Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0299-2015·Announced 2014-12-24

Zydus Recalls Benzonatate Capsules Due to Wet or Leaking Capsules

Zydus Pharmaceuticals is recalling 58,920 bottles of Benzonatate Capsules, 200 mg, because some capsules are wet or leaking.

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. The hazard is a physical defect (wet/leaking capsules) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving minor defects or low-risk issues.

Plain-English summary

Zydus Pharmaceuticals USA Inc is recalling 58,920 bottles of Benzonatate Capsules, USP, 200 mg, 100-count bottles. The product is prescription-only and was distributed nationwide and in Puerto Rico.

The recall was initiated because some capsules failed specifications by being wet and/or leaking. The affected lots are MP2137, MP2138, and MP2139 (Exp 01/16); MP3614 (Exp 03/16); and MP5611 and MP5613 (Exp 05/16). The product was manufactured by Cadila Healthcare Ltd in Ahmedabad, India, and distributed by Zydus Pharmaceuticals USA Inc in Pennington, NJ.

Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement. The FDA has classified this as a Class II recall.

The recalled product

Product: Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; NDC 68382-248-01, UPC 3 68382 24801 5.
Manufacturer: Zydus Pharmaceuticals USA Inc
Category: Drug — Prescription Medication
Hazard: physical-defect
leaking-capsule
Affected units: 58,920

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 (9)

Lot #: MP2137
MP2138
MP2139
Exp 01/16
MP3614
Exp 03/16
MP5611
MP5613
Exp 05/16

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Zydus Pharmaceuticals USA Inc

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