UnratedDrug recall · FDA · Published February 24, 2022
HydrALAZINE HCl Tablets Recall: Impurities Risk in Routine Testing
The Harvard Drug Group recalls 10 mg hydrALAZINE HCl tablets due to impurities found in stability testing. This affects specific lots from March 2023. No remedy is stated in the recall notice.
“HydrALAZINE HCl Tablets Recall: Impurities Risk in Routine Testing.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35207-hydralazine-hcl-tablets-recall-impurities-risk-in-routine-testing. Based on FDA recall #D-0653-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0653-2022%22&limit=1).
The Food and Drug Administration announced on Feb. 24, 2022, that The Harvard Drug Group voluntarily recalled hydrALAZINE HCl Tablets, USP, 10 mg due to failed impurity specifications. The recall affects 5,953 cartons distributed nationwide.
How to tell if you have it
Brand: The Harvard Drug Group
Product: hydrALAZINE HCl Tablets, USP, 10 mg
Packaging: 100 Tablets per carton (10x10 blister packs)
NDC: 0904-6440-61
Lot codes: T03755, T03756
Expiration date: 03/2023
Distributor: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA
The hazard
The recall was issued because an out-of-specification result was obtained during routine stability testing for impurities. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show The Harvard Drug Group has 20 other recalls on record since July 15, 2016. Other recent recalls of similar products include Harvard Drug Group Recalls Tramadol Tablets Due to Packaging Defect (June 16, 2023), Harvard Drug Group Recalls Gabapentin Tablets Due to Foreign Tablet Mixup (April 24, 2023), and Carbidopa Levodopa Tablets Recall: Blister Packaging Defect (Feb. 23, 2023). Other recent recalls of similar products include Ajanta Pharma Fluphenazine Tablets Recall: Impurity Risk in 100-Count Bottles (Aug. 25, 2026), Hikma Ramipril Capsules 10mg Recall: Impurity Risk (Aug. 24, 2026), and Macleods Olanzapine Tablets 5mg Recall: Impurities May Cause Harm (Aug. 27, 2026).
How to tell if you have this one
Check for the lot numbers T03755 or T03756 on the packaging. The tablets are 10 mg, 100 per carton (10x10 blister packs), and expire by March 2023.
Brand
The Harvard Drug Group
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Packaging
Look for lot numbers T03755 or T03756 on the packaging of hydrALAZINE HCl tablets.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0653-2022 (February 24, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0653-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.