CLASS II Drug recall · Reported 14 Sep 2016 · FDA Enforcement Report

Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL recalled

Isomeric Pharmacy Solution is recalling Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection multidose vial, sterile, distributed nationwide in the US. The recall was initiated on 29 Jun 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots# 03045 and 03046; Exp. 10/16

Quantity recalled274 multdose vials

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-1480-2016
FDA event ID: 74603
Recalling firm: Isomeric Pharmacy Solution, Salt Lake City, UT
Classification: Class II
Status: Terminated
Recall initiated: 29 Jun 2016
FDA classified: 2 Sep 2016
Reported: 14 Sep 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Drug class: Pain Medication

Timeline

29 Jun 2016	Recall initiated by company
2 Sep 2016	Classified by FDA	+65 days
14 Sep 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.

Product as listed by the FDA

Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109,

Where it was distributed

Nationwide and Puerto Rico. No Canadian, other foreign, govt/VA/military consignees.

Nationwide Puerto Rico Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Lots# 03045 and 03046; Exp. 10/16

Where was it sold?

Nationwide and Puerto Rico. No Canadian, other foreign, govt/VA/military consignees.

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.

Reported	Class	Recall	Company	Reason	Where
3 May 2017Drug	CLASS II	Methylprednisolone Acetate 80 mg/mL recalled	Isomeric Pharmacy Solution	Sterility	Nationwide
3 May 2017Drug	CLASS II	Phenylephrine 2.5%, Tropicamide 1% Multi-Dose Ophthalmic recalled	Isomeric Pharmacy Solution	Sterility	Nationwide
3 May 2017Drug	CLASS II	Methylprednisolone Acetate 40 mg/mL recalled	Isomeric Pharmacy Solution	Sterility	Nationwide
3 May 2017Drug	CLASS II	Triamcinolone Acetonide 40 mg/mL recalled by Isomeric Pharmacy Solution	Isomeric Pharmacy Solution	Sterility	Nationwide
3 May 2017Drug	CLASS II	Testosterone Cypionate 200 mg/mL recalled by Isomeric Pharmacy Solution	Isomeric Pharmacy Solution	Sterility	Nationwide

Other Methylprednisolone recalls

All 69

Reported	Class	Recall	Company	Reason	Where
4 Feb 2026Drug	CLASS II	methylprednisolone tablets, USP Dosepak, 4 mg recalled by GreenstoneMethylprednisolone	Greenstone	Other	Nationwide
22 May 2024Drug	CLASS II	MethylPREDNISolone Acetate Injectable Suspension recalledMethylprednisolone Acetate	Sagent Pharmaceuticals	Particulate Matter	Nationwide
13 Mar 2024Drug	CLASS II	Methylprednisolone acetate Injectable Suspension recalled by Eugia USMethylprednisolone Acetate	Eugia US	Potency & Assay	4 states
31 May 2023Drug	CLASS III	Methylprednisolone Acetate Injectable Suspension recalled	Amneal Pharmaceuticals of New York	Packaging Defects	Nationwide
22 Feb 2023Drug	CLASS II	Methylprednisolone 12MG IN NS Syringe, steroid recalled	Sentara Infusion Services	Sterility	Nationwide