CLASS I Drug recall · Reported 28 Nov 2012 · FDA Enforcement Report
Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg recalled
Watson Laboratories is recalling Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/ per, distributed nationwide in the US. The recall was initiated on 21 Sep 2012 and the FDA has classified it as Class I.
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-058-2013
- FDA event ID
- 63246
- Recalling firm
- Watson Laboratories, Corona, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 21 Sep 2012
- FDA classified
- 16 Nov 2012
- Reported
- 28 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 21 Sep 2012 | Recall initiated by company | |
| 16 Nov 2012 | Classified by FDA | +56 days |
| 28 Nov 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Which lots are affected?
Lot #: 519406A, 521759A, Exp 04/14
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII recalled | Watson Laboratories | Other | Nationwide |
| 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, 7.5 mg recalled | Watson Laboratories | Packaging Defects | Nationwide |
Other Hydrocodone Bitartrate recalls
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg recalledHydrocodone Bitartrate And Acetaminophen | Ascent Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Hydrocodone Bitartrate and Homatropine Methlybromide recalledHydrocodone Bitartrate And Homatropine Methylbromide | Kvk-Tech | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg recalled | Ascent Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Hydrocodone Bitartrate and Homatropine Methlybromide Oral recalledHydrocodone Bitartrate And Homatropine Methylbromide | Kvk-Tech | Particulate Matter | Nationwide |
| Drug | CLASS II | Hydrocodone Bitartrate and Homatropine Methylbromide Oral recalled | Torrent Pharma | Sterility | Nationwide |