Has The Harvard Drug Group LLC had product recalls?

Yes, 3 recalls on file. See the full history below for each one.

Is this FDA enforcement data for The Harvard Drug Group LLC official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

What is the most recent FDA action against The Harvard Drug Group LLC?

The most recent FDA event Argus HQ has on file for The Harvard Drug Group LLC is dated 2026-07-01, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

FDA Actions Against The Harvard Drug Group LLC

Here's the summary: Argus HQ has recorded 3 FDA events for The Harvard Drug Group LLC: 0 warning letters, 3 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-04-22 to 2026-07-01. The most severe rating Argus HQ has assigned across this history is "high". Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

FDA action counts

Total FDA actions	3
Warning letters	0
Recalls	3
Approval records	0
Form 483 inspection citations	0
Most recent action	July 1, 2026

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. The Harvard Drug Group LLC has 3 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Enforcement history

On 2026-04-22, Argus HQ recorded a FDA recall for The Harvard Drug Group LLC, rated "high" severity in Argus HQ's classification: The Harvard Drug Group LLC — Class II recall: Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for The Harvard Drug Group LLC, rated "high" severity in Argus HQ's classification: The Harvard Drug Group LLC — Class II recall: Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for The Harvard Drug Group LLC, rated "high" severity in Argus HQ's classification: The Harvard Drug Group LLC — Class II recall: Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, The Harvard Drug Group LLC has 3 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations). Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Frequently asked questions

Has The Harvard Drug Group LLC had product recalls?: Yes, 3 recalls on file. See the full history below for each one.
Is this FDA enforcement data for The Harvard Drug Group LLC official?: Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
How many FDA actions has The Harvard Drug Group LLC had?: Argus HQ has recorded 3 FDA events for The Harvard Drug Group LLC: 0 warning letters, 3 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
What is the most recent FDA action against The Harvard Drug Group LLC?: The most recent FDA event Argus HQ has on file for The Harvard Drug Group LLC is dated 2026-07-01, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Actions Against The Harvard Drug Group LLC. Digital Empire LLC. Retrieved from https://argushq.ai/company/the-harvard-drug-group-llc

MLA

"FDA Actions Against The Harvard Drug Group LLC." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/the-harvard-drug-group-llc.

Chicago

Argus HQ Research. "FDA Actions Against The Harvard Drug Group LLC." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/the-harvard-drug-group-llc.

BibTeX

@misc{argushq_argushq_ai_company_the_harvard_drug_group_llc_2026,
  title = {FDA Actions Against The Harvard Drug Group LLC},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/the-harvard-drug-group-llc},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗