CLASS II Drug recall · Reported 10 Aug 2016 · FDA Enforcement Report

Betamethasone Acetate / Betamethasone Sodium Phosphate recalled

Isomeric Pharmacy Solution is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL, distributed nationwide in the US. The recall was initiated on 1 Aug 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot# 03037, Exp 8/17/16; 03042, 03043, Exp 8/31/16; 04043, Exp 9/29/16; 04047, 04048, Exp 10/1/16; 04052, 04053, Exp10/2/16; 05042, Exp 10/29/16; 05046, Exp 11/2/16; 05048, 05049, Exp 11/3/16; 05050 Exp 11/4/16

Quantity recalled2,331 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-1454-2016
FDA event ID: 74832
Recalling firm: Isomeric Pharmacy Solution, Salt Lake City, UT
Classification: Class II
Status: Terminated
Recall initiated: 1 Aug 2016
FDA classified: 4 Aug 2016
Reported: 10 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

1 Aug 2016	Recall initiated by company
4 Aug 2016	Classified by FDA	+3 days
10 Aug 2016	Published in enforcement report	+6 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 is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate 7 mg/mL INJ SUSP because of the potential of drug clumps in the vial of the sterile drug product and larger particle sizes.

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

Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for injection, Rx Only, Isomeric Pharmacy Solution, 2401 Foothill Dr., Salt Lake City, UT 84109

Where it was distributed

Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot# 03037, Exp 8/17/16; 03042, 03043, Exp 8/31/16; 04043, Exp 9/29/16; 04047, 04048, Exp 10/1/16; 04052, 04053, Exp10/2/16; 05042, Exp 10/29/16; 05046, Exp 11/2/16; 05048, 05049, Exp 11/3/16; 05050 Exp 11/4/16

Where was it sold?

Nationwide 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.

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 Betamethasone recalls

All 19

Reported	Class	Recall	Company	Reason	Where
11 Mar 2020Drug	CLASS II	Betamethasone Acetate/Betamethasone recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020Drug	CLASS II	Betamethasone Acetate/Betamethasone recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020Drug	CLASS II	Betamethasone Acetate/Betamethasone recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
17 Apr 2019Drug	CLASS I	Lidocaine HCl Injection, USP 1 % 50 mg/ (10 mg/mL) vial recalledMarbeta L Kit	Aurobindo Pharma USA	Particulate Matter	NC, NM
23 Sep 2015Drug	CLASS II	Betamethasone Sodium Phosphate 30 mg/ml Injectable recalled	The Compounding Pharmacy of America	Sterility	Nationwide