CLASS II Drug recall · Reported 8 Aug 2012 · FDA Enforcement Report

Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled

Mallinckrodt is recalling Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per, distributed nationwide in the US. The recall was initiated on 25 May 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 0375P76192, Exp 07/12; 0375T80512, Exp 08/13; 0375T81209, Exp 09/13

Quantity recalled44,330 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-1431-2012
FDA event ID: 61967
Recalling firm: Mallinckrodt, Hobart, NY
Classification: Class II
Status: Terminated
Recall initiated: 25 May 2012
FDA classified: 31 Jul 2012
Reported: 8 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Pain Medication

Timeline

25 May 2012	Recall initiated by company
31 Jul 2012	Classified by FDA	+67 days
8 Aug 2012	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

CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.

Product as listed by the FDA

Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.

Which lots are affected?

Lot #: 0375P76192, Exp 07/12; 0375T80512, Exp 08/13; 0375T81209, Exp 09/13

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

1 other product · FDA event 61967

Reported	Class	Recall	Company	Reason	Where
8 Aug 2012	CLASS III	Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled	Mallinckrodt	Potency & Assay	Nationwide

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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