The Harvard Drug Group recalls

The Harvard Drug Group has 79 recalls on record with the FDA and USDA, the earliest in 2015 and the latest reported on 1 Jul 2026. 21 are still ongoing. 11 were reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls79since 2015

Last 12 months11reported

Class I56% of total

Ongoing21latest 1 Jul 2026

Recalls per month, last 24 months

click a bar for that month

3Nov '24 0 0 5Feb 0 2 0May 0 2 1Aug 2 7 0Nov 0 0 0Feb 1 2 0May 0 1 0Aug 0 0

Severity split

Class I 5 6%Class II 63 80%Class III 11 14%

Why the harvard drug group is recalled

Product types

Brands

By year

202645%
20251924%
202456%
202379%
202223%
202145%
2020911%
20172633%
201611%
201523%

Ongoing the harvard drug group recalls

21 active

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS II	Carton Label: Major, Methylergonovine Maleate Tablets recalledMethylergonovine Maleate	The Harvard Drug Group	Potency & Assay	Nationwide
29 Apr 2026Drug	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
22 Apr 2026Drug	CLASS II	Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalledMemantine Hydrochloride	The Harvard Drug Group	Potency & Assay	Nationwide
11 Mar 2026Drug	CLASS II	Midodrine Hydrochloride Tablets, USP, 5 mg ( blister packs) recalledMidodrine Hydrochloride	The Harvard Drug Group	Packaging Defects	Nationwide
29 Oct 2025Drug	CLASS II	Gabapentin Capsules, USP, 100 mg ( blister packs) recalled	The Harvard Drug Group	Potency & Assay	Nationwide
29 Oct 2025Drug	CLASS II	Gabapentin Capsules, USP, 100 mg ( blister pack) recalledGabapentin	The Harvard Drug Group	Potency & Assay	Nationwide

All the harvard drug group recalls, newest first

79 total

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS II	Carton Label: Major, Methylergonovine Maleate Tablets recalledMethylergonovine Maleate	The Harvard Drug Group	Potency & Assay	Nationwide
29 Apr 2026Drug	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
22 Apr 2026Drug	CLASS II	Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalledMemantine Hydrochloride	The Harvard Drug Group	Potency & Assay	Nationwide
11 Mar 2026Drug	CLASS II	Midodrine Hydrochloride Tablets, USP, 5 mg ( blister packs) recalledMidodrine Hydrochloride	The Harvard Drug Group	Packaging Defects	Nationwide
29 Oct 2025Drug	CLASS II	Gabapentin Capsules, USP, 100 mg ( blister packs) recalled	The Harvard Drug Group	Potency & Assay	Nationwide
29 Oct 2025Drug	CLASS II	Gabapentin Capsules, USP, 100 mg ( blister pack) recalledGabapentin	The Harvard Drug Group	Potency & Assay	Nationwide
15 Oct 2025Drug	CLASS II	Major ChlorproMAZINE Hydrochloride Tablets recalled	The Harvard Drug Group	Nitrosamine Impurity	Nationwide
15 Oct 2025Drug	CLASS II	Major ChlorproMAZINE Hydrochloride Tablets recalled	The Harvard Drug Group	Nitrosamine Impurity	Nationwide
15 Oct 2025Drug	CLASS II	Major ChlorproMAZINE Hydrochloride Tablets recalled	The Harvard Drug Group	Nitrosamine Impurity	Nationwide
15 Oct 2025Drug	CLASS II	Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg recalled	The Harvard Drug Group	Nitrosamine Impurity	Nationwide
15 Oct 2025Drug	CLASS II	Major ChlorproMAZINE Hydrochloride Tablets recalled	The Harvard Drug Group	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim	The Harvard Drug Group	Packaging Defects	Nationwide
17 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim	The Harvard Drug Group	Packaging Defects	Nationwide
27 Aug 2025Drug	CLASS II	Carvedilol Tablets USP, 12.5 mg recalled by The Harvard Drug GroupCarvedilol	The Harvard Drug Group	Nitrosamine Impurity	Nationwide
9 Jul 2025Drug	CLASS II	Gabapentin Capsules, USP, 100 mg recalled by The Harvard Drug GroupGabapentin	The Harvard Drug Group	Packaging Defects	Nationwide
9 Jul 2025Drug	CLASS II	Gabapentin Capsules, USP, 100 mg , blister pack recalled	The Harvard Drug Group	Packaging Defects	Nationwide
23 Apr 2025Drug	CLASS II	ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg recalled	The Harvard Drug Group	Nitrosamine Impurity	Nationwide
9 Apr 2025Drug	CLASS III	Tolterodine Tartrate Extended-Release Capsules, 2 mg Dose recalled	The Harvard Drug Group	Potency & Assay	Nationwide
26 Feb 2025Drug	CLASS II	Lorazepam Tablets, USP, 2mg, Unit Dose per carton ( blister packs) recalled	The Harvard Drug Group	Potency & Assay	Nationwide
26 Feb 2025Drug	CLASS II	Lorazepam Tablets, USP, 1mg, Unit Dose per carton ( blister packs) recalled	The Harvard Drug Group	Potency & Assay	Nationwide
26 Feb 2025Drug	CLASS II	Lorazepam Tablets, USP, 0.5mg, Unit Dose per carton ( blister packs) recalled	The Harvard Drug Group	Potency & Assay	Nationwide
12 Feb 2025Drug	CLASS II	Potassium Chloride Extended-Release Tablets, USP, 10 mEq recalledPotassium Chloride	The Harvard Drug Group	Potency & Assay	Nationwide
5 Feb 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules USP, 20 mg recalled	The Harvard Drug Group	Nitrosamine Impurity	Nationwide
27 Nov 2024Drug	CLASS II	Guaifenesin Dextromethorphan Syrup, 200 mg/20mg recalled	The Harvard Drug Group	Potency & Assay	Nationwide
27 Nov 2024Drug	CLASS II	Guaifenesin Dextromethorphan Syrup, 100 mg/10mg recalled	The Harvard Drug Group	Potency & Assay	Nationwide
20 Nov 2024Drug	CLASS III	Hydralazine HCl Tablets, USP, 25mg recalled by The Harvard Drug Group	The Harvard Drug Group	Potency & Assay	Nationwide
10 Jul 2024Drug	CLASS II	Venlafaxine Hydrochloride, extended-release capsules recalled	The Harvard Drug Group	Potency & Assay	Nationwide
21 Feb 2024Drug	CLASS II	HydrALAZINE Hydrochloride Tablets, USP 10mg recalled	The Harvard Drug Group	Potency & Assay	Nationwide
27 Dec 2023Drug	CLASS I	Phenytoin Oral Suspension, USP, 100 mg recalled	The Harvard Drug Group	Packaging Defects	Nationwide
29 Nov 2023Drug	CLASS I	Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3% recalled	The Harvard Drug Group	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.