CLASS III Drug recall · Reported 20 Sep 2017 · FDA Enforcement Report

Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled

VistaPharm is recalling Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per (Cherry Flavored), distributed nationwide in the US. The recall was initiated on 17 Aug 2017 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot: 494700 Exp. 10/2018

Quantity recalled3084 bottles

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-1139-2017
FDA event ID: 77998
Recalling firm: VistaPharm, Largo, FL
Classification: Class III
Status: Terminated
Recall initiated: 17 Aug 2017
FDA classified: 12 Sep 2017
Reported: 20 Sep 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Drug class: Pain Medication

Timeline

17 Aug 2017	Recall initiated by company
12 Sep 2017	Classified by FDA	+26 days
20 Sep 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance

Product as listed by the FDA

Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance

Which lots are affected?

Lot: 494700 Exp. 10/2018

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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 VistaPharm

All 36

Reported	Class	Recall	Company	Reason	Where
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 recalled	VistaPharm	Other	Nationwide
25 Oct 2023Drug	CLASS I	Sucralfate Oral Suspension per PET bottle) recalled by VistaPharmSucralfate	VistaPharm	Other Bacterial Contamination	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 recalls

All 19

Reported	Class	Recall	Company	Reason	Where
15 Dec 2021Drug	CLASS II	Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg recalledHydrocodone Bitartrate And Acetaminophen	Ascent Pharmaceuticals	Packaging Defects	Nationwide
26 May 2021Drug	CLASS III	Hydrocodone Bitartrate and Homatropine Methlybromide recalledHydrocodone Bitartrate And Homatropine Methylbromide	Kvk-Tech	Potency & Assay	Nationwide
25 Nov 2020Drug	CLASS II	Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg recalled	Ascent Pharmaceuticals	Other	Nationwide
20 Nov 2019Drug	CLASS II	Hydrocodone Bitartrate and Homatropine Methlybromide Oral recalledHydrocodone Bitartrate And Homatropine Methylbromide	Kvk-Tech	Particulate Matter	Nationwide
19 Jun 2019Drug	CLASS II	Hydrocodone Bitartrate and Homatropine Methylbromide Oral recalled	Torrent Pharma	Sterility	Nationwide