CLASS I Drug recall · Reported 28 Dec 2016 · FDA Enforcement Report
Docusate Oral 10 mg/mL Oral Syringe recalled by US Compounding
US Compounding is recalling Docusate Oral 10 mg/mL Oral Syringe, distributed in Texas. The recall was initiated on 25 Jul 2016 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0219-2017
- FDA event ID
- 74792
- Recalling firm
- US Compounding, Conway, AR
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 25 Jul 2016
- FDA classified
- 22 Dec 2016
- Reported
- 28 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 25 Jul 2016 | Recall initiated by company | |
| 22 Dec 2016 | Classified by FDA | +150 days |
| 28 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
TX
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
Which lots are affected?
All Lots
Where was it sold?
TX
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from US Compounding
All 65| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Succinylcholine Chloride PF Inj recalled by US Compounding | US Compounding | Other | Nationwide |
| Drug | CLASS III | Neostigmine Methylsulfate PF Inj recalled by US Compounding | US Compounding | Labeling Errors | Nationwide |
| Drug | CLASS II | Ephedrine Sulfate, 50 mg/ Single Use Syringe recalled by US Compounding | US Compounding | Sterility | Nationwide |
| Drug | CLASS II | LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + recalled | US Compounding | Other | Nationwide |
| Drug | CLASS II | Fentanyl PF (25 mcg/mL) Single Use Syringe, For IV recalled | US Compounding | Sterility | Nationwide |
Other Docusate recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Docusate Sodium 250 mg in blister card-foils unit dose recalled | Safecor Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Sankaijo Botanical Laxative (docusate sodium 8.33 mg recalledSankaijo | Sato Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS II | Docusate Sodium, 100mg softgels recalled by Rx Pak Division of McKesson | Rx Pak Division of McKesson | Packaging Defects | Nationwide |
| Drug | CLASS II | Docusate Calcium Softgel Capsules, 240 mg recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
| Drug | CLASS II | Docusate Calcium, Capsule, 240 mg, Over The Counter recalled | Aidapak Services | Labeling Errors | 4 states |