Little Remedies Gas Relief Drops (Simethicone/Antigas) recall
FDA recall D-0557-2024 · initiated May 28, 2024
Denison Pharmaceuticals, LLC recalled Little Remedies Gas Relief Drops (Simethicone/Antigas) in May 2024 — an FDA Class II recall (D-0557-2024) because cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 113,544 bottles
Details
- Product
- Little 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 company
- Denison Pharmaceuticals, LLC
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
- Initiated
- May 28, 2024
- FDA report date
- Jun 26, 2024
Frequently asked
- Was Little Remedies Gas Relief Drops (Simethicone/Antigas) recalled?
- Denison Pharmaceuticals, LLC recalled Little Remedies Gas Relief Drops (Simethicone/Antigas) in May 2024 — an FDA Class II recall (D-0557-2024) because cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Little Remedies Gas Relief Drops (Simethicone/Antigas) recalled?
- Per the FDA enforcement record, the reason for recall D-0557-2024 was: cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
- Is a recalled Little Remedies Gas Relief Drops (Simethicone/Antigas) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Little Remedies Gas Relief Drops (Simethicone/Antigas) are affected?
- Distributed: Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.. The recall covers these lots — Lot #: 0855, Exp. 8/31/ 2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0557-2024.