Little Remedies Gas Relief Drops Class II Recall for Manufacturing Deviations
Denison Pharmaceuticals recalls 113,544 bottles of Little Remedies Gas Relief Drops (Lot #0855, exp. 8/31/2025) due to manufacturing deviations. All units have been recovered and controlled at the manufacturer.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification indicates potential for adverse health consequences. However, no illnesses or injuries have been reported, and all units were recovered (100%). The contamination resulted from personnel error rather than confirmed product defect, making the actual hazard theoretical despite the high-risk pathogen involved.
Plain-English summary
Denison Pharmaceuticals, LLC is recalling 113,544 bottles of Little Remedies Gas Relief Drops (Simethicone), an over-the-counter antacid medication used for gas relief. The affected product is packaged in 1 fl oz (30 mL) bottles with droppers and carries lot number 0855, with an expiration date of August 31, 2025. The manufacturer is Denison Pharmaceuticals, and the distributor is Medtech Products Inc., Tarrytown, NY.
The recall was issued due to current Good Manufacturing Practice (cGMP) deviations. Test results detected Burkholderia cepacia, a bacterium associated with potential infections. This contamination was determined to result from personnel error in the manufacturing or testing process.
All 113,544 recalled units were distributed to a single customer and have been recovered and controlled at Denison Pharmaceuticals, representing 100% recovery. No illnesses or adverse events have been reported in connection with this product.
Consumers who possess this product should not use it. Questions may be directed to a healthcare provider.
The recalled product
- Product
- LITTLE REMEDIES (SIMTHICONE)
- Brand
- LITTLE REMEDIES
- Manufacturer
- Denison Pharmaceuticals, LLC
- Category
- Drug — OTC Antacid
- Affected units
- 113,544
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 0855
- Exp. 8/31/ 2025
Distribution
Distribution scope not specified by the agency.
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