CLASS II Drug recall · Reported 7 Dec 2022 · FDA Enforcement Report
Desmopressin Acetate Tablets 0.2mg recalled by Heritage Pharmaceuticals
Heritage Pharmaceuticals is recalling Desmopressin Acetate Tablets 0.2mg, distributed nationwide in the US. The recall was initiated on 23 Nov 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-0072-2023
- FDA event ID
- 91171
- Recalling firm
- Heritage Pharmaceuticals, East Brunswick, NJ
- Brand
- Desmopressin Acetate
- Manufacturer
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Nov 2022
- FDA classified
- 29 Nov 2022
- Reported
- 7 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 23 Nov 2022 | Recall initiated by company | |
| 29 Nov 2022 | Classified by FDA | +6 days |
| 7 Dec 2022 | 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
Subpotent Drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816, NDC 23155-490-01
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot #: 220440A, Exp. Date 05/2024
Where was it sold?
Nationwide within the United States
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 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.
More recalls from Heritage Pharmaceuticals
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin Palmitate Hydrochloride For Oral Solution, USP, 75 mg recalledClindamycin Palmitate Hydrochloride | Heritage Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 75 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 100 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 50 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 10 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
Other Desmopressin recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Desmopressin Acetate Tablet, 0.2 mg recalled by RemedyRepack | RemedyRepack | Potency & Assay | MI |
| Drug | CLASS II | Desmopressin Acetate Tablets, 0.2 mg recalled | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | TX |
| Drug | CLASS II | Desmopressin Acetate Injection USP, 4 mcg/mL Preserved Vial recalled | Teva Pharmaceuticals U | Sterility | Nationwide |
| Drug | CLASS II | Desmopressin Acetate Tablets, 0.2 mg ( unit dose blister cards) recalled | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS II | Desmopressin Acetate Tablets, 0.1 mg ( unit dose blister cards) recalled | American Health Packaging | Packaging Defects | Nationwide |