CLASS II Drug recall · Reported 19 Oct 2016 · FDA Enforcement Report
lidocaine HCl, 2%, 40 mg per Total Volume in a syringe recalled
Pharmedium Services is recalling lidocaine HCl, 2%, 40 mg per Total Volume in a syringe, distributed nationwide in the US. The recall was initiated on 17 Jul 2015 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-0065-2017
- FDA event ID
- 73925
- Recalling firm
- Pharmedium Services, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jul 2015
- FDA classified
- 12 Oct 2016
- Reported
- 19 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 17 Jul 2015 | Recall initiated by company | |
| 12 Oct 2016 | Classified by FDA | +453 days |
| 19 Oct 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
lidocaine HCl, 2%, 40 mg per 2 mL, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3112.
Where it was distributed
Nationwide
Questions about this recall
Is lidocaine HCl, 2%, 40 mg per Total Volume in a syringe recalled?
Yes. Pharmedium Services recalled lidocaine HCl, 2%, 40 mg per Total Volume in a syringe on 17 Jul 2015. The recall is Class II and its status is Terminated. Recall number D-0065-2017.
Why was it recalled?
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Which lots are affected?
Lot Numbers: 15118067M, 15120045M, 15127005M, 15131002M, 15135005M, 15135046M, 15140001M, 15140045M, 15146007M, 15147070M, 15152052M, 151880331M, 151900241M, Exp between 07/15/15-10/12/15
Where was it sold?
Nationwide
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 21 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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|---|---|---|---|---|---|
| Drug | CLASS II | rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |
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| Drug | CLASS II | nICARdipine HCl 1 mg/mL) 1 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | rocuronium Bromide 10 mg per mL 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |