Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported December 28, 2016
Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
US Compounding Inc recalled Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295… - a critical-severity action.
Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295… was recalled by US Compounding Inc in December 28, 2016. Reason: Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia. Check the official notice for the remedy. Verify recall #D-0219-2017 with the FDA Drug before acting.
The recall
US Compounding Inc issued this critical-severity FDA Drug recall-Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia.
- Critical
- severity level
- Class I
- classification
- December 28, 2016
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0219-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0219-2017) was formally reported on December 28, 2016, with the manufacturer initiating the action on July 25, 2016. It is classified under Critical severity (Class I), with a current status of Terminated. US Compounding Inc is listed as the recalling firm, operating out of Conway, AR. Federal records list the affected scope as 10,665 syringes.
The documented reason for this recall is: Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia Distribution data in the federal record shows the product reached: TX. 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.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10,665 syringes
Related Recalls
6
0 from same agency
Product description
Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR
Reason for recall
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0219-2017 |
| Date reported | December 28, 2016 |
| Date initiated | July 25, 2016 |
| Recalling firm | US Compounding Inc |
| Firm location | Conway, AR |
| Affected scope | 10,665 syringes |
| Distribution | TX |
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-0219-2017) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR. Recalled by US Compounding Inc. Units affected: 10,665 syringes.
Why was this product recalled? ▼
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 28, 2016. Severity: Critical. Recall number: D-0219-2017.
Where was the recalled product distributed? ▼
Distribution: TX.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0219-2017) 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.
Nearby Recalls in This Category
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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 December 28, 2016. 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.