Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

4676–4700 of 21589

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-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-0708-2022·2022-03-30
Norepinephrine Bitartrate Injection Recalled for Defective Container
Athenex Pharma Solutions is recalling Norepinephrine Bitartrate Injection 8 mg per 250 mL due to a defective container. The recall affects approximately 9,800 bags distributed nationwide.
Product
Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-475-15
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0694-2022·2022-03-30
Lidocaine Ointment USP 5% Recalled Due to cGMP Deviations
Teligent Pharma, Inc. is recalling all unexpired batches of Lidocaine Ointment USP, 5% nationwide and in Puerto Rico because the manufacturer is discontinuing its stability study program, a violation of good manufacturing practices.
Product
Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 oz) tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-008-14.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0687-2022·2022-03-30
Gentamicin Sulfate Ointment Recalled Due to cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Gentamicin Sulfate Ointment USP 0.1% due to cGMP deviations related to discontinuation of the firm's stability study program.
Product
Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams tube, NDC 52565-090-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 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-0688-2022·2022-03-30
Halobetasol Propionate Ointment Recalled for cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Halobetasol Propionate Ointment 0.05% nationwide due to cGMP deviations. The manufacturer is discontinuing its stability study program.
Product
Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-033-50.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0703-2022·2022-03-30
Hydrocortisone Butyrate Lotion Recalled for cGMP Deviations
Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% due to current Good Manufacturing Practice (cGMP) deviations related to the firm's discontinuation of its stability study program.
Product
Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-032-04.
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-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-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-0679-2022·2022-03-30
Diclofenac Sodium Topical Solution recalled by Teligent Pharma
Teligent Pharma is recalling all unexpired batches of Diclofenac Sodium Topical Solution 1.5% due to current good manufacturing practice (cGMP) deviations related to discontinuation of the firm's stability study program.
Product
Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-002-05.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0709-2022·2022-03-30
Phenylephrine HCl Injection Recalled Due to Defective Container
Athenex Pharma Solutions is recalling one lot of Phenylephrine HCl Injection due to a defective container. The recall affects 670 bags distributed nationwide.
Product
Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-493-15
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0715-2022·2022-03-30
Rock Town Distillery Hand Sanitizer Recall Due to Chemical Contamination
Rock Town Distillery is recalling hand sanitizer products distributed in Arkansas due to FDA findings of acetal and acetaldehyde above specification limits resulting from manufacturing deviations.
Product
ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solution packaged in a) 375 mL (12.7 fl. oz.), NDC 74492-0002-1; b) 3785 mL/1 gallon NDC 74492-0002-2; c) 236 mL/8 oz. NDC 74492-0002-3; d) 473 mL/16 oz. NDC 74492-0002-4; Made in USA Rock Town Distillery,
Category
Drug
Distribution
1 state
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 (Devices)·Z-0822-2022·2022-03-30
Medical device products from Family Dollar stores recalled for rodent contamination risk
Medical device products from Family Dollar stores in six Southern states are being recalled due to potential rodent activity at a distribution center. Affected items include feminine hygiene products, surgical masks, contact lens solutions, and bandages.
Product
Medical Device products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee. The general categories of products, but are limited to these products, includes: feminine hygiene products, surgical masks, contact le
Category
Medical Device
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
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-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-0700-2022·2022-03-30
Clobetasol Propionate Cream USP Recalled for cGMP Deviations
Teligent Pharma, Inc. is recalling Clobetasol Propionate Cream USP 0.05% in 60-gram tubes due to current Good Manufacturing Practice (cGMP) deviations. The firm discontinued its stability study program, affecting all products within expiry nationwide and in Puerto Rico.
Product
Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton Rouge, LA 70809; NDC 70512-028-60.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0673-2022·2022-03-30
Clobetasol Propionate Ointment USP 0.05% Nationwide Recall
Teligent Pharma is recalling all unexpired batches of Clobetasol Propionate Ointment USP 0.05% nationwide because the manufacturer is discontinuing its stability study program, raising questions about product integrity.
Product
Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15; b) 30 grams tube, NDC 52565-039-30; c) 45 grams tube, NDC 52565-039-45; d) 60 grams tube, NDC 52565-039-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0672-2022·2022-03-30
Clobetasol Propionate Lotion recall due to manufacturing deviations
Teligent Pharma is recalling 35,180 bottles of Clobetasol Propionate Lotion 0.05% nationwide due to manufacturing deviations and discontinued stability testing. No illnesses reported.
Product
Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565-055-04, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
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-0685-2022·2022-03-30
Fluocinonide Topical Solution Recalled Due to Manufacturing Deviations
Teligent Pharma recalled Fluocinonide Topical Solution USP 0.05% nationwide because the manufacturer is discontinuing stability testing. Without ongoing verification, the company cannot ensure product safety.
Product
Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bottles, NDC 52565-025-59, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0824-2022·2022-03-30
Cytocell Microscope Slides Recall: Incorrect Expiry Date on Label
Cytocell Ltd. is recalling Cytocell 8 Square Template Slides because the outer label displays an incorrect expiration date of 2023-05 when the actual validated shelf life expires 2022-02.
Product
Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
Category
Medical Device
Distribution
Distributed nationwide