CLASS III Drug recall · Reported 12 Apr 2017 · FDA Enforcement Report
Adalat CC (nifedipine) Extended-Release Tablets, 60 mg recalled
Alvogen is recalling Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, distributed nationwide in the US. The recall was initiated on 7 Mar 2017 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-0634-2017
- FDA event ID
- 76664
- Recalling firm
- Alvogen, Pine Brook, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Mar 2017
- FDA classified
- 4 Apr 2017
- Reported
- 12 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 7 Mar 2017 | Recall initiated by company | |
| 4 Apr 2017 | Classified by FDA | +28 days |
| 12 Apr 2017 | 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
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Product as listed by the FDA
Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749501
Where it was distributed
Nationwide
Questions about this recall
Is Adalat CC (nifedipine) Extended-Release Tablets, 60 mg recalled?
Yes. Alvogen recalled Adalat CC (nifedipine) Extended-Release Tablets, 60 mg on 7 Mar 2017. The recall is Class III and its status is Terminated. Recall number D-0634-2017.
Why was it recalled?
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Which lots are affected?
Lot #: BXCUE1A, Exp. 01/2019
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 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.
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