FDA Recalls Hydromorphone Intrathecal Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Hydromorphone 1 mg/ml Intrathecal Solution because FDA inspections found GMP violations that may affect sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a sterile injectable product where sterility assurance is compromised, posing a significant risk of serious injury or death from infection.
Plain-English summary
The Compounding Pharmacy of America is recalling Hydromorphone 1 mg/ml Intrathecal Solution, Sterile-Preservative Free. The recall involves 22 ml vials distributed nationwide between November 2014 and May 2015. Specific lot codes include 04272015@22, with a date of 7/26/2015.
The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the quality and sterility of the product, meaning there is a lack of assurance that the solution is sterile.
Patients and healthcare providers who have received this product should contact their healthcare provider for further instructions. The recall is classified as FDA Class II.
The recalled product
- Product
- Hydromorphone 1 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All lots distributed between November 2014 and May 2015
- 04272015@22
- 7/26/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 382 recalled by The Compounding Pharmacy of America under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 382 products in this recall →Related recalls
Same manufacturer · The Compounding Pharmacy of America
See all →- CriticalFDA Recalls Non-Sterile HCG and Methylcobalamin Injection Vials
FDA (Drugs) · 2018-02-21
- SevereFDA Recalls Morphine and Ropivacaine Compounded Solution Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereHydromorphone Solution Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereMorphine and Bupivacaine Solution Recalled for Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereMethylcobalamin Injectable Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
Same hazard · sterility
See all →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- HighFDA Recalls Hydromorphone Injectable Solution Due to Sterility Validation Failure
FDA (Drugs) · 2023-08-09
- SeverePharmedium Recalls Hydromorphone HCl Injection Due to Sterility Concerns
FDA (Drugs) · 2018-02-28
- SevereUS Compounding Recalls Morphine PF Vials Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- SevereFDA Recalls Hydromorphone Sterile Drug Preparations for Lack of Sterility Assurance
FDA (Drugs) · 2018-02-14
- SeverePharmakon Recalls Hydromorphone Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SevereAssurance Infusion Recalls Hydromorphone Injection Due to Sterility Concerns
FDA (Drugs) · 2020-01-22