CLASS II Drug recall · Reported 3 Feb 2016 · FDA Enforcement Report
Lidocaine HCI (PF) Inj, USP 2%, injectable recalled
Pharmakon Pharmaceuticals is recalling Lidocaine HCI (PF) Inj, USP 2%, injectable, distributed nationwide in the US. The recall was initiated on 19 Aug 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-0604-2016
- FDA event ID
- 72177
- Recalling firm
- Pharmakon Pharmaceuticals, Noblesville, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Aug 2015
- FDA classified
- 27 Jan 2016
- Reported
- 3 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 19 Aug 2015 | Recall initiated by company | |
| 27 Jan 2016 | Classified by FDA | +161 days |
| 3 Feb 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.
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 HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Stability data does not support expiry.
Which lots are affected?
All lots with expiration dates up to 11/17/2015
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 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.
Other products in this recall event
21 other products · FDA event 72177This product is part of a recall event; the main page for the event is Provocholine Pre-diluted Set II in 0.9% Sodium Chloride recalled.
More recalls from Pharmakon Pharmaceuticals
All 116| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Succinylcholine Chloride 20 mg/mL BD syringe recalled | Pharmakon Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Ketamine 20 mg/mL in 0.9% Sodium Chloride lntravia recalled | Pharmakon Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride fill recalled | Pharmakon Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Ketamine 50mg/mL in 0.9% Sodium Chloride fill in syringe recalled | Pharmakon Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Cefazolin 2GM added to 5% Dextrose recalled by Pharmakon Pharmaceuticals | Pharmakon Pharmaceuticals | Sterility | Nationwide |