IMS epinephrine injection vials recalled over lack of sterility assurance
International Medication Systems is recalling one lot of Epinephrine Injection, USP, 1 mg/10 mL, citing lack of assurance of sterility. 81,520 units are affected.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a sterile injectable where sterility cannot be assured, a risk of harm with no injuries reported in the source.
Plain-English summary
International Medication Systems, Limited, an Amphastar Pharmaceuticals company, is recalling Epinephrine Injection, USP, 1 mg/10 mL (0.1 mg/mL), NDC 76329-3318-1. The action covers 81,520 units.
The stated reason is lack of assurance of sterility. Sterility is a defining requirement of an injectable product because it is introduced directly into the bloodstream or tissue. The FDA classified the action as Class II.
The affected lot is EA038A5, expiry 08/2026. Distribution was US nationwide.
This is a prescription product supplied to healthcare facilities, including for emergency use. Facilities should check stock against the lot number above, quarantine affected units and follow the instructions issued by the manufacturer.
The recalled product
- Product
- EPINEPHRINE (EPINEPHRINE)
- Brand
- EPINEPHRINE
- Manufacturer
- International Medication Systems Ltd.
- Category
- Drug — Injectable emergency drug
- Affected units
- 81,520
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 (2)
- Lot Number: EA038A5
- Expiration Date: 08/2026.
Distribution
Distributed nationwide across the United States.
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