CLASS II Drug recall · Reported 11 Mar 2015 · FDA Enforcement Report

Vancomycin Hydrochloride Capsules, USP, 125 mg, count recalled

Actavis is recalling Vancomycin Hydrochloride Capsules, USP, 125 mg, count, distributed nationwide in the US. The recall was initiated on 12 Feb 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 310935 Exp 3/31/2015; Lot #: 3109552 Exp 3/31/2015; Lot #: 3110204, Exp 3/31/2015; Lot #: 3112972, Exp 7/31/2015; Lot #: 3114073, Exp 8/31/2015; Lot #: 3115756, Exp 10/31/2015, Lot #: 3115888, Exp 10/31/2015; Lot #: 3118059, Exp 11/30/2015.

Quantity recalled51,472 cartons

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-0396-2015
FDA event ID: 70555
Recalling firm: Actavis, Parsippany, NJ
Classification: Class II
Status: Terminated
Recall initiated: 12 Feb 2015
FDA classified: 3 Mar 2015
Reported: 11 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Antibiotics

Timeline

12 Feb 2015	Recall initiated by company
3 Mar 2015	Classified by FDA	+19 days
11 Mar 2015	Published in enforcement report	+8 days

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

Reason for recall

Subpotent Drug

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

Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3560-15

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Subpotent Drug

Which lots are affected?

Lot #: 310935 Exp 3/31/2015; Lot #: 3109552 Exp 3/31/2015; Lot #: 3110204, Exp 3/31/2015; Lot #: 3112972, Exp 7/31/2015; Lot #: 3114073, Exp 8/31/2015; Lot #: 3115756, Exp 10/31/2015, Lot #: 3115888, Exp 10/31/2015; Lot #: 3118059, Exp 11/30/2015.

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 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

1 other product · FDA event 70555

This product is part of a recall event; the main page for the event is Vancomycin Hydrochloride Capsules, USP, 250 mg, count recalled.

Reported	Class	Recall	Company	Reason	Where
11 Mar 2015	CLASS II	Vancomycin Hydrochloride Capsules, USP, 250 mg, count recalled	Actavis	Potency & Assay	Nationwide

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Other Vancomycin recalls

All 65

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Vancomycin Injection, USP in 5% Dextrose per (5 mg/mL) recalledVancomycin Hydrochloride	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
9 Sep 2026Drug	CLASS II	Vancomycin Injection, USP, in 0.9% Sodium Chloride recalledVancomycin Hydrochloride	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
24 Apr 2024Drug	CLASS I	Vancomycin Hydrochloride for Oral Solution, USP, 250 mg recalledVancomycin Hydrochloride	Amneal Pharmaceuticals of New York	Potency & Assay	Nationwide
25 Oct 2023Drug	CLASS II	Vancomycin 1 MG/ Solution for Intraocular Injection Single Dose Vial recalled	Pine Pharmaceuticals	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	vancomycin 750 mg/ added to 0.9% Sodium Chloride, (3 mg/mL), IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide