Why it was recalled
Failed Impurities/Degradation Specifications
Product description
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
Lot numbers, UPCs & expiration codes
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 it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0220-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 24, 2025
- FDA report date
- Feb 12, 2025
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SKY PACKAGING
Original FDA data
Every field from FDA enforcement report D-0220-2025, exactly as published.
Show all FDA fields
- City
- Memphis
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 96159
- Address
- 4835 Crumpler Rd Ste B
- Code information
- 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.
- Postal code
- 38141
- Report date
- Feb 12, 2025
- Product type
- Drugs
- Recall number
- D-0220-2025
- Classification
- Class II
- Recalling firm
- SKY PACKAGING
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jan 24, 2025
- Initial firm notification
- Telephone
- Center classification date
- Feb 4, 2025