Why it was recalled
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Product description
HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01.
Lot numbers, UPCs & expiration codes
104024120001, Exp Date 06/01/2025; 104024120002, Exp Date 06/21/2025; 104025010001, Exp Date 07/13/2025; 104025010002, Exp Date 07/28/2025
Where it was sold
Nationwide in the USA
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-0385-2025
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 15, 2025
- FDA report date
- Apr 30, 2025
- Quantity
- 1,375 cassettes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- OurPharma LLC
Original FDA data
Every field from FDA enforcement report D-0385-2025, exactly as published.
Show all FDA fields
- City
- Fayetteville
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 96706
- Address
- 2512 S City Lake Rd
- Code information
- 104024120001, Exp Date 06/01/2025; 104024120002, Exp Date 06/21/2025; 104025010001, Exp Date 07/13/2025; 104025010002, Exp Date 07/28/2025
- Postal code
- 72701-5013
- Report date
- Apr 30, 2025
- Product type
- Drugs
- Recall number
- D-0385-2025
- Classification
- Class III
- Recalling firm
- OurPharma LLC
- Product quantity
- 1,375 cassettes
- Termination date
- Mar 6, 2026
- Reason for recall
- Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 15, 2025
- Initial firm notification
- Letter
- Center classification date
- Apr 21, 2025