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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 161–180 of 1,000 recalls

Class IIOngoing

Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton)

Huons Co., Ltd.

Lack of Assurance of Sterility

April 2, 2026 · DrugView details →
Class IIOngoing

Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.

Wells Pharma of Houston LLC

cGMP deviations.

April 1, 2026 · Drug
View details →
Class IIOngoing

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.

Wells Pharma of Houston LLC

cGMP deviations.

April 1, 2026 · DrugView details →
Class IIOngoing

fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.

Wells Pharma of Houston LLC

cGMP deviations.

April 1, 2026 · DrugView details →
Class IIOngoing

EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1

International Medication Systems Ltd.

Lack of Assurance of Sterility

April 1, 2026 · DrugView details →
Class IIOngoing

fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.

Wells Pharma of Houston LLC

cGMP deviations.

April 1, 2026 · DrugView details →
Class IIOngoing

fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.

Wells Pharma of Houston LLC

cGMP deviations.

April 1, 2026 · DrugView details →
Class IIOngoing

Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03

Wells Pharma of Houston LLC

cGMP deviations.

April 1, 2026 · DrugView details →
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 IIOngoing

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 →
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