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
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 ArizonaCaliforniaConnecticutFloridaNevadaOhioOklahomaPennsylvaniaSouth CarolinaWisconsin
Questions about this recall
Is Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg recalled?
Yes. Watson Laboratories recalled Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg on 15 Jan 2014. The recall is Class II and its status is Terminated. Recall number D-1053-2014.
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 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 Watson Laboratories
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carisoprodol Tablets, USP, CIV, 350 mg recalled by Watson Laboratories | Watson Laboratories | Particulate Matter | Nationwide |
| Drug | CLASS II | Next Choice" One Dose Emergency Contraceptive recalled | Watson Laboratories | Other | Nationwide |
| Drug | CLASS II | Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII recalled | Watson Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS III | Hydrocodone Bitartrate and Acetaminophen Tablets, 5 mg recalled | Watson Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS III | Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg recalled | Watson Laboratories | Potency & Assay | Nationwide |
Other Hydrocodone bitartrate and acetaminophen recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg recalled | Ascent Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled | VistaPharm | Labeling Errors | Nationwide |
| Drug | CLASS II | Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled | VistaPharm | Sterility | Nationwide |
| Drug | CLASS III | Hydrocodone Bitartrate and Acetaminophen Tablets, 5 mg recalled | Watson Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS I | Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg recalled | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Potency & Assay | Nationwide |