CLASS III Drug recall · Reported 20 Nov 2024 · FDA Enforcement Report
Hydralazine HCl Tablets, USP, 25mg recalled by The Harvard Drug Group
The Harvard Drug Group is recalling Hydralazine HCl Tablets, USP, 25mg, distributed nationwide in the US. The recall was initiated on 5 Nov 2024 and the FDA has classified it as Class III.
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-0045-2025
- FDA event ID
- 95700
- Recalling firm
- The Harvard Drug Group, La Vergne, TN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Nov 2024
- FDA classified
- 14 Nov 2024
- Reported
- 20 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 5 Nov 2024 | Recall initiated by company | |
| 14 Nov 2024 | Classified by FDA | +9 days |
| 20 Nov 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
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 HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.
Where it was distributed
Nationwide in the US.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Which lots are affected?
Lot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025
Where was it sold?
Nationwide in the US.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 II | HydrALAZINE Hydrochloride Tablets, USP 10mg recalled | 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 |