CLASS II Drug recall · Reported 5 Nov 2014 · FDA Enforcement Report
Vancomycin Hydrochloride Capsule, USP, 125 mg recalled by Actavis
Actavis is recalling Vancomycin Hydrochloride Capsule, USP, 125 mg, distributed nationwide in the US. The recall was initiated on 25 Aug 2014 and the FDA has classified it as Class II.
Check your package
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-0232-2015
- FDA event ID
- 69553
- Recalling firm
- Actavis, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Aug 2014
- FDA classified
- 30 Oct 2014
- Reported
- 5 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 25 Aug 2014 | Recall initiated by company | |
| 30 Oct 2014 | Classified by FDA | +66 days |
| 5 Nov 2014 | 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
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 Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3560-15 UPC Code 3-0591356015-4
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
3103681, exp Aug 2014, 3104886, exp Oct 2014, 3105836, exp Dec 2014, and 3106650, exp Dec 2014
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 69553| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Vancomycin Hydrochloride Capsule, USP, 250 mg recalled by Actavis | Actavis | Potency & Assay | Nationwide |
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|---|---|---|---|---|---|
| Drug | CLASS III | Levofloxacin Ophthalmic Solution, 0.5%, Sterile recalled by Actavis | Actavis | Potency & Assay | Nationwide |
| Drug | CLASS II | Glipizide extended-release tablets, 2.5mg recalled by Actavis | Actavis | Potency & Assay | Nationwide |
| Drug | CLASS III | Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / Vials recalled | Actavis | Potency & Assay | Nationwide |
| Drug | CLASS III | Hydrocortisone and acetic acid otic solution recalled by Actavis | Actavis | Potency & Assay | Nationwide |
| Drug | CLASS III | Acetasol HC (hydrocortisone and acetic acid otic solution USP) recalled | Actavis | Potency & Assay | Nationwide |
Other Vancomycin recalls
All 65| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vancomycin Injection, USP in 5% Dextrose per (5 mg/mL) recalledVancomycin Hydrochloride | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Vancomycin Injection, USP, in 0.9% Sodium Chloride recalledVancomycin Hydrochloride | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg recalledVancomycin Hydrochloride | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Vancomycin 1 MG/ Solution for Intraocular Injection Single Dose Vial recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | vancomycin 750 mg/ added to 0.9% Sodium Chloride, (3 mg/mL), IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |