CLASS II Drug recall · Reported 8 Feb 2017 · FDA Enforcement Report
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) recalled
VistaPharm is recalling Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) (, distributed nationwide in the US. The recall was initiated on 18 Jan 2017 and the FDA has classified it as Class II.
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-0465-2017
- FDA event ID
- 75650
- Recalling firm
- VistaPharm, Largo, FL
- Manufacturer
- VistaPharm, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jan 2017
- FDA classified
- 2 Feb 2017
- Reported
- 8 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
Timeline
| 18 Jan 2017 | Recall initiated by company | |
| 2 Feb 2017 | Classified by FDA | +15 days |
| 8 Feb 2017 | 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
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia 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
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 liter (1000 mL), 4 bottles per case, (NDC No. 66689-695-79), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Which lots are affected?
a). Lot No. 416600 (Exp. 09/17) b). Lot No.449100 , 447500 (Exp. 04/18), 421800 (Exp. 10/17), 418600 (Exp. 09/17), 408700 (Exp. 06/17), 411900 (Exp. 07/17), 413800 (Exp. 08/17), 416500 (Exp. 09/17), 408500 (Exp. 06/17), 389800 (Exp. 01/17), 429900 (Exp. 12/17), 406300, 406100 (Exp. 05/17), 429700 (Exp. 12/17), 427300, 427100, 425900 (11/17)
Where was it sold?
Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
10 other products · FDA event 75650This product is part of a recall event; the main page for the event is Metoclopramide Oral Solution, USP 10 mg/ dose cups recalled.
More recalls from VistaPharm
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Aminocaproic Acid Oral Solution/mL recalled by VistaPharm | VistaPharm | Packaging Defects | Nationwide |
| Drug | CLASS III | Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL recalledMycophenolate Mofetil | VistaPharm | Other | Nationwide |
| Drug | CLASS I | Sucralfate Oral Suspension per PET bottle) recalled by VistaPharmSucralfate | VistaPharm | Other Bacterial Contamination | Nationwide |
| Drug | CLASS II | Sucralfate Oral Suspension per, For Oral Administration Only bottle) recalledSucralfate | VistaPharm | Potency & Assay | Nationwide |
| Drug | CLASS II | Pyridostigmine Bromide Oral Solution, USP 60 mg/ Delivers recalledPyridostigmine Bromide | VistaPharm | Potency & Assay | Nationwide |
Other Methadone recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Methadone Hydrochloride Tablets, USP, 5mg, Unit-Dose Tablets recalledMethadone Hydrochloride | West-Ward Columbus | Other | Nationwide |
| Drug | CLASS II | Methadone HCl Injection in all strengths, all doses recalled | Pharmedium Services | Sterility | Nationwide |
| Drug | CLASS II | Methadone HCl in 0.9% Sodium Chloride in all strengths recalled | Pharmedium Services | Sterility | Nationwide |
| Drug | CLASS II | Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II recalledMethadone Hydrochloride | VistaPharm | Sterility | Nationwide |
| Drug | CLASS II | methadone HCl, 1 mg per mL recalled by Pharmedium Services | Pharmedium Services | Potency & Assay | Nationwide |