CLASS II Drug recall · Reported 21 Jul 2021 · FDA Enforcement Report
NIFEdipine Extended-release Tablets, USP 30 mg recalled
The Harvard Drug Group is recalling NIFEdipine Extended-release Tablets, USP 30 mg, distributed in New Jersey, Ohio. The recall was initiated on 2 Jul 2021 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-0652-2021
- FDA event ID
- 88224
- Recalling firm
- The Harvard Drug Group, Livonia, MI
- Brand
- Nifedipine
- Manufacturer
- Major Pharmaceuticals
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jul 2021
- FDA classified
- 9 Jul 2021
- Reported
- 21 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 2 Jul 2021 | Recall initiated by company | |
| 9 Jul 2021 | Classified by FDA | +7 days |
| 21 Jul 2021 | 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
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count unit dose carton, NDC 0904-7080-06: Distributed by: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA
Where it was distributed
Distributed in OH and NJ
Questions about this recall
Why was it recalled?
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Which lots are affected?
Lots: a)N00418 Exp. 09/2022, b) N00417 Exp. 09/2022
Where was it sold?
Distributed in OH and NJ
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 The Harvard Drug Group
All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carton Label: Major, Methylergonovine Maleate Tablets recalledMethylergonovine Maleate | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Omega-3-Acid, Ethyl Esters, Capsules recalled by The Harvard Drug GroupOmega-3-acid Ethyl Esters | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalledMemantine Hydrochloride | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Midodrine Hydrochloride Tablets, USP, 5 mg ( blister packs) recalledMidodrine Hydrochloride | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister packs) recalledGabapentin | The Harvard Drug Group | Potency & Assay | Nationwide |
Other Nifedipine recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 III | NIFEdipine Capsules USP, 10 mg recalled by Actavis Elizabeth | Actavis Elizabeth | Other | NJ |
| Drug | CLASS II | Nifedipine Extended-Release Tablets, USP, 90 mg recalled | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |