Class III · Low risk
Duloxetine Delayed-Release Capsules USP
Failed Dissolution Specification
Is Duloxetine recalled?
Yes — there is an active recall. 44 ongoing FDA recalls mention Duloxetine (63 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Duloxetine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Duloxetine recalls on record
none so far in 2026; 63 on record, newest first
Class II · Moderate risk
Duloxetine Delayed-release Capsules USP
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Class II · Moderate risk
Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles
Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.
Class III · Low risk
DULOXETINE Delayed-Release Capsules
Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018
Class III · Low risk
Duloxetine Delayed-Release Capsules
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk
Duloxetine Delayed-Release Capsules
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk
Duloxetine Delayed-Release Capsules
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk
Duloxetine Delayed-release Capsules
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Class II · Moderate risk
Duloxetine HCl active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.
Class II · Moderate risk
DULoxetine HCl DR
Labeling: Label Mixup: DULoxetine HCl DR, Capsule, 20 mg, may be potentially mis-labeled with one of the following drugs: ENTECAVIR, Tablet, 0.5 mg, NDC 00003161112, Pedigree: AD30140_28, EXP: 5/7/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD54587_1, EXP: 5/21/2014; FLUoxetine HCl, Capsule, 10 mg , NDC 16714035103, Pedigree: AD70585_13, EXP: 5/29/2014; CHOLECALCIFEROL
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