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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.