CLASS III Drug recall · Reported 25 Sep 2013 · FDA Enforcement Report
Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg recalled
Watson Laboratories is recalling Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg, distributed nationwide in the US. The recall was initiated on 30 Aug 2013 and the FDA has classified it as Class III.
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-1061-2013
- FDA event ID
- 66169
- Recalling firm
- Watson Laboratories, Corona, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 30 Aug 2013
- FDA classified
- 17 Sep 2013
- Reported
- 25 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 30 Aug 2013 | Recall initiated by company | |
| 17 Sep 2013 | Classified by FDA | +18 days |
| 25 Sep 2013 | 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
Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Laboratories, Inc, Cocona, CA 92880, NDC 0591-2611-05.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.
Which lots are affected?
Lot 706224A and 706225A, Exp. 04/15.
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 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 | 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 |
|---|---|---|---|---|---|
| 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 |