CLASS III Drug recall · Reported 18 Jul 2012 · FDA Enforcement Report

Hydrocortisone and Acetic Acid Otic Solution recalled

Vintage Pharmaceuticals is recalling Hydrocortisone and Acetic Acid Otic Solution, USP, distributed nationwide in the US. The recall was initiated on 6 Jul 2012 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: L072B11A, Exp 8/12; L102C11A, L103C11A, Exp 10/12; L046D11A, L082F11A, L089F11A, Exp 11/12; L148J11A, L149J11A, L150J11A, Exp 03/13; and L151J11A, Exp 04/13

Quantity recalled54,431 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-1411-2012
FDA event ID: 62496
Recalling firm: Vintage Pharmaceuticals, Huntsville, AL
Classification: Class III
Status: Terminated
Recall initiated: 6 Jul 2012
FDA classified: 11 Jul 2012
Reported: 18 Jul 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Creams, Ointments & Gels

Timeline

6 Jul 2012	Recall initiated by company
11 Jul 2012	Classified by FDA	+5 days
18 Jul 2012	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

Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.

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

HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.

Where it was distributed

Nationwide and Puerto Rico.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.

Which lots are affected?

Lot #: L072B11A, Exp 8/12; L102C11A, L103C11A, Exp 10/12; L046D11A, L082F11A, L089F11A, Exp 11/12; L148J11A, L149J11A, L150J11A, Exp 03/13; and L151J11A, Exp 04/13

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 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 Vintage Pharmaceuticals

All 7

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1 Feb 2017Drug	CLASS III	Dexamethasone Elixir, USP, 0.5 mg recalled by Vintage Pharmaceuticals	Vintage Pharmaceuticals	Potency & Assay	Nationwide
9 Sep 2015Drug	CLASS II	Lisinopril Tablets, USP, 40 mg, a) bottle recalled	Vintage Pharmaceuticals	Potency & Assay	Nationwide
6 Feb 2013Drug	CLASS I	Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg recalled	Vintage Pharmaceuticals	Potency & Assay	Nationwide
28 Nov 2012Drug	CLASS I	Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg recalled	Vintage Pharmaceuticals	Potency & Assay	Nationwide
31 Oct 2012Drug	CLASS II	Perphenazine Tablets recalled by Vintage Pharmaceuticals	Vintage Pharmaceuticals	Other	Nationwide

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All 24

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28 May 2025Drug	CLASS II	Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream recalledRapidol	Kenil Healthcare Private	Manufacturing (CGMP) Deviations	DE, NC
15 Nov 2023Drug	CLASS III	Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP dropper recalledHydrocortisone And Acetic Acid	Taro Pharmaceuticals	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Hydrocortisone and Acetic Acid Otic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
15 Jun 2022Drug	CLASS II	Hydrocortisone Ointment recalled by Mckesson Medical-SurgicalHydrocortisone	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
2 Jun 2021Drug	CLASS II	Hydrocortisone Acet 30mg recalled by Cardinal HealthHydrocortisone Acetate	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC