FDA Recalls USDA Recalls About

FDA Recalls

Food recalls
Drug recalls
Device recalls

USDA Recalls

All USDA recalls
Poultry recalls
Meat recalls
Egg recalls

About

About us
FDA guides
USDA guides
Data sources
Privacy policy

Data

OpenFDA API
USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official sources before acting

FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 361–380 of 623 recalls

Class IIOngoing

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.

Wells Pharma of Houston LLC

cGMP deviations.

April 1, 2026 · DrugView details →

Class IIOngoing

Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.

Island Kinetics, Inc. d.b.a. CoValence Laboratories

Failed Stability Specifications

April 1, 2026 · DrugView details →

Class II

Ongoing

Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11.

Appco Pharma LLC

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

March 27, 2026 · DrugView details →

Class IIOngoing

Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.

Appco Pharma LLC

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

March 27, 2026 · DrugView details →

Class IIOngoing

Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-068-11.

Appco Pharma LLC

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

March 27, 2026 · DrugView details →

Class IIOngoing

Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10

Hetero Labs Limited (Unit V)

Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."

March 26, 2026 · DrugView details →

Class IIOngoing

Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

March 25, 2026 · DrugView details →

Class IIOngoing

Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3.

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

March 25, 2026 · DrugView details →

Class IIOngoing

Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

March 25, 2026 · DrugView details →

Class IIOngoing

Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0

Preferred Pharmaceuticals, Inc.

Lack of Assurance of Sterility

March 25, 2026 · DrugView details →

Class IIOngoing

GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.

GE Healthcare Ireland Limited

Presence of particulate matter

March 24, 2026 · DrugView details →

Class IIOngoing

Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61

The Harvard Drug Group LLC

Failed Dissolution Specifications

March 24, 2026 · DrugView details →

Class IIOngoing

GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.

GE Healthcare Ireland Limited

Presence of particulate matter

March 24, 2026 · DrugView details →

Class IIOngoing

MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-30, UPC: 383173000047.

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

March 20, 2026 · DrugView details →

Class IIOngoing

Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01

Fagron Compounding Services

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

March 20, 2026 · DrugView details →

Class IIOngoing

MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-125-25, UPC: 383173000085

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

March 20, 2026 · DrugView details →

Class IIOngoing

Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio 44256, Made in China, NDC: 83698-102-30, UPC: 093351037085.

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

March 20, 2026 · DrugView details →

Class IIOngoing

exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough Drops, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC., 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC 83698-580-30, UPC: 614299398870.

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

March 20, 2026 · DrugView details →

Class IIOngoing

Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01

Leading Pharma, LLC

CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.

March 20, 2026 · DrugView details →

Class IIOngoing

QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon Flavor, 25-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.

Xiamen Kang Zhongyuan Biotechnology Co., Ltd.

This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.

March 20, 2026 · DrugView details →

← PreviousPage 19 of 32Next →