CLASS III Drug recall · Reported 12 Aug 2015 · FDA Enforcement Report
Desmopressin Acetate Tablets, 0.1mg recalled by Actavis Laboratories, FL
Actavis Laboratories FL is recalling Desmopressin Acetate Tablets, 0.1mg, 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
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 2015 | Recall initiated by company | |
| 4 Aug 2015 | Classified by FDA | +42 days |
| 12 Aug 2015 | Published 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.
Questions about this recall
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 26 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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| Drug | CLASS III | Ramipril Capsules, USP, 1.25 mg recalled by Actavis Laboratories, FL | Actavis Laboratories FL | Other | Nationwide |
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Other Desmopressin recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled | Apotex | Other | Nationwide |
| Drug | CLASS II | Desmopressin Acetate Tablet, 0.2 mg recalled by RemedyRepack | RemedyRepack | Potency & Assay | MI |
| Drug | CLASS II | Desmopressin Acetate Tablets 0.2mg recalled by Heritage PharmaceuticalsDesmopressin Acetate | Heritage Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Desmopressin Acetate Tablets, 0.2 mg recalled | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | TX |
| Drug | CLASS II | Desmopressin Acetate Injection USP, 4 mcg/mL Preserved Vial recalled | Teva Pharmaceuticals USA | Sterility | Nationwide |