CLASS III Drug recall · Reported 22 Apr 2015 · FDA Enforcement Report
Cartia XT (diltiazem HCl extended-release capsules, USP) recalled
Actavis Laboratories FL is recalling Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, distributed nationwide in the US. The recall was initiated on 26 Mar 2015 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-0488-2015
- FDA event ID
- 70849
- Recalling firm
- Actavis Laboratories FL, Davie, FL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 26 Mar 2015
- FDA classified
- 15 Apr 2015
- Reported
- 22 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 26 Mar 2015 | Recall initiated by company | |
| 15 Apr 2015 | Classified by FDA | +20 days |
| 22 Apr 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell
Product as listed by the FDA
Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA --- NDC 62037-0600-90
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell
Which lots are affected?
Lot # 956000M, Exp. Aug 2016; UPC 3-6203760090-6
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 Actavis Laboratories FL
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|---|---|---|---|---|---|
| Drug | CLASS III | Ramipril Capsules, USP, 1.25 mg recalled by Actavis Laboratories, FL | Actavis Laboratories FL | Other | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, 1000 mg recalled | Actavis Laboratories FL | Potency & Assay | Nationwide |
| Drug | CLASS III | Desmopressin Acetate Tablets, 0.1mg recalled by Actavis Laboratories, FL | Actavis Laboratories FL | Other | Nationwide |
| Drug | CLASS II | Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalled | Actavis Laboratories FL | Other | Nationwide |
| Drug | CLASS II | Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalled | Actavis Laboratories FL | Other | Nationwide |
Other Cartia Xt (diltiazem recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cartia XT (Diltiazem Hydrochloride Extended-Release recalled | Teva Pharmaceuticals USA | Other | Nationwide |