Hartley Medical Center Pharmacy Recalls Morphine Sulfate Syringes Due to Sterility Concerns
Hartley Medical Center Pharmacy is recalling Morphine Sulfate 10 mg/ml syringes due to a lack of assurance of sterility. The product was distributed nationwide.
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. According to the rubric, FDA Class II recalls involving significant injury or hospitalization reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the text, the agency classification and the nature of the hazard (sterility of an injectable drug) align with the Severe criteria for Class II recalls where risk is significant.
Plain-English summary
Hartley Medical Center Pharmacy, Incorporated is recalling Morphine Sulfate 10 mg/ml, 20 ml syringes. The recall is being conducted because of a lack of assurance of sterility. The product is prescription-only and was distributed nationwide, with no foreign distribution reported.
The affected product has a best-use date of May 3, 2016. The recall is classified as Class II by the U.S. Food and Drug Administration. No specific lot numbers or quantities are provided in the source text.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Morphine Sulfate 10 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
- Manufacturer
- Hartley Medical Center Pharmacy, Incorporated
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1
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)
- BUD: 5/3/2016
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by Hartley Medical Center Pharmacy, Incorporated 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 30 products in this recall →Related recalls
Same manufacturer · Hartley Medical Center Pharmacy, Incorporated
See all →- SevereHartley Medical Center Pharmacy Recalls Sufentanil Citrate Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-03-16
- SevereHartley Medical Center Pharmacy Recalls Baclofen Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-03-16
- SevereHartley Medical Center Pharmacy Recalls Baclofen Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-03-16
- SevereMorphine Sulfate Syringes Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2016-03-16
- SevereHartley Medical Center Pharmacy Recalls Morphine and Bupivacaine Syringes
FDA (Drugs) · 2016-03-16
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
- SevereSCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2018-07-11
- SeverePharmakon Recalls Morphine Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SevereMorphine Sulfate Infusion Recall Due to Sterility Assurance Failure
FDA (Drugs) · 2022-03-23
- SevereAdvanced Pharma Recalls Morphine Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- HighMorphine Sulfate Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2022-07-27
- HighMartin Avenue Pharmacy Recalls Morphine Sulfate Syringes for Sterility Concerns
FDA (Drugs) · 2014-11-05