Cantrell Drug Recalls Hydromorphone Syringes Due to Sterility Concerns
Cantrell Drug Company is recalling 935 vials of Hydromorphone HCl 50 mg/50 mL single-dose syringes due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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 lack of assurance of sterility in a sterile drug product, which meets the rubric criteria for a Severe rating.
Plain-English summary
Cantrell Drug Company is recalling 935 single-dose syringes of Hydromorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL). The product is identified by NDC 52533-006-04, Lot 9016, and a beyond-use date of March 7, 2017.
The recall was initiated because the firm lacks assurance of the sterility of the affected drug products. The recall is classified as Class II by the U.S. Food and Drug Administration.
The affected syringes were distributed nationwide. Patients and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-04
- Manufacturer
- Cantrell Drug Company
- Category
- Drug — Sterile Injectable
- Hazard
- Affected units
- 935
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)
- Lot: 9016 BUD: 3/7/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 21 recalled by Cantrell Drug Company 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 21 products in this recall →Related recalls
Same manufacturer · Cantrell Drug Company
See all →- SevereCantrell Drug Company Recalls Rocuronium Bromide Injection Due to Sterility Concerns
FDA (Drugs) · 2017-08-16
- SevereCantrell Drug Recalls Succinylcholine Chloride Injection Due to Sterility Concerns
FDA (Drugs) · 2017-08-16
- SevereCantrell Drug Recalls Norepinephrine Bags Due to Sterility Concerns
FDA (Drugs) · 2017-08-16
- SevereCantrell Recalls Neostigmine Methylsulfate Injection Due to Sterility Concerns
FDA (Drugs) · 2017-08-16
- SevereCantrell Drug Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2017-08-16
Same hazard · sterility failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22