What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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.) and recall number D-0522-2026, then follow Breckenridge Pharmaceutical, Inc.'s recall instructions.

Has Breckenridge Pharmaceutical, Inc. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 3 total FDA actions tied to Breckenridge Pharmaceutical, Inc., including 3 recalls and 0 warning letters.

FDA Class II Recall: DULOXETINE by Breckenridge Pharmaceutical, Inc.

Key facts

Recalling firm	Breckenridge Pharmaceutical, Inc.
Manufacturer	Breckenridge Pharmaceutical, Inc.
Brand name	DULOXETINE
Product description	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.
Classification	Class II
Recall number	D-0522-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Key takeaway: Breckenridge Pharmaceutical, Inc. recalled 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. on 2026-05-13. FDA classified this action as a Class II recall (recall number D-0522-2026). Reason for recall: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit. Recall status: Ongoing. This is a drug-category FDA recall record.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- 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. -- and the recall number D-0522-2026. If it matches, stop using or distributing it and contact Breckenridge Pharmaceutical, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Breckenridge Pharmaceutical, Inc. and the affected product is described in FDA's record as: 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.. FDA's stated reason for the recall is: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit. The recall is tracked under FDA recall number D-0522-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

Breckenridge Pharmaceutical, Inc.’s FDA history

Argus HQ has recorded 3 total FDA actions tied to Breckenridge Pharmaceutical, Inc.: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What was recalled and why?: Breckenridge Pharmaceutical, Inc. recalled 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.. FDA's record states the reason for recall as: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit. The recall is logged under FDA recall number D-0522-2026 with a Class II classification.
How serious is this recall?: FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
What should someone who has this product do?: Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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.) and recall number D-0522-2026, then follow Breckenridge Pharmaceutical, Inc.'s recall instructions.
Has Breckenridge Pharmaceutical, Inc. had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 3 total FDA actions tied to Breckenridge Pharmaceutical, Inc., including 3 recalls and 0 warning letters.

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Full FDA history for Breckenridge Pharmaceutical, Inc.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Class II Recall: DULOXETINE by Breckenridge Pharmaceutical, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-breckenridge-pharmaceutical-inc-d-0522-2026

MLA

"FDA Class II Recall: DULOXETINE by Breckenridge Pharmaceutical, Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-breckenridge-pharmaceutical-inc-d-0522-2026.

Chicago

Argus HQ Research. "FDA Class II Recall: DULOXETINE by Breckenridge Pharmaceutical, Inc.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-breckenridge-pharmaceutical-inc-d-0522-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_breckenridge_pharmaceutical_inc_d_0522_2026_2026,
  title = {FDA Class II Recall: DULOXETINE by Breckenridge Pharmaceutical, Inc.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-breckenridge-pharmaceutical-inc-d-0522-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗