HydrALAZINE Hydrochloride recall
FDA recall D-0219-2025 · initiated Jan 24, 2025
SKY PACKAGING recalled HydrALAZINE Hydrochloride in Jan 2025 — an FDA Class II recall (D-0219-2025) because Failed Impurities/Degradation Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
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.
Details
- Product
- HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10
- Recalling company
- SKY PACKAGING
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Jan 24, 2025
- FDA report date
- Feb 12, 2025
Frequently asked
- Was HydrALAZINE Hydrochloride recalled?
- SKY PACKAGING recalled HydrALAZINE Hydrochloride in Jan 2025 — an FDA Class II recall (D-0219-2025) because Failed Impurities/Degradation Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was HydrALAZINE Hydrochloride recalled?
- Per the FDA enforcement record, the reason for recall D-0219-2025 was: Failed Impurities/Degradation Specifications
- Is a recalled HydrALAZINE Hydrochloride 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 are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 0000127312, Exp. Date 31-Mar-2025; 0000127576, 0000127577, Exp. Date 31-Jul-2025; 0000128204, Exp. Date 31-Dec-2025; 0000128358, Exp. Date 31-Jan-2026. 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-0219-2025.