CLASS II Drug recall · Reported 8 Feb 2017 · FDA Enforcement Report

Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled

VistaPharm is recalling Hydrocodone Bitartrate and Acetaminophen Oral Solution, 5 mg/325 mg per 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

Lot, batch or date codesa). Lot No. 419000 (Exp. 03/17) b.) Lot No. 419800 (Exp. 03/17), 429100 (Exp. 06/17) c). Lot No. 418200 (Exp. 03/17), 430100 (Exp. 06/17), 423800 (Exp. 04/17), 413100 (Exp. 02/17), 410700 (Exp. 01/17)

Quantity recalled32,027 bottles and 16,310 unit dose cups

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-0458-2017
FDA event ID: 75650
Recalling firm: VistaPharm, Largo, FL
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
Drug class: Pain Medication

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

Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771

Where it was distributed

Nationwide

Questions about this recall

Is Hydrocodone Bitartrate and Acetaminophen Oral Solution, 5 mg/325 mg per C-II, a) . ( recalled?

Yes. VistaPharm recalled Hydrocodone Bitartrate and Acetaminophen Oral Solution, 5 mg/325 mg per C-II, a) . ( on 18 Jan 2017. The recall is Class II and its status is Terminated. Recall number D-0458-2017.

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. 419000 (Exp. 03/17) b.) Lot No. 419800 (Exp. 03/17), 429100 (Exp. 06/17) c). Lot No. 418200 (Exp. 03/17), 430100 (Exp. 06/17), 423800 (Exp. 04/17), 413100 (Exp. 02/17), 410700 (Exp. 01/17)

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 21 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 VistaPharm

All 36

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6 Dec 2023Drug	CLASS III	Aminocaproic Acid Oral Solution/mL recalled by VistaPharm	VistaPharm	Packaging Defects	Nationwide
15 Nov 2023Drug	CLASS III	Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL recalledMycophenolate Mofetil	VistaPharm	Other	Nationwide
25 Oct 2023Drug	CLASS I	Sucralfate Oral Suspension per PET bottle) recalled by VistaPharmSucralfate	VistaPharm	Sterility	Nationwide
20 Sep 2023Drug	CLASS II	Sucralfate Oral Suspension per, For Oral Administration Only bottle) recalledSucralfate	VistaPharm	Potency & Assay	Nationwide
2 Nov 2022Drug	CLASS II	Pyridostigmine Bromide Oral Solution, USP 60 mg/ Delivers recalledPyridostigmine Bromide	VistaPharm	Potency & Assay	Nationwide

Other Hydrocodone bitartrate and acetaminophen recalls

All 11

Reported	Class	Recall	Company	Reason	Where
25 Nov 2020Drug	CLASS II	Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg recalled	Ascent Pharmaceuticals	Other	Nationwide
20 Sep 2017Drug	CLASS III	Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled	VistaPharm	Labeling Errors	Nationwide
5 Feb 2014Drug	CLASS II	Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII recalled	Watson Laboratories	Other	Nationwide
25 Sep 2013Drug	CLASS III	Hydrocodone Bitartrate and Acetaminophen Tablets, 5 mg recalled	Watson Laboratories	Packaging Defects	Nationwide
27 Feb 2013Drug	CLASS I	Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg recalled	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Potency & Assay	Nationwide