Food, drugs, devices › Actavis Laboratories, FL, Inc.
Drug recall: Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by: Actavis Laboratories FL, Inc., Fort La
Actavis Laboratories, FL, Inc. (Davie, FL) initiated this drug recall on 23 Jun 2015; FDA lists 1 product record under event 71755, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 31% of the 292 drug enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 30 Dec 2016. Initiation: voluntary: firm initiated. Actavis Laboratories, FL, Inc. has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Actavis Laboratories, FL, Inc., Davie, FL.
Reason for recall
"Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side."
Distribution
"U.S. Nationwide including Puerto Rico."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1285-2015 | 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. | 11,445 Bottles | Class III | Terminated | 12 Aug 2015 |
Context
Other enforcement events for Actavis Laboratories, FL, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 30 Aug 2016 | Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG30 | Drug | Class III | 1 |
| 25 Sep 2015 | Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratori | Drug | Class II | 1 |
| 26 Mar 2015 | Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufact | Drug | Class III | 1 |
| 26 Sep 2014 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by: Wats | Drug | Class II | 1 |
| 24 Apr 2014 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Wats | Drug | Class II | 2 |
All 6 events for Actavis Laboratories, FL, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "U.S. Nationwide including Puerto Rico."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Dec 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.