CLASS III Drug recall · Reported 18 Dec 2013 · FDA Enforcement Report
Ethambutol Hydrochloride Tablets USP, 400 mg recalled
Lupin Pharmaceuticals is recalling Ethambutol Hydrochloride Tablets USP, 400 mg, distributed nationwide in the US. The recall was initiated on 22 Feb 2013 and the FDA has classified it as Class III.
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-346-2014
- FDA event ID
- 66065
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Feb 2013
- FDA classified
- 12 Dec 2013
- Reported
- 18 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 22 Feb 2013 | Recall initiated by company | |
| 12 Dec 2013 | Classified by FDA | +293 days |
| 18 Dec 2013 | 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
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
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
Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-281-01, UPC 3 68180 28101 6.
Where it was distributed
Nationwide
Questions about this recall
Is Ethambutol Hydrochloride Tablets USP, 400 mg recalled?
Yes. Lupin Pharmaceuticals recalled Ethambutol Hydrochloride Tablets USP, 400 mg on 22 Feb 2013. The recall is Class III and its status is Terminated. Recall number D-346-2014.
Why was it recalled?
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Which lots are affected?
Lot #: 3122856, Exp 05/14
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 21 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 Ethambutol recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ethambutol Hydrochloride Tablets recalled by West-ward Pharmaceutical | West-ward Pharmaceutical | Potency & Assay | Nationwide |