CLASS II Drug recall · Reported 23 Mar 2022 · FDA Enforcement Report
hydrALAZINE HCl Tablets, USP, 10 mg per carton ( blister packs) recalled
The Harvard Drug Group is recalling hydrALAZINE HCl Tablets, USP, 10 mg per carton ( blister packs), distributed nationwide in the US. The recall was initiated on 24 Feb 2022 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-0653-2022
- FDA event ID
- 89663
- Recalling firm
- The Harvard Drug Group, Livonia, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Feb 2022
- FDA classified
- 14 Mar 2022
- Reported
- 23 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 24 Feb 2022 | Recall initiated by company | |
| 14 Mar 2022 | Classified by FDA | +18 days |
| 23 Mar 2022 | Published in enforcement report | +9 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: Out of specification result obtained 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, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
Where it was distributed
Nationwide within USA
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Which lots are affected?
Lot #: T03755, T03756, Exp. Date 03/2023
Where was it sold?
Nationwide within USA
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 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 |