CLASS II Drug recall · Reported 6 Jul 2022 · FDA Enforcement Report
Desmopressin Acetate Tablets, 0.2 mg recalled
Glenmark Pharmaceuticals Inc., USA is recalling Desmopressin Acetate Tablets, 0.2 mg, distributed in Texas. The recall was initiated on 29 Jun 2022 and the FDA has classified it as Class II.
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-1171-2022
- FDA event ID
- 90431
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jun 2022
- FDA classified
- 30 Jun 2022
- Reported
- 6 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 29 Jun 2022 | Recall initiated by company | |
| 30 Jun 2022 | Classified by FDA | +1 day |
| 6 Jul 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01
Where it was distributed
One sole distributor in TX
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot #: 20020121, Exp 01/2024
Where was it sold?
One sole distributor in TX
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
More recalls from Glenmark Pharmaceuticals Inc., USA
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|---|---|---|---|---|---|
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| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
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 Injection USP, 4 mcg/mL Preserved Vial recalled | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS I | Desmopressin Acetate Nasal Spray 10 mcg/ glass vial with spray cap recalled | Ferring Pharmaceuticals | Potency & Assay | Nationwide |