CLASS I Drug recall · Reported 24 Sep 2014 · FDA Enforcement Report
Oxcarbazepine Tablets, 300 mg per carton (10 x recalled
American Health Packaging is recalling Oxcarbazepine Tablets, 300 mg per carton (10 x, distributed nationwide in the US. The recall was initiated on 1 Jul 2014 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-1590-2014
- FDA event ID
- 68779
- Recalling firm
- American Health Packaging, Columbus, OH
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 1 Jul 2014
- FDA classified
- 18 Sep 2014
- Reported
- 24 Sep 2014
- 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
- Seizure Medication
Timeline
| 1 Jul 2014 | Recall initiated by company | |
| 18 Sep 2014 | Classified by FDA | +79 days |
| 24 Sep 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
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544.
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
Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 62584-143-01
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544.
Which lots are affected?
Lot #142544, Exp 02/2016
Where was it sold?
Nationwide and Puerto Rico
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 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.
Other products in this recall event
1 other product · FDA event 68779This product is part of a recall event; the main page for the event is Ibuprofen Tablets, USP, 600 mg per carton (10 x recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Ibuprofen Tablets, USP, 600 mg per carton (10 x recalled | American Health Packaging | Packaging Defects | Nationwide |
More recalls from American Health Packaging
All 60| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Buprenorphine Sublingual Tablets (C-iii), 2 mg recalledBuprenorphine | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS III | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Cyanocobalamin Injection, USP, 1000 mcg per mL recalled | American Health Packaging | Potency & Assay | AL |
| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP 50 mg recalledMetoprolol Succinate | American Health Packaging | Potency & Assay | Nationwide |
Other Oxcarbazepine recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Oxcarbazepine Oral Suspension, USP, 300 mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxcarbazepine Tablets 600mg recalled by Sun Pharmaceutical IndustriesOxcarbazepine | Sun Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxcarbazepine Oral Suspension, USP, 300 mg recalled | West-Ward Columbus | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxcarbazepine Tablets, 300 mg recalled by Caraco PharmaceuticalOxcarbazepine | Caraco Pharmaceutical Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | OXcarbazepine Tablet, 600 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |