FDA Recall of Epinephrine Injection Over Sterility Concerns
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
The FDA has announced a recall of 81,520 units of Epinephrine Injection due to a lack of assurance of sterility, affecting products distributed nationwide.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 3, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
The recall was initiated because of a lack of assurance of sterility in the affected epinephrine injection products.
Which Products Are Affected
The affected products are EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, manufactured by International Medication Systems, Limited. The specific details include NDC 76329-3318-1, lot number EA038A5, expiration date 08/2026, and a total of 81,520 units. These products were distributed U.S. nationwide.
What You Should Do
Consumers should contact the recalling firm, International Medication Systems Ltd., for instructions as the recall was initiated via letter.
Why This Matters
This recall addresses potential risks associated with non-sterile injectable drugs, which could impact patient safety in medical settings.
Source
Attribution: FDA Recall Number D-0483-2026. For more information, visit the FDA website.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (899 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to May 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.