CLASS II Drug recall · Reported 5 Feb 2014 · FDA Enforcement Report

Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII recalled

Watson Laboratories is recalling Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, distributed nationwide in the US. The recall was initiated on 15 Jan 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 697316A, Expiry: Mar 2015.

Quantity recalled717 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-1053-2014
FDA event ID: 67348
Recalling firm: Watson Laboratories, Corona, CA
Classification: Class II
Status: Terminated
Recall initiated: 15 Jan 2014
FDA classified: 30 Jan 2014
Reported: 5 Feb 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Pain Medication

Timeline

15 Jan 2014	Recall initiated by company
30 Jan 2014	Classified by FDA	+15 days
5 Feb 2014	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

Failed Tablet/Capsule Specifications; Product contains broken tablets.

Product as listed by the FDA

Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only. Manufactured by Watson Laboratories, Inc., Corona, CA 92880. Distributed by: Watson Pharma, Inc. NDC: 00591-0517-01.

Where it was distributed

Nationally in: AZ, CA, CT, FL, NV, OH, OK, PA, SC, WI.

Nationwide Arizona California Connecticut Florida Nevada Ohio Oklahoma Pennsylvania South Carolina Wisconsin

Questions about this recall

Why was it recalled?

Failed Tablet/Capsule Specifications; Product contains broken tablets.

Which lots are affected?

Lot #: 697316A, Expiry: Mar 2015.

Where was it sold?

Nationally in: AZ, CA, CT, FL, NV, OH, OK, PA, SC, WI.

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.

More recalls from Watson Laboratories

All 22

Reported	Class	Recall	Company	Reason	Where
15 Jan 2014Drug	CLASS II	Carisoprodol Tablets, USP, CIV, 350 mg recalled by Watson Laboratories	Watson Laboratories	Particulate Matter	Nationwide
16 Oct 2013Drug	CLASS II	Next Choice" One Dose Emergency Contraceptive recalled	Watson Laboratories	Other	Nationwide
9 Oct 2013Drug	CLASS II	Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII recalled	Watson Laboratories	Packaging Defects	Nationwide
25 Sep 2013Drug	CLASS III	Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg recalled	Watson Laboratories	Packaging Defects	Nationwide
31 Jul 2013Drug	CLASS III	Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg recalled	Watson Laboratories	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