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.

2020-02-19FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class I
Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
2020-02-12FDA-DrugMacleods Pharma Usa IncClass III
Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
2020-02-12FDA-DrugGraviti Pharmaceuticals Private LimitedClass II
Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11.
Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
2020-02-12FDA-DrugTeva Pharmaceuticals USAClass II
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2465-01
GMP Deviations: Product bottle may be absent of desiccant.
2020-02-12FDA-DrugTeva Pharmaceuticals USAClass II
Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2464-01
GMP Deviations: Product bottle may be absent of desiccant.
2020-02-12FDA-DrugUNICHEM PHARMACEUTICALS USA INCClass III
Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilerne Ind. Estate, Pilerne Bardez, Goa 403 511 India. Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816. NDC 29300-135-01
Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.
2020-02-12FDA-DrugAscend Laboratories LLCClass II
Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90.
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
2020-02-12FDA-DrugAscend Laboratories LLCClass III
Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30.
Failed Dissolution Specifications: low out of specification results for dissolution testing.
2020-02-12FDA-DrugPD-Rx Pharmaceuticals, Inc.Class II
ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
2020-02-12FDA-DrugSpectrum Laboratory ProductsClass II
Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram
CGMP Deviations: Presence of NDMA impurity detected in product.
2020-02-05FDA-DrugPharmaceutical Associates IncClass II
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16
Subpotent: Out of specification for assay at the 12-month time point.
2020-02-05FDA-DrugMacleods Pharma Usa IncClass III
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
2020-02-05FDA-DrugShandex Personal Care Manufacturing Inc.Class II
Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, NDC: 0363-0137-11
Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing).
2020-02-05FDA-DrugMcGuff Compounding Pharmacy Services, Inc.Class II
Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Pharmacy Services, Inc. Santa Ana, CA 92704
Presence of Particulate Matter: Particulates observed in vials release for dispensing.
2020-02-05FDA-DrugMPRX, Inc. dba Medical Park PharmacyClass II
Testosterone Topical Cream 4%
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
2020-02-05FDA-DrugMPRX, Inc. dba Medical Park PharmacyClass II
Tadalafil 6 mg Capsule
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
2020-02-05FDA-DrugMPRX, Inc. dba Medical Park PharmacyClass II
Tadalafil 20 mg Troche
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
2020-02-05FDA-DrugMPRX, Inc. dba Medical Park PharmacyClass II
T3/T4 SR 9 mcg/38 mcg capsule
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
2020-02-05FDA-DrugMPRX, Inc. dba Medical Park PharmacyClass II
Squaric Acid 0.1% Topical Solution (Clinic) 30 mL
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
2020-02-05FDA-DrugMPRX, Inc. dba Medical Park PharmacyClass II
Sildenafil 80 mg capsules
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
2020-02-05FDA-DrugMPRX, Inc. dba Medical Park PharmacyClass II
Sildenafil 200 mg Troche (Clinic)
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
2020-02-05FDA-DrugMPRX, Inc. dba Medical Park PharmacyClass II
Progesterone E4M SR 100 mg capsules
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
2020-02-05FDA-DrugMPRX, Inc. dba Medical Park PharmacyClass II
Progesterone 50 mg capsules
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
2020-02-05FDA-DrugMPRX, Inc. dba Medical Park PharmacyClass II
Progesterone 200 mg Troche
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
2020-02-05FDA-DrugMPRX, Inc. dba Medical Park PharmacyClass II
Naltrexone 4.5 mg capsule
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
2020-02-05FDA-DrugMPRX, Inc. dba Medical Park PharmacyClass II
Magic Bullet Supplement
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
2020-02-05FDA-DrugMPRX, Inc. dba Medical Park PharmacyClass II
Liothyronine (T3) 92.5 MCG
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
2020-02-05FDA-DrugMPRX, Inc. dba Medical Park PharmacyClass II
Liothyronine (T3) 80 mcg SR cap
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
2020-02-05FDA-DrugMPRX, Inc. dba Medical Park PharmacyClass II
Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
2020-02-05FDA-DrugMPRX, Inc. dba Medical Park PharmacyClass II
Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.

← prevpage 205/588next →

Get notified about new drug recalls

Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.

Get the Sunday Brief

Get notified about new drug recalls

Explore other recall topics