Use caution Drug recall · FDA · Published July 2, 2021

Harvard Drug Recalls Nifedipine 30mg Due to Dissolution Failure

The Harvard Drug Group recalls specific lots of Nifedipine 30mg extended-release tablets due to failed dissolution specifications. Check your lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0652-2021Drug The Harvard Drug Group ›

Use caution until it’s fixed

Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.

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Contact the company

Recalling firmThe Harvard Drug Group17187 N Laurel Park Dr Ste 300 · Livonia, MI 48152-2600

✎ GovInfoNow plain-language explainer

The Harvard Drug Group is recalling Nifedipine Extended-Release Tablets, USP 30 mg because they failed dissolution specifications during routine stability testing. This means the medication may not release or work as intended. The recall affects specific lots distributed in Ohio and New Jersey. Read more at govinfonow.com/recall/36102-harvard-drug-recalls-nifedipine-30mg-due-to-dissolution-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/36102-harvard-drug-recalls-nifedipine-30mg-due-to-dissolution-failure · Updated October 10, 2026 · FDA enforcement record: FDA #D-0652-2021

Cite this page

“Harvard Drug Recalls Nifedipine 30mg Due to Dissolution Failure.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/36102-harvard-drug-recalls-nifedipine-30mg-due-to-dissolution-failure. Based on FDA recall #D-0652-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0652-2021%22&limit=1).

The Harvard Drug Group recalled Nifedipine Extended-Release Tablets, USP 30 mg due to failed dissolution specifications, according to the FDA. The recall was announced on July 2, 2021.

How to tell if you have it

Brand: The Harvard Drug Group
Product: Nifedipine Extended-Release Tablets, USP 30 mg
NDC 0904-7080-61 (100 count unit dose carton)
NDC 0904-7080-06 (50 count unit dose carton)
Lot N00418, Exp. 09/2022
Lot N00417, Exp. 09/2022

The hazard

The tablets failed dissolution specifications during routine stability testing, according to the FDA.

Context

GovInfoNow's records show The Harvard Drug Group has 20 other recalls on record since 2016-07-15. Other recent recalls of similar products include Golden State NIACIN Extended-Release Tablets Recall: Failed Dissolution Testing (2026-05-29), Harvard Drug Group Memantine Capsules Recall: Failed Dissolution Specifications (2026-03-24), and Inventia Chlorthalidone Recall: Failed Dissolution Specs (2026-09-03).

How to tell if you have this one

Check if you have Nifedipine Extended-Release Tablets, USP 30 mg distributed by The Harvard Drug Group. Look for unit dose cartons of either 100 count (NDC 0904-7080-61) or 50 count (NDC 0904-7080-06). Affected lots are N00418 and N00417, both with an expiration date of 09/2022.

Brand
The Harvard Drug Group
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Medication
Verify if your Nifedipine tablets match the recalled lot numbers (N00418 or N00417) and expiration date (09/2022).
Contact Your Pharmacist
Speak with your pharmacist to determine if you have the recalled product and to discuss alternative treatment options.

Where it went and when

Where it was distributed

Distributed in New Jersey and Ohio.

FDA distribution: “Distributed in OH and NJ” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: New Jersey, Ohio.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

Jul 2, 2021Firm started the recall
Jul 9, 2021FDA classified it Class II
Jul 21, 2021Published in FDA’s Enforcement Report
Dec 28, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/36102-harvard-drug-recalls-nifedipine-30mg-due-to-dissolution-failure">Harvard Drug Recalls Nifedipine 30mg Due to Dissolution Failure (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0652-2021 (July 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0652-2021 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.