CLASS II Drug recall · Reported 21 Feb 2024 · FDA Enforcement Report
HydrALAZINE Hydrochloride Tablets, USP 10mg recalled
The Harvard Drug Group is recalling HydrALAZINE Hydrochloride Tablets, USP 10mg, distributed nationwide in the US. The recall was initiated on 9 Feb 2024 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-0324-2024
- FDA event ID
- 93929
- Recalling firm
- The Harvard Drug Group, La Vergne, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Feb 2024
- FDA classified
- 13 Feb 2024
- Reported
- 21 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 9 Feb 2024 | Recall initiated by company | |
| 13 Feb 2024 | Classified by FDA | +4 days |
| 21 Feb 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
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
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
Where it was distributed
The product was distributed nationwide within the United States.
Questions about this recall
Why was it recalled?
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Which lots are affected?
Lot #: T04680, Exp. Date 6/2024
Where was it sold?
The product was distributed nationwide within the United States.
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) recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
Other Hydralazine recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | HydrALAZINE Hydrochloride recalled by Sky Packaging | SKY Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | HydrALAZINE Hydrochloride , USP, 50mg recalled by Sky Packaging | SKY Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Hydralazine HCl Tablets, USP, 25mg recalled by The Harvard Drug Group | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS III | HydrALAZINE Hydrochloride Tablets, USP, 10 mg (10 x per unit dose recalled | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | HydrALAZINE Hydrochloride Tablets, USP, 25 mg recalled | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |