US Compounding Docusate Oral mg/mL Syringe Recall: FDA Class I

Why it was recalled

Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia

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

Lot numbers, UPCs & expiration codes

All Lots

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0219-2017
Classification: Class I
Status: Terminated
Recall initiated: Jul 25, 2016
FDA report date: Dec 28, 2016
Quantity: 10,665 syringes
Recall type: Voluntary: Firm initiated
Recalling firm: US Compounding Inc

Original FDA data

Every field from FDA enforcement report D-0219-2017, exactly as published.

Show all FDA fields

City: Conway
State: AR
Status: Terminated
Country: United States
Event ID: 74792
Address: 1270 Don's Lane
Code information: All Lots
Postal code: 72032
Report date: Dec 28, 2016
Product type: Drugs
Recall number: D-0219-2017
Classification: Class I
Recalling firm: US Compounding Inc
Product quantity: 10,665 syringes
Termination date: Apr 6, 2017
Reason for recall: Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
Voluntary / mandated: Voluntary: Firm initiated
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
Distribution pattern: TX
Recall initiation date: Jul 25, 2016
Initial firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date: Dec 22, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0219-2017, published Dec 28, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

US Compounding Docusate Oral 10 mg/mL Oral Syringe Recall

Summary