FDA Drug Recalls

1,709 recalls · Class III, newest first

Class III · Low risk Terminated Jul 11, 2019

Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin…

Reason Labeling: Missing label; Product complaints reported missing bottle label.

Lupin Pharmaceuticals Inc. NDC 68180-435-01 D-1490-2019

Class III · Low risk Terminated Jun 25, 2019

Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count UPC 8-8397-38781-6 and b) 500 count UPC…

Reason Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the…

AAA Pharmaceutical, Inc. D-1585-2019

Class III · Low risk Terminated Jun 17, 2019

Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant…

Reason Failed Stability Specifications: Out of specification for viscosity.

Bausch & Lomb NDC 24208-503-07 D-1396-2019

Class III · Low risk Terminated Jun 12, 2019

Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total…

Reason Defective Container; actuator may improperly function and affect dose delivery.

InvaGen Pharmaceuticals, Inc. NDC 69097-363-44 D-1454-2019

Class III · Low risk Terminated Jun 7, 2019

Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, Rx Only…

Reason Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.

Akorn Inc NDC 61748-304-13 D-1392-2019

Class III · Low risk Terminated May 22, 2019

Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20

Reason Failed Impurities/Degradation Specifications.

Fresenius Kabi USA, LLC NDC 63323-374-20 D-1386-2019

Class III · Low risk Terminated May 20, 2019

Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51)…

Reason Failed Impurities/Degradation Specifications

Teligent Pharma, Inc. NDC 52565-019-15 D-1391-2019

Class III · Low risk Terminated May 10, 2019

QUIK-CARE Aerosol Foam Hand Sanitizer (62.5% Ethyl Alcohol), packaged in 7 oz cans, Ecolab, 370 Wabasha Street N, St. Paul, MN…

Reason Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.

Ecolab Inc NDC 47593-490-82 D-1393-2019

Class III · Low risk Terminated Apr 29, 2019

Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05; b) 6 tablets 1 card…

Reason Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains…

Pfizer Inc. NDC 0049-2340-05 D-1278-2019

Class III · Low risk Terminated Apr 25, 2019

Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%; full case of 12-2 oz. cans only…

Reason Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net…

Advantice Health D-1280-2019

Class III · Low risk Terminated Apr 25, 2019

Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%, Net WT 2.75 oz (78g); Distributed by…

Reason Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.

Advantice Health D-1279-2019

Class III · Low risk Terminated Apr 23, 2019

Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn…

Reason Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.

Akorn Inc NDC 17478-030-25 D-1241-2019

Class III · Low risk Terminated Apr 22, 2019

Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by…

Reason Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another…

Zydus Pharmaceuticals USA Inc NDC 68382-092-05 D-1242-2019

Class III · Low risk Terminated Apr 10, 2019

Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ…

Reason Failed Impurities/Degradation Specifications

Lupin Somerset NDC 43386-544-01 D-1247-2019

Class III · Low risk Terminated Apr 10, 2019

Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc…

Reason Failed Impurities/Degradation Specifications

Lupin Somerset NDC 43386-543-01 D-1246-2019

Class III · Low risk Terminated Apr 10, 2019

Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset…

Reason Failed Impurities/Degradation Specifications

Lupin Somerset NDC 43386-542-01 D-1245-2019

Class III · Low risk Terminated Apr 10, 2019

Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset…

Reason Failed Impurities/Degradation Specifications

Lupin Somerset NDC 43386-541-01 D-1244-2019

Class III · Low risk Terminated Apr 10, 2019

Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset…

Reason Failed Impurities/Degradation Specifications

Lupin Somerset NDC 43386-540-01 D-1243-2019

Class III · Low risk Terminated Apr 3, 2019

Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC…

Reason Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)

AVKARE Inc. NDC 42291-795-30 D-1122-2019

Class III · Low risk Terminated Apr 2, 2019

Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass container…

Reason Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.

Johnson Matthey Inc. D-1252-2019

Class III · Low risk Terminated Apr 1, 2019

Lemon Hand Sanitizer (Alcohol 62%), 30 mL / 1.0 fl.oz, OTC, Made in China.

Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

NingBo Huize Commodity Co.,Ltd. D-1564-2019

Class III · Low risk Terminated Apr 1, 2019

DIPPIN' DOTS SCENTED COTTON CANDY ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL…

Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

NingBo Huize Commodity Co.,Ltd. D-1563-2019

Class III · Low risk Terminated Apr 1, 2019

DIPPIN' DOTS SCENTED COOKIES 'N CREAM ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL…

Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

NingBo Huize Commodity Co.,Ltd. D-1562-2019

Class III · Low risk Terminated Apr 1, 2019

DIPPIN' DOTS SCENTED BIRTHDAY CAKE ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL…

Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

NingBo Huize Commodity Co.,Ltd. D-1561-2019

Class III · Low risk Terminated Apr 1, 2019

DIPPIN' DOTS SCENTED BANANA SPLIT ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL…

Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

NingBo Huize Commodity Co.,Ltd. D-1560-2019