FDA Drug Recalls

1,709 recalls · Class III, newest first

Class III · Low risk Terminated Aug 23, 2022

ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC…

Reason Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules

Leading Pharma, LLC NDC 69315-167-01 D-1546-2022

Class III · Low risk Ongoing Aug 8, 2022

Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc…

Reason Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.

Akorn, Inc NDC 17478-189-24 D-1471-2022

Class III · Low risk Terminated Aug 4, 2022

Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc…

Reason Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.

LNK International, Inc. D-1472-2022

Class III · Low risk Terminated Aug 4, 2022

Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC…

Reason Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

Akron Pharma, Inc. NDC 71399-8022-01 D-1353-2022

Class III · Low risk Terminated Aug 4, 2022

Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02)…

Reason Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

Akron Pharma, Inc. NDC 71399-8024-01 D-1352-2022

Class III · Low risk Terminated Aug 2, 2022

Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only…

Reason Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit

Heron Therapeutics, INC. NDC 47426-301-02 D-1335-2022

Class III · Low risk Terminated Jul 27, 2022

Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals…

Reason Subpotent Drug

Amerisource Health Services LLC NDC 68001-0313-56 D-1349-2022

Class III · Low risk Terminated Jul 22, 2022

Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint…

Reason Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.

Teva Pharmaceuticals USA Inc NDC 68001-313-56 D-1334-2022

Class III · Low risk Terminated Jul 20, 2022

Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10…

Reason Labeling: Label Error on Declared Strength

AVKARE Inc. NDC 42291-367-10 D-1329-2022

Class III · Low risk Ongoing Jul 11, 2022

Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g…

Reason Defective Container: Tube split from side seam

Glenmark Pharmaceuticals Inc., USA NDC 68462-534-35 D-1304-2022

Class III · Low risk Completed Jul 8, 2022

Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.243% sodium fluoride, Net Wt. 5.6 oz (158 g) a)…

Reason Labeling: Missing label: the product tube was missing a label and contained a different formulation.

The Procter & Gamble Company D-1290-2022

Class III · Low risk Terminated Jun 29, 2022

Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g)…

Reason Failed Dissolution Specifications

Eco Lips, Inc D-1299-2022

Class III · Low risk Terminated Jun 29, 2022

Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube…

Reason Failed Dissolution Specifications

Eco Lips, Inc D-1298-2022

Class III · Low risk Ongoing Jun 29, 2022

Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx Only, Manufactured for: Glenmark…

Reason Failed Tablet/Capsule Specification : Capsule breakage

Glenmark Pharmaceuticals Inc., USA NDC 68462-405-60 D-1282-2022

Class III · Low risk Terminated Jun 21, 2022

Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories…

Reason Superpotent Drug: Out of specification for assay at the 12-month timepoint.

Sun Pharmaceutical Industries INC NDC 63304-735-90 D-0005-2023

Class III · Low risk Terminated Jun 21, 2022

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories…

Reason Superpotent Drug: Out of specification for assay at the 12-month timepoint.

Sun Pharmaceutical Industries INC NDC 63304-734-90 D-0004-2023

Class III · Low risk Terminated Jun 16, 2022

Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02)…

Reason Defective Container

Glenmark Pharmaceuticals Inc., USA NDC 68462-385-37 D-1173-2022

Class III · Low risk Terminated May 18, 2022

Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed…

Reason Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing

Teva Pharmaceuticals USA Inc NDC 0703-1501-02 D-0988-2022

Class III · Low risk Terminated May 13, 2022

Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured for: ViiV Healthcare RTP, NC 27709, NDC 49702-228-13.

Reason Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date…

GlaxoSmithKline LLC NDC 49702-228-13 D-0896-2022

Class III · Low risk Terminated May 10, 2022

Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC…

Reason Failed Impurities/Degradation Specifications.

Novartis Pharmaceuticals Corporation NDC 54092-606-07 D-0985-2022

Class III · Low risk Terminated May 10, 2022

Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC…

Reason Failed Impurities/Degradation Specifications.

Novartis Pharmaceuticals Corporation NDC 0078-0911-95 D-0984-2022

Class III · Low risk Terminated May 10, 2022

Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2…

Reason Failed Impurities/Degradation Specifications.

Novartis Pharmaceuticals Corporation NDC 54092-606-01 D-0983-2022

Class III · Low risk Terminated May 10, 2022

Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL…

Reason Failed Impurities/Degradation Specifications.

Novartis Pharmaceuticals Corporation NDC 0078-0911-12 D-0982-2022

Class III · Low risk Terminated May 3, 2022

Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9…

Reason Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.

Apotex Corp. NDC 60505-6197-2 D-0881-2022

Class III · Low risk Terminated May 3, 2022

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards…

Reason Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results…

American Health Packaging NDC 68084-446-11 D-0880-2022