CLASS II Drug recall · Reported 15 Aug 2012 · FDA Enforcement Report
Meloxicam Tablets, USP, 15 mg recalled by Apotex
Apotex is recalling Meloxicam Tablets, USP, 15 mg, distributed nationwide in the US. The recall was initiated on 5 Apr 2012 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-1443-2012
- FDA event ID
- 62436
- Recalling firm
- Apotex, Weston, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Apr 2012
- FDA classified
- 7 Aug 2012
- Reported
- 15 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 5 Apr 2012 | Recall initiated by company | |
| 7 Aug 2012 | Classified by FDA | +124 days |
| 15 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
Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.
Product as listed by the FDA
Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076, India, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-3579-1.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.
Which lots are affected?
Lot: 7212558, Exp 12/12.
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 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 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.
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Other Meloxicam recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Meloxicam Tablets, USP, 15 mg recalled by Cardinal HealthcareMeloxicam | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Meloxicam Tablets, USP 7.5 mg recalled by Cardinal HealthMeloxicam | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Meloxicam capsules, 12 mg recalled by South Coast Specialty | South Coast Specialty Compounding | Other | Nationwide |
| Drug | CLASS II | Meloxicam 5 mg/ml Injection, compounded by Olympia Pharmacy recalled | Lowlite Investments | Sterility | Nationwide |