CLASS III Drug recall · Reported 28 Mar 2018 · FDA Enforcement Report

Triamcinolone Acetonide Lotion recalled by Akorn

Akorn is recalling Triamcinolone Acetonide Lotion, USP 0.1%, distributed nationwide in the US. The recall was initiated on 9 Mar 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot# 2062900, Exp 05/18

Quantity recalled4,128 bottles

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-0617-2018
FDA event ID: 79466
Recalling firm: Akorn, Lake Forest, IL
Classification: Class III
Status: Terminated
Recall initiated: 9 Mar 2018
FDA classified: 3 Apr 2018
Reported: 28 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Creams, Ointments & Gels

Timeline

9 Mar 2018	Recall initiated by company
28 Mar 2018	Published in enforcement report	+19 days
3 Apr 2018	Classified by FDA	+6 days

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

Reason for recall

Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

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

Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.

Where it was distributed

Nationwide in the USA and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

Which lots are affected?

Lot# 2062900, Exp 05/18

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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.

More recalls from Akorn

All 192

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Timolol Maleate Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Calcipotriene Topical Solution, 0.005% (Scalp Solution) recalled	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Lidocaine Ointment USP, 5%, 1 tubes recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Midazolam Injection, USP 2mg recalled by Akorn	Akorn	Potency & Assay	Nationwide

Other Triamcinolone Acetonide recalls

All 26

Reported	Class	Recall	Company	Reason	Where
27 Nov 2024Drug	CLASS III	Triamcinolone Acetonide Cream recalled by Padagis US	Padagis US	Potency & Assay	Nationwide
3 Jul 2024Drug	CLASS II	Zilretta (triamcinolone acetonide extended-release recalledZilretta	Pacira Pharmaceuticals	Potency & Assay	Nationwide
19 Jun 2024Drug	CLASS II	Drug Vial Label: Zilretta¿ recalled by Pacira PharmaceuticalsZilretta	Pacira Pharmaceuticals	Potency & Assay	Nationwide
11 Oct 2023Drug	CLASS II	Triamcinolone Acetonide Injectable Suspension recalled by Eugia USTriamcinolone Acetonide	Eugia US	Particulate Matter	Nationwide
21 Sep 2022Drug	CLASS II	Triamcinolone Acetonide cream, 0.1% tube recalled by Direct RxTriamcinolone Acetonide	Direct Rx	Manufacturing (CGMP) Deviations	GA, ID