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.

4701–4725 of 21589

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-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 (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-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-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 (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-0696-2022·2022-03-30
Triamcinolone Acetonide Ointment USP 0.5% Recalled by Teligent Pharma
Teligent Pharma is recalling Triamcinolone Acetonide Ointment USP 0.5% due to current good manufacturing practice (cGMP) deviations. The firm has discontinued its stability study program, affecting approximately 159,994 tubes distributed nationwide.
Product
Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-048-15.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0825-2022·2022-03-30
DigniCap Delta Scalp Cooling System instructions updated for headband use
Dignitana updated instructions for the DigniCap Delta Scalp Cooling System to recommend headband use and warn about condensation risk in certain environmental conditions.
Product
DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20190325-06-EN), DigniCap Delta Scalp Cooling Wrap (LAB 20190221-05-EN), DigniCap Delta Small Cooling Wrap (LAB 20200616-01-EN,
Category
Medical Device
Distribution
12 states
ModerateFDA (Food)·F-0904-2022·2022-03-30
Bison Shepherd's Pie recalled for incomplete fish allergen labeling
HumbleHungryHappy LLC recalls Bison Shepherd's Pie (10.5 oz and 15 oz) distributed in Oregon and online due to incomplete fish allergen declaration. The label declares 'Fish' but does not specify the fish type.
Product
Bison Shepherd's Pie, packaged meal, net wt. 10.5oz and 15 oz. Product is fully cooked, refrigerated, and to-be-reheated by consumers for immediate consumption. Product is packaged in a rectangular flexible plastic clamshell covered with plastic film lid. Product label is rea
Category
Food
Distribution
1 state
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-0721-2022·2022-03-30
Olympia Compounding Pharmacy recalls T-105 drug injection for potency issue
Olympia Compounding Pharmacy is recalling T-105, a compounded injectable drug containing papaverine, phentolamine, and PGE, due to a potency issue. The recall affects 1,093 vials distributed nationwide including Puerto Rico.
Product
T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) 5 mL Multi-dose NDC 73198-0005-05; b) 10 mL Multi-dose NDC 73198-0005-10; Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sod
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-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-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-0670-2022·2022-03-30
Clobetasol Propionate Cream Recalled Due to cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Clobetasol Propionate Cream USP 0.05% nationwide because the manufacturer is discontinuing its stability study program and cannot ensure compliance with current Good Manufacturing Practice standards.
Product
Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-30; c) 45 grams tube, NDC 52565-051-45; d) 60 grams tube, NDC 52565-051-60; Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0705-2022·2022-03-30
Lidocaine Ointment USP 5% Recalled Due to cGMP Deviations
Teligent Pharma, Inc. is recalling Lidocaine Ointment USP 5% nationwide because the manufacturer is discontinuing its stability study program, which constitutes a deviation from current good manufacturing practice (cGMP). All products within their expiration dates are affected.
Product
Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufactured for: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-341-35.
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-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 (Devices)·Z-0814-2022·2022-03-30
TCL1 Breakapart Probe May Display Unexpected Genetic Signals
Cytocell Ltd. is recalling TCL1 Breakapart FISH probes (Lot 074612) because the diagnostic test may show unexpected signals beyond the intended chromosome target.
Product
TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
Category
Medical Device
Distribution
1 state
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-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-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-0699-2022·2022-03-30
Triamcinolone Acetonide Ointment Recalled Due to cGMP Deviations
Teligent Pharma is recalling Triamcinolone Acetonide Ointment USP 0.1% nationwide because the manufacturer is discontinuing its stability study program, creating a current Good Manufacturing Practice (cGMP) deviation.
Product
Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-014-15; b) 80 grams tubes, NDC 52565-014-80; c) 1 lb (454 g) jars, NDC 52565-014-26; Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0876-2022·2022-03-23
Port City Soups Tex-Mex Chili Recalled for Unapproved Acidified Food Process
Tony's Tejas Salsa is recalling Port City Soups Tex-Mex Chili because the production process was not approved for acidified foods. The recall affects 81 units distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
Port City Soups Tex-Mex Chili 32oz glass mason jar sold by individual unit
Category
Food
Distribution
4 states
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