that it will hurt someone. The record does not say what went wrong in the factory, and it does not say that anyone got sick. The check a household can actually do is the lot code and the date on the tube, set next to the FDA list.21
The event record's total is 4,300,147 pieces. Adding the 17 lines comes to 4,301,700. One line is typed "17,400 tupes." The two totals differ by 1,553. Either way the figure is about 4.3 million. The soonest expiration date this desk found on the list is Nov. 30, 2026, on a My Little Pony lot. The latest is Dec. 4, 2028, on a Hot Wheels lot, number LWP250035370104.1
How we know

Notes

  1. 1.FDA enforcement-report records for recall event 99849, read Oct. 25, 2026. Firm: PRITAM INTERNATIONAL PRIVATE LIMITED, Khasra No. 138, Raipur Industrial Area, Bhagwanpur, Haridwar, India. FEI 3020826443. Voluntary: Firm initiated. Phase: Ongoing. Center: CDER. Distribution: "US Nationwide." Recall initiation: September 10, 2026. Center classification date, posted to the internet, report date, and determination date: Oct. 19, 2026. Enforcement-report date on the record: Oct. 28, 2026. Distributed quantity on the event: "4,300,147 pieces." Seventeen product lines, recall numbers D-0053-2027 through D-0069-2027, each with center classification type 2. FDA's classification list maps 2 to Class II, 1 to Class I, 3 to Class III, and NC to Not Yet Classified. Reason on the lines: "CGMP Deviations" or "CGMP Deviations." Each description includes "Distributed by Ashtel Studios Inc., Ontario, California 91761." Quantities include Barbie bubble gum 409,800 tubes (D-0053), Hot Wheels strawberry 411,600 (D-0054), three Crayola Silly Scents lines at 320,232 each (D-0055 through D-0057), My Little Pony "17,400 tupes" (D-0058), evo Advanced Whitening 405,336 (D-0059), evo Sensitive 389,880 (D-0060), four Brush Buddies ice-cream flavors at 112,092 each (D-0061 through D-0064), whitening baking soda 797,868 (D-0065), a Brush Buddies cavity-protection two-pack 231,936 (D-0066), advanced whitening 198,288 (D-0067), and two ARU lines at 15,264 each (D-0068 and D-0069). The line quantities add to 4,301,700. The event total is 4,300,147. Difference: 1,553. Example lots, not the whole list: Barbie LWP250031810502A, expiration 02/28/2027. My Little Pony LWP240022080309, expiration 11/30/2026, the earliest date found. Hot Wheels LWP250035370104, expiration 12/4/2028, the latest date found. The public event address is https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99849 The page is a script. The static page this desk opened did not contain the product text. The figures were read from FDA enforcement-report records for event 99849. openFDA, https://api.fda.gov/drug/enforcement.json , last_updated 2026-10-14. A search for recall_number D-0053-2027 returned no matches. Two typed oddities left as printed: D-0056 has "fluoride0.243%" without a space, and D-0067 has "0,24%" with a comma. The ARU cavity-protection UPC is printed "8 10147 88785" without a check digit.
  2. 2.Electronic Code of Federal Regulations, 21 CFR 7.3, Definitions, retrieved Oct. 25, 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-7/subpart-A/section-7.3 Section 7.3(m)(2): "Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." Section 7.3(m)(1): Class I is a situation in which there is a reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death. Section 7.3(m)(3): Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. The FDA's recalls-background page and its CGMP explainer returned an abuse-detection block and are not cited.

What is still unknown or disputed

  • What the manufacturing failure was. The entries say CGMP deviations and stop there.
  • Whether anyone got sick. The entries do not say.
  • How to send a tube back, or whether there is a refund. The entries do not include consumer instructions.
  • The openFDA drug-enforcement index. It was last updated Oct. 14, 2026, and a search for D-0053-2027 returned no matches. The figures in this story are from the enforcement-report records for event 99849, which were posted Oct. 19. The entry's enforcement-report date is Oct. 28.
  • The FDA's own web page defining CGMP. It did not load. The expansion of the abbreviation in this story is the ordinary name of those letters, not a sentence copied from that page.

Primary sources

Every claim in this story is drawn from the documents below. If a fetch failed, that is recorded on the card.

  1. Source 1

    Enforcement report event 99849, Pritam International toothpaste

    U.S. Food and Drug Administration · October 19, 2026

    Voluntary recall of about 4.3 million tubes, classified Class II on Oct. 19, 2026. Reason on the entries: CGMP deviations. Recall numbers D-0053-2027 through D-0069-2027.

    https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99849

  2. Source 2

    21 CFR 7.3, Definitions

    Electronic Code of Federal Regulations · October 25, 2026

    Class II: temporary or medically reversible health consequences, or a remote probability of serious harm.

    https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-7/subpart-A/section-7.3