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.

2651–2675 of 3531

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-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-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 (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
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 (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-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-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 (Food)·F-0896-2022·2022-03-30
Flow Alkaline Spring Water Organic Lemon Ginger Recalled for Adverse Reactions
Flow Beverages Inc. is recalling Flow Alkaline Spring Water in organic lemon and ginger flavor due to four customer complaints of alleged adverse reactions. The affected product was distributed across multiple U.S. states.
Product
Flow Alkaline Spring Water - Organic lemon & ginger flavored water. 500 ml 12 units per case . Tetra Pak paper carton.
Category
Food
Distribution
11 states
ModerateFDA (Drugs)·D-0689-2022·2022-03-30
Halobetasol Propionate Ointment Recalled for cGMP Deviations
Teligent Pharma is recalling all unexpired Halobetasol Propionate Ointment 0.05% due to current Good Manufacturing Practice (cGMP) deviations. The firm has discontinued its stability study program.
Product
Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15; b) 50 g tubes, NDC 52565-073-51, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
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-0693-2022·2022-03-30
Lidocaine Cream 4% Recalled Due to cGMP Deviations
Teligent Pharma is recalling all unexpired Lidocaine Cream 4% due to manufacturing quality deviations. The firm has discontinued its stability study program.
Product
Lidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15; b) Net Wt. 30 grams tubes, NDC 52565-122-30; c) 5 x 5 gram tubes, NDC 52565-122-07; Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310; Manufactured by: Teligent Pharma, Inc., Buena, New Jer
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-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-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
0 states
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-0718-2022·2022-03-30
Sermorelin Acetate Injectable Recalled for Sub-Potent Strength
Olympia Compounding Pharmacy is recalling Sermorelin Acetate 9 mg multi-dose vials nationwide due to sub-potency. The affected lots do not contain the full intended strength of the medication.
Product
Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0059-00
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-0722-2022·2022-03-30
FDA recalls SB-4 compounded injection nationwide for below-strength potency
SB-4 compounded injection is being recalled nationwide because it contains less active ingredient than labeled. Olympia Compounding Pharmacy initiated this voluntary recall affecting 1,032 vials.
Product
SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023-05; b) 10 mL Multi-dose vial NDC 73198-0023-10, Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Man
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0802-2022·2022-03-23
Calcium Alginate Wound Dressings Recalled for Incorrect Instructions
CellEra LLC is recalling Vitale Silver calcium alginate wound dressings nationwide due to incorrect instructions for use containing language beyond FDA-cleared content.
Product
20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0805-2022·2022-03-23
Calcium Alginate Wound Dressings Recalled for Incorrect Instructions
CellEra LLC is recalling Vitale Silver calcium alginate dressings nationwide because packages contain incorrect Instructions for Use with language not approved by the FDA. The firm is providing replacement packages with corrected instructions.
Product
20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0787-2022·2022-03-23
Sorin Centrifugal Pump CP5 Drive Unit missing electromagnetic shielding component
LivaNova is recalling four Sorin Centrifugal Pump CP5 Drive Units because a ferrite ring on the power cable may be missing. The units were distributed in Florida, Texas, and Nebraska.
Product
Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.
Category
Medical Device
Distribution
3 states
ModerateFDA (Drugs)·D-0654-2022·2022-03-23
Alprazolam Tablets Recalled Due to Potential Cross-Contamination
Golden State Medical Supply Inc. is recalling Alprazolam Tablets, USP 1mg (180-count bottles, Lot #GS027852) due to potential cross-contamination with other drug substances during manufacturing.
Product
Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18.
Category
Drug
Distribution
0 states
ModerateFDA (Food)·F-0873-2022·2022-03-23
WAP Honey BBQ Seasoning Recalled Due to Undeclared Wheat Allergen
PS Seasoning & Spices, Inc. is recalling WAP Honey BBQ Seasoning because it contains undeclared wheat. Consumers with wheat allergies should not consume this product.
Product
WAP Honey BBQ Seasoning Net Wt 20.64 lbs. (9.36kg). Part #180002073. Ingredients: Raw Cane Sugar, Sea Salt, Dried Honey, Spices, Brown Sugar, Onion and Garlic Powder, Dried Molasses, Natural Flavors.
Category
Food
Distribution
27 states