CLASS III Drug recall · Reported 30 Nov 2016 · FDA Enforcement Report
NIFEdipine Capsules USP, 10 mg recalled by Actavis Elizabeth
Actavis Elizabeth is recalling NIFEdipine Capsules USP, 10 mg. The recall was initiated on 6 Oct 2016 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-0143-2017
- FDA event ID
- 75445
- Recalling firm
- Actavis Elizabeth, Elizabeth, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Oct 2016
- FDA classified
- 18 Nov 2016
- Reported
- 30 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 6 Oct 2016 | Recall initiated by company | |
| 18 Nov 2016 | Classified by FDA | +43 days |
| 30 Nov 2016 | Published in enforcement report | +12 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 Tablets/Capsules
Product as listed by the FDA
NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-2407-10
Where it was distributed
US
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules
Which lots are affected?
Lot # 0598B151; Exp 03/18
Where was it sold?
US
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 Elizabeth
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg recalled | Actavis Elizabeth | Potency & Assay | Nationwide |
Other Nifedipine recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | NIFEdipine Extended-release Tablets, USP 30 mg recalledNifedipine | The Harvard Drug Group | Potency & Assay | NJ, OH |
| Drug | CLASS III | Nifedipine Extended-Release Tablets, 30 mg recalled by Alvogen | Alvogen | Other | Nationwide |
| Drug | CLASS III | Nifedipine Extended-Release Tablets, 60 mg recalled by Alvogen | Alvogen | Other | Nationwide |
| Drug | CLASS III | Nifedipine Extended-Release Tablets, 90 mg recalled by Alvogen | Alvogen | Other | Nationwide |
| Drug | CLASS II | Nifedipine Extended-Release Tablets, USP, 90 mg recalled | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |