CLASS II Drug recall · Reported 13 May 2020 · FDA Enforcement Report
Epinephrine Injection USP, 0.3 mg (Auto-Injector) recalled
Teva Pharmaceuticals USA is recalling Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ pre-filled syringe. The recall was initiated on 5 Mar 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1260-2020
- FDA event ID
- 85146
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Brand
- Epinephrine
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Mar 2020
- FDA classified
- 5 May 2020
- Reported
- 13 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Allergy Medication
Timeline
| 5 Mar 2020 | Recall initiated by company | |
| 5 May 2020 | Classified by FDA | +61 days |
| 13 May 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
Product as listed by the FDA
Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27
Where it was distributed
Product was distributed to 1 wholesaler who still had all units within their possession and had not shipped or further distributed any of the product.
Questions about this recall
Why was it recalled?
CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
Which lots are affected?
Lot # 007F19AA, exp. date 04/2021
Where was it sold?
Product was distributed to 1 wholesaler who still had all units within their possession and had not shipped or further distributed any of the product.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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Other Epinephrine recalls
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Epinephrine Injection, USP, 30 mg/ (1mg/mL)-Multiple-Dose Vial recalledEpinephrine | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS III | Epinephrine Injection, USP, 1mg/mL single-dose vial recalledEpinephrine | Fresenius Kabi USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Epinephrine Injection, USP, 1 mg/ (0.1 mg/mL) recalledEpinephrine | International Medication Systems | Sterility | Nationwide |
| Drug | CLASS II | Adrenalin (epinephrine) Injection 1mg/mL single dose vial recalledAdrenalin | Henry Schein Inc. and Glove Club HSI Gloves | Packaging Defects | Nationwide |
| Drug | CLASS II | EPINEPHrine, 2 mg added to dextrose 5%, Concentration = 8 mcg/mL, IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |