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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 3101–3120 of 17,723 recalls

Class IITerminated

Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%)128 Fl. Oz. (1 Gal.) 3.78 liters bottles, Southern Products & Services, Inc. 2515 Jake Drive Ste B, Cumming, GA 30028

Midlab Incorporated

CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.

August 8, 2022 · DrugView details →
Class IITerminated

Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a) 1 U.S. Gallon (3.78 Liters) drums UPC 7 61841 02502 6 and b) 55 U.S. Gallon drums (208 Liters) UPC 0 07 61841 02504 0, Midlab 140 Private Brand Way, Athens, TN 37303

Midlab Incorporated

CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.

August 8, 2022 · DrugView details →
Class IIITerminated

Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4.

LNK International, Inc.

Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.

August 4, 2022 · DrugView details →
Class IIITerminated

Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ

Akron Pharma, Inc.

Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

August 4, 2022 · DrugView details →
Class IIITerminated

Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ

Akron Pharma, Inc.

Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

August 4, 2022 · DrugView details →
Class IITerminated

Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC 36000-306-60

Baxter Healthcare Corporation

Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.

August 4, 2022 · DrugView details →
Class IITerminated

Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.

CIPLA

Lack of Assurance of Sterility: Complaints received of defective container closure.

August 2, 2022 · DrugView details →
Class IIITerminated

Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only, Manufactured for Heron Therapeutics, Inc., San Diego, CA, NDC 47426-301-02

HERON THERAPEUTICS, INC.

Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit

August 2, 2022 · DrugView details →
Class IIOngoing

PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24

Akorn, Inc

Defective Container: Product has incomplete induction seals.

August 1, 2022 · DrugView details →
Class ITerminated

Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.0%, Homosalate 6.0%, Octocrylene 6.0%, packaged in Net Wt 6 oz. aluminum spray can, Distributed by: Edgewell Personal Care Brands, LLC, Shelton, CT 06484, UPC 0 79656 04041 8

Edgewell Personal Care Brands, LLC

Chemical contamination: presence of benzene

July 29, 2022 · DrugView details →
Class IITerminated

Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06

Lupin Pharmaceuticals Inc.

CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.

July 28, 2022 · DrugView details →
Class IITerminated

Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syringe, Item# 803, barcode 6919408031; b) 5 mL prefilled syringe, Item# 933, barcode 6919409331, Rx only, Pine Pharmaceuticals, 355 Riverwalk Parkway, Tonawanda, NY 14150.

Pine Pharmaceuticals, LLC

Lack of Assurance of Sterility

July 27, 2022 · DrugView details →
Class IIITerminated

Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56

Amerisource Health Services LLC

Subpotent Drug

July 27, 2022 · DrugView details →
Class IITerminated

Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10

Amneal Pharmaceuticals of New York, LLC

Failed dissolution specifications.

July 27, 2022 · DrugView details →
Class IITerminated

fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.

SterRx, LLC

Lack of Assurance of Sterility

July 25, 2022 · DrugView details →
Class IITerminated

FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.

SterRx, LLC

Lack of Assurance of Sterility

July 25, 2022 · DrugView details →
Class IITerminated

Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains 40 mg pantoprazole equivalent to 45.1 mg of pantoprazole sodium USP (sesquihydrate), Rx Only, distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, NDC 62756-071-60

SUN PHARMACEUTICAL INDUSTRIES INC

Discoloration

July 25, 2022 · DrugView details →
Class IIITerminated

Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56

Teva Pharmaceuticals USA Inc

Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.

July 22, 2022 · DrugView details →
Class ITerminated

SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC, (800) 519-0204 Miami 33172 FL, USA; UPC 0 705632 523285

Distributor RFR, LLC.

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.

July 22, 2022 · DrugView details →
Class IITerminated

Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054 USA; NDC 58544-692-30.

Teva Pharmaceuticals USA Inc

Failed Dissolution Specifications: below specification limits for dissolution.

July 21, 2022 · DrugView details →
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