CLASS II Drug recall · Reported 8 May 2019 · FDA Enforcement Report
HYDROmorphone 20 mg/ Injectable Solution recalled by Advanced Pharma
Advanced Pharma is recalling HYDROmorphone 20 mg/ Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride, distributed nationwide in the US. The recall was initiated on 26 Apr 2019 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-1251-2019
- FDA event ID
- 82718
- Recalling firm
- Advanced Pharma, Houston, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Apr 2019
- FDA classified
- 29 Apr 2019
- Reported
- 8 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 26 Apr 2019 | Recall initiated by company | |
| 29 Apr 2019 | Classified by FDA | +3 days |
| 8 May 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sub-potency
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
HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded Drug, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC: 42852-221-10
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Sub-potency
Which lots are affected?
Lot: 01/14/19 0215 22110P Exp. 04/29/2019
Where was it sold?
Nationwide in the US
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 26 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 Advanced Pharma
All 99| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Neostigmine Methylsulfate Injection Solution 5 mg recalled | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride recalled | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride recalled | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | Heparin in 0.45% Sodium Chloride, QS, Injectable Solution recalled | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride recalled | Advanced Pharma | Sterility | Nationwide |
Other Hydromorphone recalls
All 155| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | HYDROmorphone Hydrochloride 50mg/ (1mg/mL) recalled by OurPharma | OurPharma | Potency & Assay | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 30 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 6 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 25 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 20 mg/ in 0.9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |