Drug and pharmaceutical recalls

17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2020-01-15FDA-DrugIdelle LabsClass III
SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deodorant Net Wt 2.6 oz (73g) NDC# 41595-5547-1 UPC 8 83484 31020 5 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
2020-01-15FDA-DrugIdelle LabsClass III
SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, Net Wt. 2.6 oz (73g) NDC# 41595-5509-2 UPC 8 83484 71717 2 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
2020-01-15FDA-DrugAsclemed USA Inc. dba Enovachem PharmaceuticalsClass II
Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
2020-01-15FDA-DrugAsclemed USA Inc. dba Enovachem PharmaceuticalsClass II
Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
2020-01-15FDA-DrugAsclemed USA Inc. dba Enovachem PharmaceuticalsClass II
Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
2020-01-15FDA-DrugAppco Pharma LLCClass II
Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
2020-01-15FDA-DrugAppco Pharma LLCClass II
Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
2020-01-15FDA-DrugAAA Pharmaceutical, Inc.Class II
Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
2020-01-15FDA-DrugAAA Pharmaceutical, Inc.Class II
Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
2020-01-15FDA-DrugGlenmark Pharmaceuticals Inc., USAClass II
Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-05
CGMP Deviations: Presence of NDMA impurity detected in product.
2020-01-15FDA-DrugGlenmark Pharmaceuticals Inc., USAClass II
Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-20
CGMP Deviations: Presence of NDMA impurity detected in product.
2020-01-15FDA-DrugGlenmark Pharmaceuticals Inc., USAClass II
Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01
CGMP Deviations: Presence of NDMA impurity detected in product.
2020-01-15FDA-DrugGlenmark Pharmaceuticals Inc., USAClass II
Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30
CGMP Deviations: Presence of NDMA impurity detected in product.
2020-01-15FDA-DrugGlenmark Pharmaceuticals Inc., USAClass II
Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-01
CGMP Deviations: Presence of NDMA impurity detected in product.
2020-01-15FDA-DrugGlenmark Pharmaceuticals Inc., USAClass II
Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60
CGMP Deviations: Presence of NDMA impurity detected in product.
2020-01-15FDA-DrugLupin Pharmaceuticals Inc.Class II
Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for: Lupin Limited Pithampur 454775 INDIA 240875, NDC 68180-866-11
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
2020-01-08FDA-DrugAkorn, Inc.Class II
MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forset, IL 60045; NDC 61748-302-13.
Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.
2020-01-08FDA-DrugLupin Pharmaceuticals Inc.Class III
Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
2020-01-08FDA-DrugIsland Kinetics, Inc. d.b.a. CoValence LaboratoriesClass III
PCA Skin Blemish Control Bar, 3.2 oz/90g, Salicylic acid 2% - Acne cleanser, For external use only, Distributed by PCA Skin, 6210 E. Thomas Rd., Ste. 200, Scottsdale, AZ 85251; UPC 812025010397.
Superpotent Drug: Salicylic acid content is above the firm's specification.
2020-01-08FDA-DrugNatures RxClass I
Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 male enhancement capsules in blister foil package, 725mg per capsule, Distributed by Silver Bullet Ltd, Golden Springs, CO, USA, UPC: 610877392698.
Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
2020-01-08FDA-DrugGranules India LimitedClass II
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
2020-01-08FDA-DrugAmerican Health PackagingClass II
Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)
CGMP Deviations: Presence of NDMA impurity detected in product.
2020-01-01FDA-DrugSpectrum Laboratory ProductsClass II
Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G glass bottles, b) 5 G glass bottles, c) 25 G glass bottles, d) 100 G glass bottles, e) 500 G glass bottles, and f) 1 KG plastic bottles, Rx Only, Spectrum Chemical Mfg Corp., Gardena, CA 90248.
Subpotent Drug: Supplier indicated assay results did not meet specifications.
2020-01-01FDA-DrugPharmedium Services, LLCClass III
NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 254.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
Subpotent Drug
2020-01-01FDA-DrugPharmedium Services, LLCClass III
NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
Subpotent Drug
2020-01-01FDA-DrugPharmedium Services, LLCClass III
NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
Subpotent Drug
2019-12-25FDA-DrugAuroMedics Pharma LLCClass II
Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99
Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
2019-12-25FDA-DrugLannett Company, Inc.Class I
Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80
Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
2019-12-25FDA-DrugLupin Pharmaceuticals Inc.Class III
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA
Failed Dissolution Specifications: High out of specification result observed at stability studies.
2019-12-25FDA-DrugApothecus Pharmaceutical Corp.Class III
VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g). NDC 52925-312-14, b) case pack with 36 cans in a nested container. Net wt 0.6 oz (17g) per can. NDC 52925-312-06, Distributed By: Apothecus Pharmaceutical Corp. Oyster Bay, NY 11771.
Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable

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