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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).

Jun 16, 2025 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-15

ACCORD HEALTHCARE

Class I - Dangerous

Subpotent Drug: Assay below the approved specification

Jun 20, 2025 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-456-17

ACCORD HEALTHCARE

Class I - Dangerous

Subpotent Drug: Assay below the approved specification

Jun 20, 2025 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17

ACCORD HEALTHCARE

Class I - Dangerous

Subpotent Drug: Assay below the approved specification

Jun 20, 2025 Prescription Drugs Nationwide View Details →

Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-039-00, UPC Code 815195018194

A.P. Deauville

Class I - Dangerous

CGMP Deviations

Jul 10, 2025 Other Drugs Nationwide View Details →

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17

ACCORD HEALTHCARE

Class I - Dangerous

Subpotent Drug: Assay below the approved specification

Jun 20, 2025 Prescription Drugs Nationwide View Details →

Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-040-00 UPC Code 815195018224

A.P. Deauville

Class I - Dangerous

CGMP Deviations

Jul 10, 2025 Other Drugs Nationwide View Details →

Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18

Ascend Laboratories

Class I - Dangerous

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

Jul 9, 2025 Prescription Drugs Nationwide View Details →

Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17

ACCORD HEALTHCARE

Class I - Dangerous

Subpotent Drug: Assay below the approved specification

Jun 20, 2025 Prescription Drugs Nationwide View Details →

GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free, Biodegradable, Chemical Free, Non-Nano, Baby Safe, Original, SPF 32, Totally Green personal care, Zinc Oxide USP 25%, 3.4 FL OZ/115 G Tube, NDC: 73369-0001-1

KABANA SKIN CARE

Class I - Dangerous

cGMP deviations

Mar 12, 2025 Other Drugs View Details →

Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA for Erin's Faces, Millburn, NO 07041. NDC: 73369-1401-1

KABANA SKIN CARE

Class I - Dangerous

cGMP deviations

Mar 12, 2025 Other Drugs View Details →

Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07.

Macleods Pharmaceuticals

Class I - Dangerous

Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.

Jun 11, 2025 Prescription Drugs Nationwide View Details →

Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.

Breckenridge Pharmaceutical

Class I - Dangerous

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Jun 30, 2025 Prescription Drugs Nationwide View Details →

B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1002-2; b) Tint Free Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1001-2; c) Tan Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1003-2.

KABANA SKIN CARE

Class I - Dangerous

cGMP deviations

Mar 12, 2025 Other Drugs View Details →

In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spectrum UVA & UVB chemical free, Organic Ingredients, Biodegradable & Baby Safe, 50 mL - 1.7 fl oz per bottle, Manufactured for IN YOUR FACE Skin Care, Belleair Bluffs, FL, Made in USA, NDC: 73369-1601-1

KABANA SKIN CARE

Class I - Dangerous

cGMP deviations

Mar 12, 2025 Other Drugs View Details →

Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2.

Church & Dwight

Class I - Dangerous

Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.

Jun 6, 2025 Other Drugs Nationwide View Details →

Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).

Sandoz

Class I - Dangerous

Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin

Jun 27, 2025 Prescription Drugs Nationwide View Details →

Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90

AvKARE

Class I - Dangerous

Failed Impurity/Degradation Specifications

Jun 26, 2025 Prescription Drugs Nationwide View Details →

Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3631-98.

Orient Pharma Co., Ltd. Yunlin Plant

Class I - Dangerous

Failed Impurities/Degradation Specifications.

Jun 11, 2025 Prescription Drugs View Details →

KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-0006-0.

Tailstorm Health

Class I - Dangerous

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Jun 2, 2025 Prescription Drugs Nationwide View Details →