The Recall Desk
ModerateFDA (Drugs)·D-0831-2020·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.

What this means for you

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 due to a GMP deviation (missing desiccant) which poses a theoretical risk to product stability, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Teva Pharmaceuticals USA is recalling Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles. The recall was initiated due to a Good Manufacturing Practice (GMP) deviation where the product bottles may be absent of desiccant.

The affected product is identified by NDC 0591-2465-01. Specific lots involved include 1269726M (exp. 01/2020), 1283269M and 1283270M (exp. 03/2020), and 1292992M and 1292993A (exp. 04/2020). A total of 69,012 bottles were distributed nationwide within the United States.

The FDA has classified this recall as Class II. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or distributor for credit or replacement.

The recalled product

Product
Desmopressin Acetate Tablets, 0.2 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 0591-2465-01
Affected units
69,012

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 #: 1269726M
  • exp. date 01/2020
  • 1283269M
  • 1283270M
  • exp. date 03/2020
  • 1292992M
  • 1292993A
  • 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 →