Notice names this product. Breckenridge Pharmaceutical’s Duloxetine Delayed-Release Capsules USP is named in FDA Class II recall D-0522-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Identifying details: Lot: 241069C, Exp 05/31/2027. Units affected: 165,761 90-count bottles. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Company / brand: Breckenridge Pharmaceutical
Affected product: Duloxetine Delayed-Release Capsules USP
Official ID D-0522-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.