Drug Recalls

1,822 drug recalls from federal enforcement feeds.

MedicalFood Drug Device

ConsumerProduct Vehicle

Showing 1–50 of 1,822

Drug Recall · June 22, 2026
Direct Rx
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II
Drug Recall · June 17, 2026
SUN PHARMACEUTICAL INDUSTRIES INC
Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Class II
Drug Recall · June 16, 2026
The Harvard Drug Group LLC
Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, in 46268, NDC 0904-7282-10. Blister
Subpotent Drug
Class II
Drug Recall · June 12, 2026
Par Health USA, LLC
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05
Crystallization; identified as Buprenorphine free base
Class II
Drug Recall · June 5, 2026
Inventia Healthcare Limited
Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distribut
Failed Dissolution Specifications
Class II
Drug Recall · June 4, 2026
Amgen, Inc.
Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy.
Presence of Foreign Substance.
Class II
Drug Recall · June 4, 2026
Haleon US Holdings LLC
Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Class I
Drug Recall · June 4, 2026
Elevate Oral Care
Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1.
sub potency
Class II
Drug Recall · June 4, 2026
Annora Pharma Private Limited
Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854,
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Class II
Drug Recall · June 4, 2026
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelo
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II
Drug Recall · June 4, 2026
Amgen, Inc.
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60
Presence of Foreign Substance.
Class II
Drug Recall · June 4, 2026
Amgen, Inc.
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30
CGMP Deviations
Class II
Drug Recall · June 4, 2026
Amgen, Inc.
Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30
CGMP Deviations
Class II
Drug Recall · June 4, 2026
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmace
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II
Drug Recall · June 4, 2026
Amgen, Inc.
Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30
CGMP Deviations
Class II
Drug Recall · June 3, 2026
Amneal Pharmaceuticals, LLC
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceutic
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Class III
Drug Recall · June 2, 2026
Dabur India Limited
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: Pharmadel LLC, New Cast
CGMP Deviations; deficiencies observed during FDA inspection
Class II
Drug Recall · June 2, 2026
Dabur India Limited
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0.
CGMP Deviations; deficiencies observed during FDA inspection
Class II
Drug Recall · June 2, 2026
Dabur India Limited
Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LKT.
CGMP Deviations; deficiencies observed during FDA inspection
Class II
Drug Recall · June 2, 2026
Dabur India Limited
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 5000 units, 0.9g packets, 144 packets per box, 130g, Manufactured for: Shield Line
CGMP Deviations; deficiencies observed during FDA inspection
Class II
Drug Recall · June 2, 2026
Dabur India Limited
Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate 5000 units, Net Wt. 0.5 oz (14g) tubes, Manufactured for Delta Brands
CGMP Deviations; deficiencies observed during FDA inspection
Class II
Drug Recall · June 2, 2026
Dabur India Limited
Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India
CGMP Deviations; deficiencies observed during FDA inspection
Class II
Drug Recall · June 2, 2026
Dabur India Limited
Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8.
CGMP Deviations; deficiencies observed during FDA inspection
Class II
Drug Recall · June 2, 2026
Dabur India Limited
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 305061.
CGMP Deviations; deficiencies observed during FDA inspection
Class II
Drug Recall · June 2, 2026
Dabur India Limited
Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g), Product distributed by: Lil' Drug Store Pr
CGMP Deviations; deficiencies observed during FDA inspection
Class II
Drug Recall · June 2, 2026
Dabur India Limited
Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2.
CGMP Deviations; deficiencies observed during FDA inspection
Class II
Drug Recall · June 2, 2026
Central Admixture Pharmacy Services, Inc.
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central
Incorrect product formulation: bag did not contain copper and famotidine per label.
Class II
Drug Recall · June 2, 2026
Dabur India Limited
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 U
CGMP Deviations; deficiencies observed during FDA inspection
Class II
Drug Recall · June 2, 2026
ANI Pharmaceuticals, Inc.
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10
Presence of foreign substance
Class III
Drug Recall · June 2, 2026
Dabur India Limited
Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store P
CGMP Deviations; deficiencies observed during FDA inspection
Class II
Drug Recall · June 2, 2026
Dabur India Limited
Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1.
CGMP Deviations; deficiencies observed during FDA inspection
Class II
Drug Recall · June 2, 2026
Dabur India Limited
Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30352 4.
CGMP Deviations; deficiencies observed during FDA inspection
Class II
Drug Recall · June 1, 2026
BEEKEEPER'S NATURALS USA INC.
BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA Inc., Covina, CA 91789.
Microbial Contamination of Non-Sterile Products
Class I
Drug Recall · June 1, 2026
Sandoz Inc
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III
Drug Recall · June 1, 2026
Ascend Laboratories, LLC
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 070
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Class II
Drug Recall · June 1, 2026
BEEKEEPER'S NATURALS USA INC.
BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA Inc., Covina, CA 91723
Microbial Contamination of Non-Sterile Products
Not Yet Classified
Drug Recall · May 29, 2026
Golden State Medical Supply Inc.
GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged b
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Class II
Drug Recall · May 29, 2026
SUN PHARMACEUTICAL INDUSTRIES INC
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96 Chewable Tablets, MADE WITH PRIDE & CARE FOR H.E.B, 646 S. FLORES ST, SAN ANTONIO, TX, NDC 37808-136-22.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets, Distributed by: Drug Mart- Food Fair Medina, OH 44256, UPC: 0 93351 03992 8.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA., NDC 55319-171-68.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-171-68.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
CareFusion 213, LLC
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82497 1.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-178-23.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
Ajanta Pharma USA Inc
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04.
CGMP Deviations
Class II
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count bottle, Haleon, Warren, NJ 07059, UPC 3 0766 3072 10 9.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II
Drug Recall · May 28, 2026
CareFusion 213, LLC
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79
Non-Sterility: Due to presence of Aspergillus penicillioides.
Class I
Drug Recall · May 28, 2026
Guardian Drug Co. Inc.
TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-128-22.
Presence of foreign substance: small metallic particles in chewable tablets.
Class II