CLASS III 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 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-1430-2012
- FDA event ID
- 61967
- Recalling firm
- Mallinckrodt, Hobart, NY
- Classification
- Class III
- 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
- Potency & Assay
- 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
Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
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 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?
Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
Which lots are affected?
Lot #: 0375T79384, Exp 05/13; 0375T81348, Exp 09/13; 0375U82277, Exp 01/14
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 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.
Other products in this recall event
1 other product · FDA event 61967This product is part of a recall event; the main page for the event is Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled | Mallinckrodt | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Mallinckrodt
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | INOmax Dsir -(delivery system) delivers Inomax recalled by Mallinckrodt | Mallinckrodt | Device Malfunction | NJ |
| Drug | CLASS II | MD-Gastroview (Diatrizoate Meglumine recalled by MallinckrodtMd Gastroview | Mallinckrodt | Other | MO |
| Drug | CLASS III | Thallous Chloride Tl 201 Injection, Diagnostic Sterile recalled | Mallinckrodt | Packaging Defects | 11 states |
| Drug | CLASS II | Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled | Mallinckrodt | Manufacturing (CGMP) Deviations | Nationwide |
| Device | CLASS II | The Handi-Fil Disposable Syringe Fill Tube is a sterile recalled | Mallinckrodt | 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 |