Teva Recalls Ethambutol Hydrochloride Tablets Due to Incorrect Excipient
Teva Pharmaceuticals is recalling specific lots of Ethambutol Hydrochloride Tablets because they were manufactured with an unapproved gelatin excipient.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which is generally remote or unlikely to cause temporary or medically reversible health consequences. The hazard is a CGMP deviation involving an incorrect excipient, which fits the criteria for a moderate severity recall without reported injuries.
Plain-English summary
Teva Pharmaceuticals USA is recalling specific lots of Ethambutol Hydrochloride Tablets, USP, 400 mg. The affected product is distributed in 100-count bottles and is available by prescription only. The recall covers approximately 10,405 tablets from four specific lots with expiration dates of 01/16.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The tablets were manufactured using an unapproved material, specifically the incorrect gelatin excipient, rather than the one specified in the product formulation. This deviation from the approved formulation constitutes a quality issue.
The affected lots were distributed nationwide. Patients and healthcare providers should check their medication bottles for the specific lot numbers and expiration dates listed in the recall notice. If the medication matches the recalled lots, it should be returned to the pharmacy or contact Teva Pharmaceuticals for further instructions.
The recalled product
- Product
- Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Antibiotic
- Affected units
- 10,405
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot # 34013698A
- Exp. 01/16. Lot # 34013699A
- Exp. 01/16. Lot # 34013700A
- Exp. 01/16. Lot # 34013756A
- Exp. 01/16.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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