Browse Drug Recalls

2,097 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,097 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 2,097 FDA drug recalls in NJ.

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Date	Product	Reason	Class	Firm
Dec 20, 2018	Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, ...	Failed Dissolution Specifications	Class III	Amerigen Pharmaceuticals Inc.
Dec 20, 2018	OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic ap...	GMP Deviations: A silicone particulate was noted in Ozurdex.	Class II	Allergan, PLC.
Dec 10, 2018	Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx...	Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification ...	Class II	Dr. Reddy's Laboratories, Inc.
Dec 7, 2018	Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes,...	GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purif...	Class II	US Pharmaceuticals Inc.
Dec 7, 2018	Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Pa...	Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained dur...	Class III	Sun Pharmaceutical Industries, Inc.
Dec 7, 2018	Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) pa...	GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purif...	Class II	US Pharmaceuticals Inc.
Dec 7, 2018	Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz ...	GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purif...	Class II	US Pharmaceuticals Inc.
Nov 30, 2018	Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bo...	Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets f...	Class III	Aurobindo Pharma USA Inc.
Nov 27, 2018	Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufa...	Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule...	Class III	Glenmark Pharmaceuticals Inc., USA
Nov 26, 2018	Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ...	Superpotent Drug: recalled lots may have higher concentration of ibuprofen.	Class II	Tris Pharma Inc.
Nov 26, 2018	Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ...	Superpotent Drug: recalled lots may have higher concentration of ibuprofen.	Class II	Tris Pharma Inc.
Nov 26, 2018	infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 m...	Superpotent Drug: recalled lots may have higher concentration of ibuprofen.	Class II	Tris Pharma Inc.
Nov 14, 2018	Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by:...	Presence of Foreign Substance; metal shard found in tablet	Class II	Ascend Laboratories LLC
Nov 8, 2018	INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx ...	Failed Stability Specification: out of specification for iron content.	Class II	ALLERGAN
Nov 7, 2018	Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx...	Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 1...	Class II	Dr. Reddy's Laboratories, Inc.
Nov 2, 2018	Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufacture...	Cross Contamination with Other Products	Class II	Sandoz Inc
Nov 2, 2018	Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distribu...	Cross Contamination with Other Products	Class II	Sandoz Inc
Nov 2, 2018	Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactur...	Cross Contamination with Other Products	Class II	Sandoz Inc
Nov 2, 2018	Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactur...	Cross Contamination with Other Products	Class II	Sandoz Inc
Nov 2, 2018	Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bo...	Cross Contamination with Other Products	Class III	Sandoz Inc
Nov 2, 2018	Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in ...	Cross Contamination with Other Products	Class III	Sandoz Inc
Nov 1, 2018	Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, ...	CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i...	Class II	Sandoz, Inc
Oct 26, 2018	Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), F...	Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and ...	Class I	Dr. Reddy's Laboratories, Inc.
Oct 23, 2018	Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg,...	Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser cont...	Class II	Janssen Pharmaceuticals, Inc.
Oct 23, 2018	Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28...	Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser cont...	Class II	Janssen Pharmaceuticals, Inc.
Oct 15, 2018	Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only,...	Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle	Class II	Heritage Pharmaceuticals, Inc.
Oct 5, 2018	Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05)...	Failed dissolution specifications: Out-of-Specification dissolution results obtained during stabi...	Class III	Amerigen Pharmaceuticals Inc.
Oct 5, 2018	Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured...	Failed Impurities/Degradation Specifications:Out of specification result noticed for total impuri...	Class II	LUPIN SOMERSET
Sep 21, 2018	Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, ...	Failed stability specifications - An out of specification result was observed for the test parame...	Class II	Dr. Reddy's Laboratories, Inc.
Sep 18, 2018	Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 m...	Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging com...	Class III	Xiromed LLC
Sep 17, 2018	treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for...	Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabel...	Class III	Otsuka Pharmaceutical Development & Commerciali...
Sep 17, 2018	treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for ...	Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabel...	Class III	Otsuka Pharmaceutical Development & Commerciali...
Sep 12, 2018	Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd B...	Failed Impurities/Degradation Specifications: OOS for unknown impurities.	Class III	Dr. Reddy's Laboratories, Inc.
Sep 12, 2018	Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bot...	Failed Impurities/Degradation Specifications: OOS for unknown impurities.	Class III	Dr. Reddy's Laboratories, Inc.
Sep 4, 2018	Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Red...	Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl T...	Class II	Dr. Reddy's Laboratories, Inc.
Aug 24, 2018	Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. ...	CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products ...	Class II	Valeant Pharmaceuticals North America LLC
Aug 24, 2018	Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Di...	CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products ...	Class II	Valeant Pharmaceuticals North America LLC
Aug 24, 2018	Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) ...	CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products ...	Class II	Valeant Pharmaceuticals North America LLC
Aug 23, 2018	Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, ...	Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being...	Class III	LUPIN SOMERSET
Aug 17, 2018	Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Torrent Pharma Inc.
Aug 17, 2018	Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 m...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Torrent Pharma Inc.
Aug 17, 2018	Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Torrent Pharma Inc.
Aug 17, 2018	Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 m...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Torrent Pharma Inc.
Aug 17, 2018	Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by:...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Torrent Pharma Inc.
Aug 17, 2018	Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Torrent Pharma Inc.
Aug 17, 2018	Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Torrent Pharma Inc.
Aug 17, 2018	Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 ...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Torrent Pharma Inc.
Aug 17, 2018	Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Torrent Pharma Inc.
Aug 17, 2018	Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, R...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Torrent Pharma Inc.
Aug 17, 2018	Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg...	CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.	Class II	Torrent Pharma 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.