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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 21, 2022 The Natural Dentist Healthy Breath Antiseptic Rinse, Cool Mint, 16.9 FL OZ (5... Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Pep... Class II Revive Personal Products Company
Mar 21, 2022 Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Table... CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit. Class II Sandoz, Inc
Mar 18, 2022 NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate... Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability stud... Class III Advanced Accelerator Applications USA, Inc.
Mar 17, 2022 Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by:... Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which ... Class II Aurolife Pharma, LLC
Mar 16, 2022 Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Re... Failed Impurities/Degradation Specifications: Out of Specification results for related substance. Class III Dr. Reddy's Laboratories, Inc.
Mar 15, 2022 Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manu... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15;... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 5... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) ... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufa... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Telig... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles,... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 ... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC ... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, M... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Dist... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufac... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams t... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Desoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles,... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manuf... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufa... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only,... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams t... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, ... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Lidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15;... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manuf... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 525... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx only, Manuf... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, ND... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 oz) tube, Rx Only, Teligent... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 ... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufact... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 5... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 15, 2022 Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, T... cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... Class II Teligent Pharma, Inc.
Mar 11, 2022 Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit... Labeling: Label Mix-Up Class II DASH Pharmaceuticals LLC
Mar 10, 2022 Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured... FAILED CONTENT UNIFORMITY SPECIFICATIONS Class III Macleods Pharma Usa Inc
Feb 17, 2022 Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual p... Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride pow... Class III Dr. Reddy's Laboratories, Inc.
Feb 16, 2022 Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: M... cGmp Deviations Class II Macleods Pharma Usa Inc
Feb 15, 2022 Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, ... cGMP deviations Class II Macleods Pharma Usa Inc
Feb 8, 2022 THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters ... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingr... Class I Your Favorite Shop
Feb 7, 2022 70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 M... Labeling - product contains undeclared ethyl alcohol Class II Tsm Brands LLC
Feb 7, 2022 Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by:... Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Relat... Class II Teligent 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.