Duloxetine Delayed-Release Capsules USP recall
FDA recall D-0388-2025 · initiated Apr 14, 2025
Breckenridge Pharmaceutical, Inc recalled Duloxetine Delayed-Release Capsules USP in Apr 2025 — an FDA Class II recall (D-0388-2025) because CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 343,344 bottles
Details
- Product
- Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922
- Recalling company
- Breckenridge
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Apr 14, 2025
- FDA report date
- Apr 30, 2025
Frequently asked
- Was Duloxetine Delayed-Release Capsules USP recalled?
- Breckenridge Pharmaceutical, Inc recalled Duloxetine Delayed-Release Capsules USP in Apr 2025 — an FDA Class II recall (D-0388-2025) because CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Duloxetine Delayed-Release Capsules USP recalled?
- Per the FDA enforcement record, the reason for recall D-0388-2025 was: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- Is a recalled Duloxetine Delayed-Release Capsules USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Duloxetine Delayed-Release Capsules USP are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot # 230201C, exp. date 01/2026 230471C, exp. date 01/2026 230288C, exp. date 01/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0388-2025.