CLASS II Drug recall · Reported 25 Jun 2014 · FDA Enforcement Report
Vancomycin Hydrochloride Capsules recalled by Actavis
Actavis is recalling Vancomycin Hydrochloride Capsules, USP, 250 mg. on Capsule Blister Cards, distributed nationwide in the US. The recall was initiated on 16 May 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-1386-2014
- FDA event ID
- 68453
- Recalling firm
- Actavis, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 May 2014
- FDA classified
- 17 Jun 2014
- Reported
- 25 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 16 May 2014 | Recall initiated by company | |
| 17 Jun 2014 | Classified by FDA | +32 days |
| 25 Jun 2014 | 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, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx Only. Mfd. for: Watson Pharma Inc., Parsippany, NJ 07054 USA. Mfd. by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237 USA. NDC 0591-3561-15.
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug.
Which lots are affected?
Lot #: 3100135, Expiry: 05/2014
Where was it sold?
U.S. 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.
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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 |