CLASS II Drug recall · Reported 12 Dec 2012 · FDA Enforcement Report
traMADOL Hydrochloride Tablets recalled by Caraco Pharmaceutical
Caraco Pharmaceutical Laboratories is recalling traMADOL Hydrochloride Tablets, USP per, distributed nationwide in the US. The recall was initiated on 5 Nov 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-089-2013
- FDA event ID
- 63628
- Recalling firm
- Caraco Pharmaceutical Laboratories, Detroit, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Nov 2012
- FDA classified
- 6 Dec 2012
- Reported
- 12 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 5 Nov 2012 | Recall initiated by company | |
| 6 Dec 2012 | Classified by FDA | +31 days |
| 12 Dec 2012 | 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
Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.
Product as listed by the FDA
traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industries, Dadra 396 191, India; Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; NDC 57664-377-18.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.
Which lots are affected?
Lot # GKK1373, Exp 09/13
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.
More recalls from Caraco Pharmaceutical Laboratories
All 12Other Tramadol recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | traMADol Hydrochloride Tablets, USP, 50 mg recalled | Amneal Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | traMADol Hydrochloride Tablets, USP 50 mg recalledTramadol Hydrochloride | Rubicon Research Private | Other | Nationwide |
| Drug | CLASS II | TraMADol HCl, Packaged as (a) recalled by RemedyRepack | RemedyRepack | Packaging Defects | Nationwide |
| Drug | CLASS II | Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose Tablets recalled | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Tramadol Hydrochloride Tablets USP 100mg recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |