HydrALAZINE Hydrochloride Tablets recall
FDA recall D-0324-2024 · initiated Feb 9, 2024
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled HydrALAZINE Hydrochloride Tablets in Feb 2024 — an FDA Class II recall (D-0324-2024) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was 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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 8,198 units
Details
- Product
- 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
- Recalling company
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- The product was distributed nationwide within the United States.
- Initiated
- Feb 9, 2024
- FDA report date
- Feb 21, 2024
Frequently asked
- Was HydrALAZINE Hydrochloride Tablets recalled?
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled HydrALAZINE Hydrochloride Tablets in Feb 2024 — an FDA Class II recall (D-0324-2024) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was HydrALAZINE Hydrochloride Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0324-2024 was: 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.
- Is a recalled HydrALAZINE Hydrochloride Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of HydrALAZINE Hydrochloride Tablets are affected?
- Distributed: The product was distributed nationwide within the United States.. The recall covers these lots — Lot #: T04680, Exp. Date 6/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0324-2024.