CLASS II ONGOING Drug recall · Reported 12 Feb 2025 · FDA Enforcement Report
HydrALAZINE Hydrochloride , USP, 50mg recalled by Sky Packaging
Sky Packaging is recalling HydrALAZINE Hydrochloride , USP, 50mg, distributed nationwide in the US. The recall was initiated on 24 Jan 2025 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-0220-2025
- FDA event ID
- 96159
- Recalling firm
- Sky Packaging, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jan 2025
- FDA classified
- 4 Feb 2025
- Reported
- 12 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 24 Jan 2025 | Recall initiated by company | |
| 4 Feb 2025 | Classified by FDA | +11 days |
| 12 Feb 2025 | Published in enforcement report | +8 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
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 Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-328-10
Where it was distributed
Nationwide within the United States
Questions about this recall
Is HydrALAZINE Hydrochloride , USP, 50mg recalled?
Yes. Sky Packaging recalled HydrALAZINE Hydrochloride , USP, 50mg on 24 Jan 2025. The recall is Class II and its status is Ongoing. Recall number D-0220-2025.
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot #: 0000127410, 63739-328-10, Exp. Date 30-Apr-2025; 0000127579, Exp. Date 31-Aug-2025; 0000128245, Exp. Date 31-Dec-2025; 0000128486, Exp. Date 28-Feb-2026.
Where was it sold?
Nationwide within the United States
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 21 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 Sky Packaging
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | HydrALAZINE Hydrochloride recalled by Sky Packaging | Sky Packaging | Potency & Assay | Nationwide |