FDA recalls prescription desmopressin acetate tablets for subpotency
Heritage Pharmaceuticals' desmopressin acetate tablets (0.2mg) have been recalled nationwide due to subpotency. The voluntary recall affects 13,805 bottles; no illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II prescription drug with subpotency (below-labeled potency) and no reported illnesses or injuries. This represents a risk-of-harm scenario—therapeutic failure due to insufficient active ingredient—without confirmed patient harm, meeting the rubric criterion for High severity.
Plain-English summary
Heritage Pharmaceuticals Inc is recalling desmopressin acetate 0.2mg tablets nationwide due to subpotency. The affected product (lot #220440A, expiring May 2024) contains less active ingredient than the label indicates.
The recall involves 13,805 bottles, each containing 100 tablets. The product is an oral prescription medication distributed through Avet Pharmaceuticals Inc in East Brunswick, New Jersey, under NDC 23155-490-01.
No illnesses or injuries have been reported in connection with this recall. Patients currently taking this medication should consult their healthcare provider to confirm they have received the correct dosage. The manufacturer voluntarily initiated the recall on November 23, 2022, and the recall was terminated on December 13, 2023.
The recalled product
- Product
- DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE)
- Brand
- DESMOPRESSIN ACETATE
- Manufacturer
- Heritage Pharmaceuticals Inc
- Category
- Drug
- Hazard
- subpotency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 220440A
- Exp. Date 05/2024
Distribution
Distributed nationwide across the United States.
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