Agency classClass IIIOur severity:Low FDA (Drugs)·D-0289-2015·Announced 2014-12-10

Zydus Recalls Benzonatate Capsules Due to Foreign Capsule Contamination

Zydus Pharmaceuticals USA is recalling Benzonatate 200 mg capsules because they may contain foreign 100 mg capsules.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor or theoretical risks.

Plain-English summary

Zydus Pharmaceuticals USA, Inc. is recalling Benzonatate Capsules, USP, 200 mg, 100 Capsule Bottles. The recall is due to the presence of foreign capsules, specifically Benzonatate 100 mg capsules, co-mingled with the 200 mg capsules.

The affected product is distributed by Zydus Pharmaceuticals USA, Inc. and manufactured by Cadila Healthcare Ltd, Ahmedabad, India. The recall covers 63,648 bottles distributed nationwide in the United States, including Puerto Rico. The affected lots are MM8555, MM6604, MM8551, MM8552, MM8553, and MM8554, all with an expiration date of 09/14.

Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the description. The FDA has classified this as a Class III recall, indicating that the product is not likely to cause adverse health consequences.

The recalled product

Product: BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only. Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc. NDC: 68382-248-01
Manufacturer: Zydus Pharmaceuticals USA Inc
Category: Drug — Prescription Medication
Hazard: foreign-object
mis-labeling
Affected units: 63,648

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 (8)

Lot #: MM8555
Expiry: 09/14
Lot #: MM6604
Lot #: MM8551
Lot #: MM8552
Lot #: MM8553
Lot #: MM8554
Expiry: 09/14.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Zydus Pharmaceuticals USA Inc

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