CLASS II Drug recall · Reported 3 May 2017 · FDA Enforcement Report

Methylprednisolone Acetate 40 mg/mL recalled

Isomeric Pharmacy Solution is recalling Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL Multi-Dose Vial For Injection, distributed nationwide in the US. The recall was initiated on 6 Apr 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #s: 09007, Exp 04/04/17; 09016, Exp 04/16/17; 09020, Exp 04/18/17; 09025, Exp 04/23/17; 10026, 10030, Exp 05/28/17; 11007, Exp 05/30/17; 11008, Exp 05/31/17; 11020, Exp 06/07/17; 11028, Exp 06/12/17; 11043, Exp 06/26/17.

Quantity recalled4,001 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-0681-2017
FDA event ID: 76951
Recalling firm: Isomeric Pharmacy Solution, Salt Lake City, UT
Classification: Class II
Status: Terminated
Recall initiated: 6 Apr 2017
FDA classified: 26 Apr 2017
Reported: 3 May 2017
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Drug class: Pain Medication

Timeline

6 Apr 2017	Recall initiated by company
26 Apr 2017	Classified by FDA	+20 days
3 May 2017	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

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1010, barcode 3 70285 10101 4.

Where it was distributed

Nationwide in the USA and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Which lots are affected?

Lot #s: 09007, Exp 04/04/17; 09016, Exp 04/16/17; 09020, Exp 04/18/17; 09025, Exp 04/23/17; 10026, 10030, Exp 05/28/17; 11007, Exp 05/30/17; 11008, Exp 05/31/17; 11020, Exp 06/07/17; 11028, Exp 06/12/17; 11043, Exp 06/26/17.

Where was it sold?

Nationwide in the USA and Puerto Rico

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

6 other products · FDA event 76951

This product is part of a recall event; the main page for the event is Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol recalled.

Reported	Class	Recall	Company	Reason	Where
3 May 2017	CLASS II	Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol recalled	Isomeric Pharmacy Solution	Sterility	Nationwide
3 May 2017	CLASS II	Triamcinolone Diacetate 40 mg/mL Multi-Dose Vial For Injection recalled	Isomeric Pharmacy Solution	Sterility	Nationwide
3 May 2017	CLASS II	Testosterone Cypionate 200 mg/mL recalled by Isomeric Pharmacy Solution	Isomeric Pharmacy Solution	Sterility	Nationwide
3 May 2017	CLASS II	Triamcinolone Acetonide 40 mg/mL recalled by Isomeric Pharmacy Solution	Isomeric Pharmacy Solution	Sterility	Nationwide
3 May 2017	CLASS II	Phenylephrine 2.5%, Tropicamide 1% Multi-Dose Ophthalmic recalled	Isomeric Pharmacy Solution	Sterility	Nationwide
3 May 2017	CLASS II	Methylprednisolone Acetate 80 mg/mL recalled	Isomeric Pharmacy Solution	Sterility	Nationwide

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	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
3 May 2017Drug	CLASS II	Triamcinolone Diacetate 40 mg/mL Multi-Dose Vial For Injection recalled	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