CLASS III Drug recall · Reported 12 Aug 2015 · FDA Enforcement Report

Desmopressin Acetate Tablets, 1mg recalled by Actavis Laboratories, FL

Actavis Laboratories, FL is recalling Desmopressin Acetate Tablets, 1mg, distributed nationwide in the US. The recall was initiated on 23 Jun 2015 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot # 982021M, Expiry: DEC. 2016
Quantity recalled11,445 Bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-1285-2015
FDA event ID
71755
Recalling firm
Actavis Laboratories, FL, Davie, FL
Classification
Class III
Status
Terminated
Recall initiated
23 Jun 2015
FDA classified
4 Aug 2015
Reported
12 Aug 2015
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Other Reasons

Timeline

23 Jun 2015Recall initiated by company
4 Aug 2015Classified by FDA+42 days
12 Aug 2015Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.

Product as listed by the FDA

Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by Actavis Pharma, Inc. Parsippany, NJ 07054 USA. NDC: 0591-2464-01.

Where it was distributed

U.S. Nationwide including Puerto Rico.

Nationwide Puerto Rico

Questions about this recall

Is Desmopressin Acetate Tablets, 1mg recalled?

Yes. Actavis Laboratories, FL recalled Desmopressin Acetate Tablets, 1mg on 23 Jun 2015. The recall is Class III and its status is Terminated. Recall number D-1285-2015.

Why was it recalled?

Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.

Which lots are affected?

Lot # 982021M, Expiry: DEC. 2016

Where was it sold?

U.S. Nationwide including Puerto Rico.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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