Class II · Moderate risk Ongoing
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
Reason cGMP deviations.
FDA Drug Recalls
457 recalls, newest first
Class II · Moderate risk Ongoing
Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.
Reason Failed Stability Specifications
Class II · Moderate risk Ongoing
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An…
Reason Lack of Assurance of Sterility
Class III · Low risk Ongoing
Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance…
Reason Subpotent drug
Class II · Moderate risk Ongoing
Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ…
Reason cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Class II · Moderate risk Ongoing
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ…
Reason cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Class II · Moderate risk Ongoing
Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ…
Reason cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Class II · Moderate risk Ongoing
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals…
Reason Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Class II · Moderate risk Ongoing
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist…
Reason Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class II · Moderate risk Ongoing
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist…
Reason Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class II · Moderate risk Ongoing
Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist…
Reason Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class II · Moderate risk Ongoing
Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed…
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA…
Reason Presence of particulate matter
Class II · Moderate risk Ongoing
GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA…
Reason Presence of particulate matter
Class I · High risk Ongoing
Kian Pee Wan Capsules, 30-count bottles
Reason Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
Class II · Moderate risk Ongoing
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC…
Reason CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Class II · Moderate risk Ongoing
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag, Distributed By…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Distributed By: CDMA…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey Lemon Flavor, 30-count bag, Distributed By: CDMA…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Strawberry Flavor, 30-count bag, Distributed By: CDMA…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon Flavor, 25-count bag…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag, Distributed By: CDMA…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free, Black Cherry Flavor, 25-count bag…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, Distributed By: Medical Group…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…