Browse Drug Recalls

2,191 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,191 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 2,191 FDA drug recalls in NJ.

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DateProductReasonClassFirm
Aug 10, 2026 Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus,... CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for micro... Class II Church & Dwight Co., Inc.
Aug 6, 2026 Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx ... Presence of particulate matter: glass and stopper piece Class II Mallinckrodt Hospital Products Inc.
Aug 5, 2026 Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufac... CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. Class II Zydus Pharmaceuticals (USA) Inc
Aug 4, 2026 Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manu... Failed Dissolution Specifications Class II Novartis Pharmaceuticals Corporation
Aug 3, 2026 Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured ... CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jul 30, 2026 CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx On... Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles. Class II Heritage Pharmaceuticals Inc
Jul 23, 2026 Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distri... shortfill; reports of empty capsules. Class II Aurobindo Pharma USA Inc
Jul 23, 2026 Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distribu... CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described... Class II Glenmark Pharmaceuticals Inc., USA
Jul 22, 2026 Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL -... Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops. Class II MICRO LABS USA INC
Jul 16, 2026 Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further p... Failed impurity/degradation specification: an OOS result observed in Related substance test analy... Class III Ascend Laboratories, LLC
Jul 16, 2026 Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further pa... Failed impurity/degradation specification: an OOS result observed in Related substance test analy... Class III Ascend Laboratories, LLC
Jul 16, 2026 Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further pac... Failed impurity/degradation specification: an OOS result observed in Related substance test analy... Class III Ascend Laboratories, LLC
Jul 13, 2026 Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx o... Presence of Precipitate: medication was crystallizing and particles floating in the bottle Class II Rising Pharma Holding, Inc.
Jul 8, 2026 Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bott... Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications Class II Ascend Laboratories, LLC
Jun 30, 2026 Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manuf... Failed Impurities/Degradation Specifications: OOS result was observed during the related substanc... Class III Ascend Laboratories, LLC
Jun 30, 2026 Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manuf... Failed Impurities/Degradation Specifications: OOS result was observed during the related substanc... Class III Ascend Laboratories, LLC
Jun 29, 2026 Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactur... cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Class II Cipla USA, Inc.
Jun 29, 2026 Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactur... cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Class II Cipla USA, Inc.
Jun 29, 2026 Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactur... cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Class II Cipla USA, Inc.
Jun 26, 2026 Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, ... Presence of Foreign Tablets/Capsules Class II Bionpharma Inc.
Jun 17, 2026 Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutica... Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 4, 2026 Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc.
Jun 4, 2026 Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (N... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc.
Jun 4, 2026 Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels... Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machin... Class I Haleon US Holdings LLC
Jun 3, 2026 Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured ... Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetac... Class III Amneal Pharmaceuticals, LLC
Jun 1, 2026 Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets pe... Failed Impurities/Degradation Specifications Class III SUN PHARMACEUTICAL INDUSTRIES INC
Jun 1, 2026 Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bo... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Sandoz Inc
Jun 1, 2026 Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bot... Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9... Class II Ascend Laboratories, LLC
May 29, 2026 Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampu... Presence of Foreign Substance:This recall has been initiated in response to a product quality com... Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 28, 2026 Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Aja... CGMP Deviations Class II Ajanta Pharma USA Inc
May 28, 2026 KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-c... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 7... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 750 mg, chew... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets, Calcium Carbonate 750 ... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, ... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 7... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 ... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets, 96-count b... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 ... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewabl... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewa... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewab... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewab... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-co... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chew... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS,... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.

Frequently Asked Questions

When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.