Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported June 26, 2024
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
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Denison Pharmaceuticals, LLC recalled Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bot… - a moderate-severity action.
Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bot… was recalled by Denison Pharmaceuticals, LLC in June 26, 2024. Reason: cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.. Check the official notice for the remedy. Verify recall #D-0557-2024 with the FDA Drug before acting.
The recall
Denison Pharmaceuticals, LLC issued this moderate-severity FDA Drug recall-cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error..
- Moderate
- severity level
- Class II
- classification
- June 26, 2024
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0557-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0557-2024) was formally reported on June 26, 2024, with the manufacturer initiating the action on May 28, 2024. It is classified under Moderate severity (Class II), with a current status of Terminated. Denison Pharmaceuticals, LLC is listed as the recalling firm, operating out of Lincoln, RI. Federal records list the affected scope as 113,544 bottles.
The documented reason for this recall is: cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error. Distribution data in the federal record shows the product reached: Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
113,544 bottles
Related Recalls
6
0 from same agency
Product description
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
Reason for recall
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0557-2024 |
| Date reported | June 26, 2024 |
| Date initiated | May 28, 2024 |
| Recalling firm | Denison Pharmaceuticals, LLC |
| Firm location | Lincoln, RI |
| Affected scope | 113,544 bottles |
| Distribution | Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0557-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Denison Pharmaceuticals, LLC. Units affected: 113,544 bottles.
Why was this product recalled? ▼
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 26, 2024. Severity: Moderate. Recall number: D-0557-2024.
Where was the recalled product distributed? ▼
Distribution: Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0557-2024) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported June 26, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.