US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class III · Low risk Terminated

Azelastine Hydrochloride Nasal Solution

Reason Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..

Roxane Laboratories, Inc. NDC 0054-0293-99 D-0448-2017
Class II · Moderate risk Terminated

Torsemide Tablets

Reason CGMP Deviations

Apotex Corp. NDC 60505-0232-01 D-0245-2017
Class II · Moderate risk Terminated

Torsemide Tablets

Reason CGMP Deviations

Apotex Corp. NDC 60505-0234-01 D-0244-2017
Class I · High risk Terminated

Nano PNC Water

Reason Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.

Pacific Medical Solutions D-0505-2017
Class III · Low risk Terminated

Donepezil Hydrochloride Tablets

Reason Subpotent Drug: out of specification results for assay test.

Sandoz Inc NDC 0781-5275-31 D-0435-2017
Class III · Low risk Terminated

VirtPrex Prenatal/Postnatal Tablets

Reason cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

Virtus Pharmaceuticals Opco II L NDC 76439-348-30 D-0241-2017
Class III · Low risk Terminated

Virt-Select Prenatal/Postnatal Softgels

Reason cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

Virtus Pharmaceuticals Opco II L NDC 76439-249-30 D-0240-2017
Class III · Low risk Terminated

Extra-Virt Plus DHA Prenatal/Postnatal Softgel

Reason cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

Virtus Pharmaceuticals Opco II L NDC 76439-251-30 D-0239-2017
Class III · Low risk Terminated

Virt-Advance Prenatal/Postnatal Softgels

Reason cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

Virtus Pharmaceuticals Opco II L NDC 76439-357-90 D-0238-2017
Class I · High risk Terminated

SLIMFIT X capsules

Reason Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.

Jersey Shore Supplements, LLC D-0473-2017
Class III · Low risk Terminated

Novacort Gel Sample Packets

Reason Subpotent Drug: Out of specification result for pramoxine hydrochloride

Novum Pharma, LLC NDC 69646-704-38 D-0433-2017
Class II · Moderate risk Terminated

10% Premasol sulfite-free

Reason Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.

Baxter Healthcare Corporation NDC 0338-1130-06 D-0425-2017
Class II · Moderate risk Terminated

Fluconazole Injection

Reason Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.

Baxter Healthcare Corporation NDC 0338-6046-48 D-0206-2017
Class III · Low risk Terminated

Endure 400 Scrub-Stat

Reason Subpotent Drug

Ecolab, Inc. NDC 47593-265-36 D-0454-2017
Class III · Low risk Terminated

Pentasa

Reason Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules

Shire PLC NDC 54092-189-81 D-0432-2017
Class I · High risk Terminated

MegaJex Herbal Supplement

Reason Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED)

MS Bionic D-0472-2017
Class I · High risk Terminated

Domperidone capsules 10 mg

Reason Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.

Jeffreys Drug Store D-0494-2017
Class III · Low risk Terminated

Protonix I.V.

Reason Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.

Pfizer Inc. NDC 0008-0923-51 D-0516-2017