Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0830-2020·Announced 2020-02-12

Teva Recalls Desmopressin Acetate Tablets Due to Missing Desiccant

Teva Pharmaceuticals USA is recalling Desmopressin Acetate Tablets because bottles may be missing desiccant, a GMP deviation.

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 and involves a GMP deviation (missing desiccant) which is a low-risk contamination or stability issue without reported illness, fitting the Moderate criteria.

Plain-English summary

Teva Pharmaceuticals USA is recalling Desmopressin Acetate Tablets, 0.1 mg, 100-count bottles. The recall involves 22,868 bottles distributed nationwide within the United States. The specific lots affected are 1281203M (exp. 03/2020) and 1290113M (exp. 04/2020).

The reason for the recall is a Good Manufacturing Practice (GMP) deviation where the product bottle may be absent of desiccant. Desiccants are used to absorb moisture and maintain product stability.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be returned to the pharmacy or distributor for replacement or refund.

The recalled product

Product: Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2464-01
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Prescription Medication
Hazard: gmp-deviation
missing-desiccant
Affected units: 22,868

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 (3)

Lot #: 1281203M
exp. date 03/2020 and 1290113M
exp. date 04/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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.

See all 2 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · gmp deviation