Pharmakon Recalls Hydromorphone Syringes Due to Stability Data Issues
Pharmakon Pharmaceuticals is recalling 8,000 units of Hydromorphone HCl 1 mg/mL syringes nationwide because stability data does not support the expiration dates.
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 agency classified this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving injectable medications where stability issues could lead to adverse health consequences.
Plain-English summary
Pharmakon Pharmaceuticals is recalling 8,000 units of Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes. The recall covers all lots with expiration dates up to 11/17/2015 and was distributed nationwide.
The recall was initiated because stability data does not support the expiration dates for the product. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected syringes and contact Pharmakon Pharmaceuticals or their supplier for further instructions on returns or replacements.
The recalled product
- Product
- Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable
- Affected units
- 8,000
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 (1)
- All lots with expiration dates up to 11/17/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Pharmakon Pharmaceuticals 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 22 products in this recall →Related recalls
Same manufacturer · Pharmakon Pharmaceuticals
See all →- CriticalPharmakon Recalls Morphine Sulfate Syringes Due to High Potency
FDA (Drugs) · 2016-06-01
- ModeratePharmakon Recalls Midazolam Syringes Due to Insufficient Stability Data
FDA (Drugs) · 2016-02-03
- ModeratePharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Issues
FDA (Drugs) · 2016-02-03
- ModeratePharmakon Recalls Ketamine Syringes Due to Insufficient Stability Data
FDA (Drugs) · 2016-02-03
- ModeratePharmakon Recalls Provocholine Pre-diluted Sets Due to Stability Data Concerns
FDA (Drugs) · 2016-02-03
Same hazard · stability issue
See all →- Moderate5-PLASMA Bivalirudin Control Model 5D-44905 Recalled Due to Stability Issues
FDA (Devices) · 2026-08-12
- ModerateAniara 5-PLASMA Bivalirudin Calibrator Recalled for Stability Issues
FDA (Devices) · 2026-08-12
- HighInjectable Drug Recalled for Stability Issues at Expiration
FDA (Drugs) · 2025-03-26
- ModerateMedline Bleach Germicidal Wipes Recalled for Incorrect Shelf-Life Labeling
FDA (Devices) · 2024-02-28
- ModerateZydus oxybutynin extended-release tablets recalled nationwide for failed stability testing
FDA (Drugs) · 2023-11-15
Similar recalls
- ModeratePharmedium Recalls Hydromorphone Syringes Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19
- SeverePharmakon Recalls Hydromorphone Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SeverePharmakon Recalls Hydromorphone Injection Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SeverePharmedium Recalls Lidocaine Syringes Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19
- SeverePharMEDium Recalls Hydromorphone Syringes Due to Potency Issues
FDA (Drugs) · 2018-06-20
- SeverePharmedium Recalls Methadone Syringes Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19