Browse Drug Recalls
2,149 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,149 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 2,149 FDA drug recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| May 28, 2026 | CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewabl... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS... | 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, 1000 mg, 160-c... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 18, 2026 | Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose ... | Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan | Class III | Eugia US LLC |
| May 11, 2026 | Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, War... | Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labe... | Class II | Haleon US Holdings LLC |
| May 5, 2026 | Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bott... | Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications | Class II | Ascend Laboratories, LLC |
| Apr 29, 2026 | Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactur... | CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable in... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Apr 29, 2026 | Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactur... | CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable in... | Class II | Zydus Pharmaceuticals (USA) Inc |
| Apr 27, 2026 | Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP,... | Failed Dissolution Specifications | Class II | Ascend Laboratories, LLC |
| Apr 24, 2026 | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... | Class II | Teva Pharmaceuticals USA, Inc |
| Apr 21, 2026 | Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr... | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit | Class II | Breckenridge Pharmaceutical, Inc. |
| Apr 13, 2026 | busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufa... | Subpotent drug | Class III | Unichem Pharmaceuticals USA Inc. |
| Apr 6, 2026 | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton,... | Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 27, 2026 | Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufac... | cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im... | Class II | Appco Pharma LLC |
| Mar 27, 2026 | Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufa... | cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im... | Class II | Appco Pharma LLC |
| Mar 27, 2026 | Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufac... | cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im... | Class II | Appco Pharma LLC |
| Mar 25, 2026 | Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceutica... | Failed Viscosity Specifications: Out of Specification results, above the specification limit, in... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 25, 2026 | Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceutica... | Failed Viscosity Specifications: Out of Specification results, above the specification limit, in... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 25, 2026 | Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceutica... | Failed Viscosity Specifications: Out of Specification results, above the specification limit, in... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 20, 2026 | Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by... | CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. | Class II | Leading Pharma, LLC |
| Mar 19, 2026 | Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Syste... | CGMP Deviations: use of an unapproved raw material | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 19, 2026 | Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Syste... | CGMP Deviations: use of an unapproved raw material | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 19, 2026 | Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Syste... | CGMP Deviations: use of an unapproved raw material | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 19, 2026 | traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manu... | Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was f... | Class II | Amneal Pharmaceuticals, LLC |
| Mar 18, 2026 | Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further... | Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actua... | Class I | Amneal Pharmaceuticals, LLC |
| Mar 17, 2026 | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 17, 2026 | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 17, 2026 | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 16, 2026 | Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit | Class II | Cipla USA, Inc. |
| Mar 16, 2026 | Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit | Class II | Cipla USA, 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.