FDA Expands Class I Recall of Morphine and Dilaudid Syringes
Fresenius Kabi USA expands its recall of opioid syringes to 625,500 units nationwide due to a potency mix-up.
5 reports on this incident · first at Aug 28, 2026, 9:21 a.m. ET
This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.
We last searched for new coverage of this at Aug 28, 2026, 9:39 a.m. ET — checked 53 min ago.
Earlier reports
Aug 28, 2026, 9:56 a.m. ET
FDA Reclassifies Morphine and Dilaudid Syringe Recall as Class I
The U.S. Food and Drug Administration has changed the hazard classification for the ongoing recall of Morphine Sulfate Injection USP and Dilaudid syringes made by Fresenius Kabi USA, according to a report by Medical Daily. The recall, initiated August 4, 2026, was previously classified as Class II; it is now Class I, the agency's most serious designation, meaning the product can cause serious adverse health consequences or death.
The recall involves 625,500 syringes distributed nationwide to distributors and wholesalers. The hazard is that an unexpectedly potent opioid dose can slow breathing dangerously. No adverse events had been reported for the affected lot when the recall was announced, Medical Daily reported.
The agency instructs users to stop distributing, dispensing, or using the product immediately and to return all units. The recall status is ongoing.
Aug 28, 2026, 9:52 a.m. ET
FDA Reports Injuries in Ongoing Class I Recall of Morphine and Dilaudid Syringes
The U.S. Food and Drug Administration has received reports of injuries or illnesses in connection with the ongoing Class I recall of Morphine Sulfate Injection USP and Dilaudid syringes made by Fresenius Kabi USA, according to Medical Daily. The agency has not specified the nature or number of these events.
The recall, initiated August 4, 2026, involves 625,500 syringes distributed nationwide to distributors and wholesalers. The hazard is that an unexpectedly potent opioid dose can slow breathing dangerously. No adverse events had been reported for the affected lot when the recall was announced, Medical Daily reported.
The FDA has classified the recall as Class I, the most serious type. The agency instructs users to stop distributing, dispensing, or using the affected syringes immediately and to return all units. The recall is ongoing.
Aug 28, 2026, 9:23 a.m. ET
FDA Closes Class I Recall of Morphine and Dilaudid Syringes
The U.S. Food and Drug Administration has closed the Class I recall of Morphine Sulfate Injection USP and Dilaudid syringes distributed nationwide by Fresenius Kabi USA, according to Medical Daily. The agency considers the recall carried out.
The recall, initiated August 4, 2026, involved 625,500 syringes distributed to distributors and wholesalers nationwide. The hazard was that an unexpectedly potent opioid dose could slow breathing dangerously. No adverse events had been reported for the affected lot when the recall was announced.
The FDA advises anyone still holding the product to stop distributing, dispensing, or using it immediately and return all units.
Aug 28, 2026, 9:21 a.m. ETFirst report
FDA Class I Recall Issued for Morphine and Dilaudid Syringes
The U.S. Food and Drug Administration (FDA) has issued a Class I recall for certain lots of Morphine Sulfate Injection USP and Dilaudid syringes distributed nationwide by Fresenius Kabi USA, according to a report from Medical Daily. The recall, initiated on August 4, 2026, affects 625,500 syringes and is ongoing.
The hazard is that an unexpectedly potent opioid dose can slow breathing dangerously. The FDA advises stopping distribution, dispensing, or use immediately and returning all units. No adverse events had been reported for the affected lot when the recall was announced, Medical Daily reported.
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- Version 128 Aug 2026, 14:01current
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- Version 128 Aug 2026, 13:21current
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- Version 128 Aug 2026, 13:52current
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- Version 128 Aug 2026, 13:56current
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- Version 128 Aug 2026, 13:23current
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