Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

4076–4100 of 5062

ModerateFDA (Drugs)·D-0671-2022·2022-03-30
Clobetasol Propionate Cream USP 0.05% Recall for cGMP Deviations
Teligent Pharma is recalling all unexpired Clobetasol Propionate Cream USP 0.05% nationwide due to current Good Manufacturing Practice (cGMP) deviations related to discontinuation of the firm's stability study program.
Product
Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15; b) 30 grams tube, NDC 52565-094-30; c) 45 grams tube, NDC 52565-094-45; d) 60 grams tube, NDC 52565-094-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0674-2022·2022-03-30
Clobetasol Propionate Gel Recalled Due to Manufacturing Deviations
Teligent Pharma is recalling all unexpired batches of Clobetasol Propionate Gel 0.05% due to deviations from good manufacturing practices. The firm discontinued its stability study program, prompting the recall of 81,883 tubes distributed nationwide and in Puerto Rico.
Product
Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube, NDC 52565-082-30; c) 60 grams tube, NDC 52565-082-60, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0675-2022·2022-03-30
Desonide Ointment Recalled Due to cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Desonide Ointment 0.05% nationwide because the manufacturer is discontinuing its stability study program, a deviation from current good manufacturing practices (cGMP).
Product
Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 g tubes, NDC 52565-038-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0692-2022·2022-03-30
Hydrocortisone Butyrate Lotion Recalled Due to cGMP Deviations
Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% nationwide due to cGMP deviations. The firm discontinued its stability study program, prompting recall of all products within expiry.
Product
Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0686-2022·2022-03-30
Gentamicin Sulfate Cream USP 0.1% Recalled for cGMP Deviations
Teligent Pharma is recalling Gentamicin Sulfate Cream USP 0.1% distributed nationwide because the manufacturer is discontinuing its stability study program, which represents a deviation from FDA good manufacturing practices (cGMP).
Product
Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0677-2022·2022-03-30
Desoximetasone Ointment USP 0.05% Recall Due to cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Desoximetasone Ointment USP 0.05% (54,897 tubes) distributed nationwide because the manufacturer is discontinuing its stability study program, a violation of current good manufacturing practices.
Product
Desoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565-045-99; b) 60 grams tubes, NDC 52565-045-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0714-2022·2022-03-30
Diclofenac Sodium Topical Solution recalled due to leaking containers
Direct Rx is recalling Diclofenac Sodium Topical Solution 1.5% (150 mL) nationwide due to defective containers that may leak. Consumers who have purchased this product should stop use and contact their pharmacy or physician.
Product
Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-675-05
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0701-2022·2022-03-30
Diflorasone Diacetate Ointment USP 0.05% Nationwide Recall
Teligent Pharma is recalling all unexpired batches of Diflorasone Diacetate Ointment USP 0.05% nationwide due to cGMP deviations related to discontinuation of the stability study program.
Product
Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured by: Teligent Pharm, Inc., Buena, New Jersey 08310, NDC 52565-063-60.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0711-2022·2022-03-30
Phenylephrine HCl Injection Recalled for Defective Container
Athenex Pharma Solutions is recalling Phenylephrine HCl Injection (20 mg, 250 mL excel bags) distributed nationwide due to defective container issues. The recall affects three specific lots.
Product
Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-491-15
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0676-2022·2022-03-30
Desoximetasone Ointment USP 0.05% Recalled Due to cGMP Deviations
Teligent Pharma is recalling Desoximetasone Ointment USP 0.05% nationwide due to current good manufacturing practice (cGMP) deviations. The firm is discontinuing its stability study program, affecting all products within expiry.
Product
Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0678-2022·2022-03-30
Desoximetasone Ointment USP Recalled by Teligent Pharma
Teligent Pharma is recalling Desoximetasone Ointment USP 0.25% in all sizes nationwide due to cGMP deviations related to discontinuation of the stability study program.
Product
Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99; b) 60 grams tubes, NDC 52565-030-60; c) 15 grams tubes, NDC 52565-030-15, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0707-2022·2022-03-30
Norepinephrine Bitartrate Injection Recalled for Defective Container
Athenex Pharma Solutions recalls Norepinephrine Bitartrate Injection due to defective container issues. The recall affects 5,320 bags distributed nationwide.
Product
Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chloride, 16 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-476-15
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0720-2022·2022-03-30
Compounded injectable Formula F9 recalled for insufficient potency
Olympia Compounding Pharmacy recalled Formula F9, a compounded injectable medication, because the product was sub-potent with insufficient active ingredient. The recall affected 493 vials distributed nationwide.
Product
Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Each ML contains: 0.5% Chlorobutanol NF, 0.005% Edetate Disodium Dihydrate USP, 2.74% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 1% Ethyl Alco
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0690-2022·2022-03-30
Hydrocortisone Butyrate Lotion recalled due to cGMP deviations
Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% (4 fl. oz. bottles) nationwide because the manufacturer discontinued its stability study program, which is a deviation from good manufacturing practice standards.
Product
Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0695-2022·2022-03-30
Nystatin and Triamcinolone Acetonide Ointment Recall Due to cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Nystatin and Triamcinolone Acetonide Ointment (15g, 30g, and 60g tubes) nationwide due to current Good Manufacturing Practice (cGMP) deviations related to discontinuation of the stability study program.
Product
Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-15; b) 30 grams tubes, NDC 52565-042-30; c) 60 grams tubes, NDC 52565-042-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0682-2022·2022-03-30
Econazole Nitrate Cream Recalled Due to Manufacturing Process Deviations
Teligent Pharma is recalling Econazole Nitrate Cream, 1% due to current Good Manufacturing Practice deviations related to discontinued stability studies. Approximately 151,975 tubes distributed nationwide are affected.
Product
Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDC 52565-022-85; c) 30 grams tubes, NDC 52565-022-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0697-2022·2022-03-30
Triamcinolone Acetonide Cream USP 0.1% Recall — Stability Study Discontinuation
Teligent Pharma is recalling all unexpired Triamcinolone Acetonide Cream USP 0.1% nationwide due to discontinuation of its stability study program, which creates a cGMP deviation. The company has recalled approximately 721,225 tubes and 90,893 jars distributed across multiple package sizes.
Product
Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15; b) 30 grams tubes, NDC 52565-056-30; c) 80 grams tubes, NDC 52565-056-80, d) 1 lb (454 g) jars, NDC 52565-056-26; Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0704-2022·2022-03-30
Lidocaine Cream 4% Recalled Due to Manufacturing Quality Deviations
Teligent Pharma is recalling all unexpired batches of Lidocaine Cream 4% (30-gram tubes) nationwide because the company is discontinuing its stability study program, a violation of manufacturing standards.
Product
Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0536-1281-28.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0680-2022·2022-03-30
Diclofenac Sodium Topical Solution Recalled for Manufacturing Compliance Deviations
Teligent Pharma recalled 36,018 bottles of Diclofenac Sodium Topical Solution nationwide due to cGMP deviations related to discontinued stability studies, affecting all batches through May 2024.
Product
Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-025-05.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0712-2022·2022-03-30
Epinephrine Injection recalled due to defective container
Athenex Pharma Solutions is recalling Epinephrine Injection 8 mg per 250 mL (excel bag) nationwide due to a defective container. The affected lots are F2101780 and F2101781, expiring 6/21/22.
Product
Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-814-15
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0702-2022·2022-03-30
Gentamicin Sulfate Cream Recalled Due to Manufacturing Practice Violations
Teligent Pharma, Inc. is recalling 31,489 tubes of Gentamicin Sulfate Cream (0.1%) nationwide due to manufacturing violations. The company discontinued its stability testing program without proper authorization.
Product
Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured for: SOLA Pharmaceuticals, LLC, Baton Rouge, LA 70810, NDC 70512-036-30.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0698-2022·2022-03-30
Triamcinolone Acetonide Lotion Recalled for cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Triamcinolone Acetonide Lotion USP 0.025% due to current Good Manufacturing Practice (cGMP) deviations related to discontinuation of the stability study program.
Product
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-010-59.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0684-2022·2022-03-30
Fluocinonide Gel Recalled for Manufacturing Process Deviations
Teligent Pharma, Inc. is recalling all Fluocinonide Gel USP 0.05% nationwide within expiration date due to manufacturing deviations related to discontinued stability studies.
Product
Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0710-2022·2022-03-30
Phenylephrine HCl Injection 50 mg Recalled for Defective Container
Athenex Pharma Solutions is voluntarily recalling Phenylephrine HCl Injection 50 mg in 250 mL excel bags distributed nationwide due to a defective container issue. The recall affects approximately 1,800 bags across three lots.
Product
Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-494-15
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0691-2022·2022-03-30
Halobetasol Propionate Ointment recalled due to cGMP deviations
Teligent Pharma is recalling all unexpired Halobetasol Propionate Ointment 0.05% (21,323 tubes) due to current good manufacturing practice (cGMP) deviations. The firm is discontinuing its stability study program.
Product
Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-998-67.
Category
Drug
Distribution
Distributed nationwide

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4076–4100 of 5062