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Class II · ModerateRecall completed

Little Remedies

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 0855, Exp. 8/31/ 2025
Where it was soldRecalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMedtech Products Inc.
Brand nameLITTLE REMEDIES
Generic nameSIMTHICONE
Active ingredient(s)DIMETHICONE
Distributed by / forDenison Pharmaceuticals, LLC
NDC63029-103-02
Show the full FDA record
Full product labelLittle Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02
Recalling firmDenison Pharmaceuticals, LLC
DistributionRecalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
Quantity113,544 bottles
Recall initiated2024-05-28
Report date2024-06-26
Recall completed2025-08-26
Recall numberD-0557-2024
ClassificationClass II
FDA statusTerminated
Origin on fileLincoln RI United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.