Class III · Low risk Terminated
Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc…
Reason Failed Dissolution Specification
Is Duloxetine recalled?
63 FDA recalls mention Duloxetine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Duloxetine.
Class II · Moderate risk Terminated
Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx…
Reason Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Class II · Moderate risk Terminated
Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited…
Reason Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count…
Class III · Low risk Terminated
DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only, Manufactured by: Laboratorios del Dr. Esteve, SA…
Reason 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 Terminated
Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L…
Reason Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk Terminated
Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L…
Reason Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk Terminated
Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L…
Reason Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk Terminated
Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A…
Reason Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Class II · Moderate risk Terminated
Duloxetine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical…
Reason Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg &…
Class II · Moderate risk Terminated
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical…
Reason Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg &…
Class II · Moderate risk Terminated
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx Only, 60 capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical…
Reason Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg &…
Class II · Moderate risk Terminated
DULoxetine HCl DR, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323560.
Reason 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…
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