CLASS III Drug recall · Reported 25 Jul 2012 · FDA Enforcement Report

Hydroxyzine Hydrochloride Oral Solution, USP, 10 mg/, 1 Pint recalled

Vintage Pharmaceuticals is recalling Hydroxyzine Hydrochloride Oral Solution, USP, 10 mg/, 1 Pint, 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 #s: L030F11A, L054F11A, Exp 05/13; L095E10A, Exp 06/13; L079J10A, L085K11A, L086K11A, L087G10A, L087K11A, L088K11A, Exp 10/13; L094L10A, Exp 12/13; and L100L10B, Exp 01/14

Quantity recalled73,746 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-1417-2012
FDA event ID: 62495
Recalling firm: Vintage Pharmaceuticals, Huntsville, AL
Classification: Class III
Status: Terminated
Recall initiated: 6 Jul 2012
FDA classified: 13 Jul 2012
Reported: 25 Jul 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Anxiety & Sleep Medication

Timeline

6 Jul 2012	Recall initiated by company
13 Jul 2012	Classified by FDA	+7 days
25 Jul 2012	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

Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-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

HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-1310-58, UPC 3 0603-1310-58 4.

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.

Which lots are affected?

Lot #s: L030F11A, L054F11A, Exp 05/13; L095E10A, Exp 06/13; L079J10A, L085K11A, L086K11A, L087G10A, L087K11A, L088K11A, Exp 10/13; L094L10A, Exp 12/13; and L100L10B, Exp 01/14

Where was it sold?

Nationwide

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

Reported	Class	Recall	Company	Reason	Where
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

Other Hydroxyzine recalls

All 16

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS III	hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/ (1 Pint) recalledHydroxyzine Hydrochloride	ANI Pharmaceuticals	Other	Nationwide
30 Dec 2020Drug	CLASS II	Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg recalled	Morton Grove Pharmaceuticals	Potency & Assay	Nationwide
31 Oct 2018Drug	CLASS II	HydrOXYzine Hydrochloride Syrup recalled by Lannett CompanyHydroxyzine Hydrochloride	Lannett	Potency & Assay	Nationwide
5 Oct 2016Drug	CLASS II	Hydroxyzine HCl, 50mg/ml Inj MDV, Rx, Vital Care Compounder recalled	Pharmacy Plus	Sterility	MS
22 Jul 2015Drug	CLASS III	HydrOXYzine Hydrochloride Tablets, USP 25 mg recalled	Qualitest Pharmaceuticals	Other	Nationwide