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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DateProductReasonClassFirm
Mar 31, 2021 Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 ... Microbial Contamination of Non-Sterile Product Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 31, 2021 IMPERIAL GOLD 2000, Male Sexual Performance Enhancement, 1 Capsule, UPC 71812... Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/o... Class II QMart
Mar 30, 2021 Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in ... Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sil... Class I Ummzy, LLC
Mar 30, 2021 PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 ... Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/o... Class II Na Na Collection
Mar 30, 2021 Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, M... Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sil... Class I Ummzy, LLC
Mar 30, 2021 Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count ... Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sil... Class I Ummzy, LLC
Mar 30, 2021 Triple SupremeZen Gold 3500, Packaged in paper packaging with a pill blister,... Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/o... Class II Na Na Collection
Mar 29, 2021 69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and ... Class I Nuri Trading LLC
Mar 29, 2021 Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-... Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil, an ... Class I Nuri Trading LLC
Mar 29, 2021 Thumbs Up 7 White 11K capsule, packaged in a) 1-count blister card and b) 10-... Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil sild... Class I Nuri Trading LLC
Mar 29, 2021 Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent... Failed Stability Specifications: product did not meet viscosity results. Class III Teligent Pharma, Inc.
Mar 29, 2021 Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count bo... Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and ... Class I Nuri Trading LLC
Mar 25, 2021 PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distr... Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and s... Class II Namoo Enterprise LLC
Mar 25, 2021 Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards, distributed S... Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and s... Class II S & B Story LLC
Mar 25, 2021 Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-... CGMP Deviaitons Class II Cosette Pharmaceuticals, Inc.
Mar 25, 2021 Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottl... Failed Moisture Limits: Out of specification for water content Class III SUN PHARMACEUTICAL INDUSTRIES INC
Mar 24, 2021 Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UP... Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and ... Class II Bit & Bet LLC
Mar 22, 2021 TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Pre... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class I Novo Nordisk Inc
Mar 22, 2021 NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dos... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class I Novo Nordisk Inc
Mar 22, 2021 TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Pre... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class I Novo Nordisk Inc
Mar 22, 2021 Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefill... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class I Novo Nordisk Inc
Mar 22, 2021 Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose ... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class I Novo Nordisk Inc
Mar 22, 2021 Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Pre... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class I Novo Nordisk Inc
Mar 22, 2021 Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL a... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class I Novo Nordisk Inc
Mar 22, 2021 Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class I Novo Nordisk Inc
Mar 22, 2021 Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufact... Failed Impurities/Degradation Specifications Class III Macleods Pharma Usa Inc
Mar 22, 2021 TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-do... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class I Novo Nordisk Inc
Mar 22, 2021 ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pe... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class II Novo Nordisk Inc
Mar 22, 2021 OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pe... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class II Novo Nordisk Inc
Mar 22, 2021 NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insu... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class I Novo Nordisk Inc
Mar 22, 2021 Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class II Novo Nordisk Inc
Mar 15, 2021 Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx on... Failed Impurities/Degradation Specifications Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 11, 2021 ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACT... Defective Delivery System: customer complaints concerning the injector pen breaking apart and dis... Class II Ferring Pharmaceuticals Inc
Mar 11, 2021 ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMAC... Defective Delivery System: customer complaints concerning the injector pen breaking apart and dis... Class II Ferring Pharmaceuticals Inc
Mar 4, 2021 Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Phar... Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities... Class III Teva Pharmaceuticals USA
Mar 2, 2021 Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vial... Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP Class III Ferring Pharmaceuticals Inc
Feb 26, 2021 Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each contain... Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low) Class II Alvogen, Inc
Feb 26, 2021 Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Di... Failed Dissolution Specifications: Out-of-specification results observed for dissolution during s... Class II Dr. Reddy's Laboratories, Inc.
Feb 22, 2021 Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouche... Subpotent Class III SUN PHARMACEUTICAL INDUSTRIES INC
Feb 19, 2021 Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 5511... Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and... Class III Dr. Reddy's Laboratories, Inc.
Feb 18, 2021 Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For In... Crystallization: customer complaints for crystallization in finished product. Class I Zydus Pharmaceuticals (USA) Inc
Feb 18, 2021 Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For I... Crystallization: customer complaints for crystallization in finished product. Class I Zydus Pharmaceuticals (USA) Inc
Feb 17, 2021 Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-3... Failed Dissolution Specifications Class II Dr. Reddy's Laboratories, Inc.
Feb 15, 2021 Adam's Secret Extra Strength 1500, 800 mg, 10 count blister packs, Distribute... Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and ... Class I Adams.Secret.co
Feb 15, 2021 Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials,... Chemical contamination; Unknown brown residue adhering to the inside of one vial. Class II Teva Pharmaceuticals USA
Feb 15, 2021 Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distribute... Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and ... Class I Adams.Secret.co
Feb 10, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), ... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Te... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL)... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA

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.