Drug Recalls

1,842 drug recalls from federal enforcement feeds.

MedicalFood Drug Device

ConsumerProduct Vehicle

Showing 1,501–1,550 of 1,842

Drug Recall · April 25, 2024
FDC Limited
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distr
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Class II
Drug Recall · April 24, 2024
Coast Quality Pharmacy, LLC dba Anazao Health
Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth, 5710 Hoover Blvd, Tampa, Fl 33643, (800)-995-4363. Beyond Use Date: 09/08/2024.
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Class II
Drug Recall · April 24, 2024
Acella Pharmaceuticals, LLC
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06
Subpotent drug
Class III
Drug Recall · April 24, 2024
Aurobindo Pharma USA Inc.
Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeto
Discoloration: Dotted and yellow spots on tablets
Class II
Drug Recall · April 24, 2024
Lupin Pharmaceuticals Inc.
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II
Drug Recall · April 24, 2024
SOMERSET THERAPEUTICS LLC
Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics,
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Class II
Drug Recall · April 24, 2024
Lupin Pharmaceuticals Inc.
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II
Drug Recall · April 24, 2024
Aurobindo Pharma USA Inc.
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeto
Discoloration: Dotted and yellow spots on tablets
Class II
Drug Recall · April 23, 2024
EPI Health, LLC
Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-804-90
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II
Drug Recall · April 23, 2024
EPI Health, LLC
minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403,
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II
Drug Recall · April 23, 2024
Regeneron Pharmaceuticals Inc
EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown,
Lack of Assurance of Sterility: Complaints of syringe breakage
Class II
Drug Recall · April 23, 2024
EPI Health, LLC
minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403,
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II
Drug Recall · April 22, 2024
Stop Clopez Corp
Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV.
Marketed Without An Approved NDA/ANDA
Class I
Drug Recall · April 22, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90
Failed Release Testing: Out of specification for particulate matter test.
Class III
Drug Recall · April 20, 2024
Revive Rx LLC dba Revive Rx Pharmacy
Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Class I
Drug Recall · April 19, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Ro
Out of specification for assay
Class II
Drug Recall · April 19, 2024
Nomax Inc
FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-404-01.
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Class II
Drug Recall · April 19, 2024
Nomax Inc
FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-403-03.
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Class II
Drug Recall · April 19, 2024
Nomax Inc
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax, Inc., St. Louis, MO 63123, NDC 51801-009-40.
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Class II
Drug Recall · April 19, 2024
Nomax Inc
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 4oz (113.39g), painwizard.com Made in the USA, PO Bo
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Bottle with pump, NET WT 16 fluid oz / 473.17 ml, Made in USA, ww
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump Capsaicin, Aloe Vera, Willow Bark & MSM, Bottle with Pump NET WT 32 fl. oz (946.33ml), Manufactured for Golden Ti
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Tube 4 oz (113.39 g), Mfr. for Golden Tiger USA Albuq, NM, UPC 1 82294 00002
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Gallon Jug 128 fl. oz. (3776 ml), Manufactured for Golden Tiger LLC, Made in
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 1 OZ (28 g), Manufac
Out of Specification for active ingredient
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Roll-On NET WT 3 fl. oz. (88.7ml), Manufactured for Golden Tiger USA Albuquer
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 8 oz (226.79g), Made in the USA, painwizard.com PO
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 4 OZ (113g), Manufactured for AGS Brand
Out of Specification for active ingredient
Class II
Drug Recall · April 17, 2024
Glenmark Pharmaceuticals Inc., USA
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of
Failed Dissolution Specifications
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB Protection, NEW WT. 5 FL OZ (148ML), Distributed by: Bullfrog Brands LLC, PO Bo
Out of Specification for active ingredient
Class II
Drug Recall · April 17, 2024
ARG Laboratories, Inc.
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Roll-On 3 fl oz (88.7ml), painwizard.com Made in the USA, PO Box
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II
Drug Recall · April 12, 2024
Dercher Enterprises, Inc., DBA Gordon Laboratories
Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01
cGMP Deviations
Class II
Drug Recall · April 10, 2024
Imprimis NJOF, LLC
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-34
Subpotent Drug
Class II
Drug Recall · April 10, 2024
Imprimis NJOF, LLC
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01
Out of specification for assay
Class III
Drug Recall · April 9, 2024
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.
Cross Contamination with Other Products
Class III
Drug Recall · April 9, 2024
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13
Cross Contamination with Other Products
Class III
Drug Recall · April 9, 2024
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13
Cross Contamination with Other Products
Class III
Drug Recall · April 9, 2024
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13
Cross Contamination with Other Products
Class III
Drug Recall · April 8, 2024
Dr. Reddy's Laboratories, Inc.
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 435
Sub-potent Drug; powder discoloration associated with decreased potency
Class I
Drug Recall · April 8, 2024
Dr. Reddy's Laboratories, Inc.
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
Sub-potent Drug; powder discoloration associated with decreased potency
Class I
Drug Recall · April 2, 2024
X-Gen Pharmaceuticals Inc.
Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Class III
Drug Recall · April 2, 2024
X-Gen Pharmaceuticals Inc.
Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Class III
Drug Recall · March 29, 2024
HONEYWELL INC
Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face Protection, Inc., 825 East Highway 151, Platteville, WI 53818. NDC: 0498-0631-
CGMP Deviations
Class II
Drug Recall · March 28, 2024
Teva Pharmaceuticals USA, Inc
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 05
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Class II
Drug Recall · March 28, 2024
AvKARE
Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Class I
Drug Recall · March 27, 2024
NATCO Pharma Limited
Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by:
CGMP Deviations
Class II
Drug Recall · March 27, 2024
Esperion
NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Class III
Drug Recall · March 26, 2024
Glenmark Pharmaceuticals Inc., USA
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Class II
Drug Recall · March 26, 2024
Cipla USA, Inc.
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Ci
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Class II