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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 301–320 of 1,000 recalls

Class IIITerminated

Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured by Hi-Tech Pharmacal Co Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01

Leadiant Biosciences, Inc.

Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.

September 24, 2020 · DrugView details →
Class IIITerminated

Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, Distributed by: Wal-Mart, Bentonville, AR 72716. NDC 68645-545-59

Legacy Pharmaceutical Packaging LLC

Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.

September 24, 2020 · Drug
View details →
Class IIITerminated

Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologicals, Inc. 469 W. Parkland Drive Sandy, UT 84070. NDC 43742-0756-1.

Grato Holdings, Inc.

Labeling: Product Contains Undeclared API; Incorrect formulation

September 17, 2020 · DrugView details →
Class IIITerminated

Nymalize (nimodipine) oral solution, 60 mg/20 mL, 12 Unit-Dose Cups and 12 Oral Syringes, 2 inner cartons per outer shipping carton, Rx Only, Distributed by arbor Atlanta, GA, NDC 24338-200-12

Arbor Pharmaceuticals Inc.

Subpotent Drug

September 16, 2020 · DrugView details →
Class IIITerminated

Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-3328-3.

P & L Developments, LLC

Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.

September 9, 2020 · DrugView details →
Class IIITerminated

Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40

PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint

September 9, 2020 · DrugView details →
Class IIITerminated

Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

August 3, 2020 · DrugView details →
Class IIITerminated

Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139,

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

August 3, 2020 · DrugView details →
Class IIITerminated

Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets box packaged in a blister pack, Distributed by: Mentholatum Company, Orchard Park, NY 14127 NDC 10742-8902-1, UPC 3 10742 09509 8

The Mentholatum Company

Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.

July 31, 2020 · DrugView details →
Class IIITerminated

Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-902-15) and b) 45g Tubes (NDC 60429-902-45), Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada, Marketed by: Golden State Medical Supply Inc. Camarillo, CA 93012.

Golden State Medical Supply Inc.

Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.

July 24, 2020 · DrugView details →
Class IIITerminated

Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724, NDC 0054-4497-10

West-Ward Columbus Inc

Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.

July 22, 2020 · DrugView details →
Class IIITerminated

Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Marketed by: Golden State Medical Supply, Inc. Camarillo, CA 93012.

Taro Pharmaceuticals U.S.A., Inc.

Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.

July 20, 2020 · DrugView details →
Class IIITerminated

Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10

Fresenius Kabi USA, LLC

Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.

July 13, 2020 · DrugView details →
Class IIITerminated

Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying Toner (Salicylic Acid 2.0%), 6 fl oz,; Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 fl oz., Distributed in the U.S.A. by Allergan, Irvine, CA 92612, UPC 300234966005

Allergan PLC

SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.

July 6, 2020 · DrugView details →
Class IIITerminated

Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, CA 92612, NDC 0023-4965-02

Allergan PLC

SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.

July 6, 2020 · DrugView details →
Class IIITerminated

Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86

SUN PHARMACEUTICAL INDUSTRIES INC

Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine

July 6, 2020 · DrugView details →
Class IIITerminated

Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02

Biogen MA Inc.

cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.

June 23, 2020 · DrugView details →
Class IIITerminated

Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.

VistaPharm, Inc.

Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.

June 23, 2020 · DrugView details →
Class IIITerminated

Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.

VistaPharm, Inc.

Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.

June 23, 2020 · DrugView details →
Class IIITerminated

Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Distributed by HF Acquisition Co, LLC, Mukilteo, WA 98275, NDC 63323-739-12

HF Acquisition Co. LLC

TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.

June 17, 2020 · DrugView details →
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