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.

19001–19025 of 21751

ModerateFDA (Drugs)·D-763-2014·2014-01-29
Novartis Recalls Theraflu Cold and Flu Powder Packets Due to Foreign Substances
Novartis Consumer Health is recalling specific lots of Theraflu Cold and Flu powder packets because they may contain foreign substances. The recall affects products distributed in the U.S., Mexico, Russia, Korea, Panama, China, and Canada.
Product
Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg) powder packets, Forest Berries flavor, 10-count packets per box, UPC 4 607045 191760. (Russian product and Former Soviet Union product)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-794-2014·2014-01-29
FDA Recalls Calcium Acetate Capsules Due to Potential Labeling Errors
Aidapak Services, LLC is recalling Calcium Acetate capsules because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.
Product
CALCIUM ACETATE, Capsule, 667 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00054008826.
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-809-2014·2014-01-29
Aidapak Recalls Paricalcitol Capsules Due to Potential Labeling Errors
Aidapak Services is recalling Paricalcitol capsules because they may have been mislabeled as Ascorbic Acid or Cholecalciferol.
Product
PARICALCITOL, Capsule, 1 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074431730.
Category
Drug
Distribution
4 states
ModerateFDA (Devices)·Z-0783-2014·2014-01-29
Zimmer Segmental Systems Polyethylene Inserts Recalled for Loading Instructions
Zimmer, Inc. is recalling Segmental Systems Polyethylene Inserts to update surgical instructions regarding excessive loading risks.
Product
Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1027-2014·2014-01-29
Aidapak Recalls Niacin Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling Niacin 100 mg tablets that may be mislabeled as GuaiFENesin ER 600 mg. The recall covers repacked drugs distributed in four western states.
Product
NIACIN, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904227160.
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-804-2014·2014-01-29
Sildenafil Citrate Tablets Recalled for Potential Labeling Error
Aidapak Services, LLC is recalling Sildenafil Citrate 25 mg tablets that may have been mislabeled as a different medication.
Product
SILDENAFIL CITRATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00069420030.
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-996-2014·2014-01-29
Aidapak Recalls Cholecalciferol Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling 5,000-unit Cholecalciferol tablets because they may have been mislabeled as other medications. The repacked drugs were distributed in four western states.
Product
CHOLECALCIFEROL, Tablet, 5000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00761017840.
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-969-2014·2014-01-29
Aidapak Recalls Clindamycin Capsules Due to Potential Label Mixup
Aidapak Services, LLC is recalling Clindamycin HCL capsules because they may have been mislabeled as Melatonin tablets. The repacked drugs were distributed in four western states.
Product
CLINDAMYCIN HCL, Capsule, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591312001.
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-776-2014·2014-01-29
Montelukast Sodium Chew Tablets Recalled for Potential Labeling Error
Aidapak Services is recalling Montelukast Sodium chew tablets that may be mislabeled as Dicyclomine HCL. The error could lead to patients taking the wrong medication.
Product
MONTELUKAST SODIUM, CHEW Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006071131.
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-934-2014·2014-01-29
Aidapak Recalls Docusate Calcium Capsules Due to Labeling Errors
Aidapak Services, LLC is recalling 1,109 docusate calcium capsules because they may have been mislabeled as other medications. The affected products were distributed in four western states.
Product
DOCUSATE CALCIUM, Capsule, 240 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536375501.
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-766-2014·2014-01-29
Aidapak Recalls Duloxetine Capsules Due to Potential Labeling Errors
Aidapak Services, LLC is recalling Duloxetine HCl DR capsules because they may be mislabeled with other medications. The repacked drugs were distributed in four western states.
Product
DULoxetine HCl DR, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323560.
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-908-2014·2014-01-29
Aidapak Recalls Verapamil HCL ER Capsules Due to Labeling Error
Aidapak Services, LLC is recalling Verapamil HCL ER capsules because they may have been mislabeled as Febuxostat tablets.
Product
VERAPAMIL HCL ER, Capsule, 240 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378644001.
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-911-2014·2014-01-29
Saccharomyces Boulardii Capsules Recalled for Potential Label Mixup
Aidapak Services is recalling Saccharomyces Boulardii capsules because they may have been mislabeled as other prescription drugs.
Product
SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00414200007.
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-946-2014·2014-01-29
Lactobacillus Acidophilus Tablets Recalled for Potential Labeling Error
Aidapak Services, LLC is recalling Lactobacillus Acidophilus tablets because they may have been mislabeled as Repaglinide.
Product
LACTOBACILLUS ACIDOPHILUS, Tablet, 35 MILLION, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536718101.
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-816-2014·2014-01-29
Valsartan Tablets Recalled for Potential Labeling Mixup with Other Drugs
Aidapak Services is recalling Valsartan 160 mg tablets because they may have been mislabeled as other medications. The repacked drugs were distributed in four western states.
Product
VALSARTAN, Tablet, 160 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078035934.
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-862-2014·2014-01-29
Aidapak Recalls Nicotine Polacrilex Lozenges Due to Potential Labeling Errors
Aidapak Services is recalling 2 mg nicotine polacrilex lozenges because they may have been mislabeled as other prescription drugs. The affected products were distributed in four western states.
Product
NICOTINE POLACRILEX, LOZENGE, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00135051001.
Category
Drug
Distribution
4 states
ModerateFDA (Devices)·Z-0822-2014·2014-01-29
Puritan Bennett Ventilator Manual Labeling Correction for Oxygen Sensor Life
Nellcor Puritan Bennett is correcting operator and service manuals for PB700 and PB840 ventilators to clarify the operational life of the oxygen sensor.
Product
Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-752-2014·2014-01-29
Theraflu Cold Powder Recalled for Potential Foreign Substances
Novartis Consumer Health is recalling Theraflu Multi-Symptom Severe Cold powder packets because they may contain foreign substances.
Product
THERAFLU — THERAFLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-775-2014·2014-01-29
Aidapak Recalls Raltegravir Tablets Due to Potential Labeling Errors
Aidapak Services, LLC is recalling Raltegravir 400 mg tablets because they may be mislabeled as other medications. The recall covers specific lots distributed in four western states.
Product
RALTEGRAVIR, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006022761.
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-808-2014·2014-01-29
Aidapak Recalls Niacin ER Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling Niacin ER 500 mg tablets because they may have been mislabeled as other prescription drugs.
Product
NIACIN ER, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074307490.
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-774-2014·2014-01-29
SitaGLIPtin Tablets Recalled for Potential Labeling Mixup
Aidapak Services is recalling sitaGLIPtin phosphate tablets because they may be mislabeled as Lactobacillus or Cyanocobalamin.
Product
sitaGLIPtin PHOSPHATE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006011231.
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-971-2014·2014-01-29
Aidapak Recalls Pioglitazone Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling 15 mg Pioglitazone tablets because they may have been mislabeled as other medications. The repacked drugs were distributed in four western states.
Product
PIOGLITAZONE, Tablet, 15 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591320530.
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-917-2014·2014-01-29
Aidapak Recalls Potassium Acid Phosphate Tablets Due to Labeling Error
Aidapak Services, LLC is recalling Potassium Acid Phosphate 500 mg tablets because they may have been mislabeled as Prednisone 20 mg.
Product
POTASSIUM ACID PHOSPHATE, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00486111101.
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-767-2014·2014-01-29
Aidapak Recalls Atomoxetine Capsules Due to Potential Lovastatin Label Mixup
Aidapak Services is recalling Atomoxetine HCL capsules because they may be mislabeled as Lovastatin tablets. The repacked drugs were distributed in four western states.
Product
ATOMOXETINE HCL, Capsule, 18 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323830.
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-877-2014·2014-01-29
Midodrine HCL Tablets Recalled for Potential Labeling Error
Aidapak Services, LLC is recalling Midodrine HCL 2.5 mg tablets that may have been mislabeled as Pioglitazone HCL 15 mg.
Product
MIDODRINE HCL, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00185004001.
Category
Drug
Distribution
4 states