Class III · Low risk
AERO Tab PAIN RELIEVER
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Pain Relief & OTC Medication Recalls
Recalls of common over-the-counter and prescription pain relievers.
415 recalls in this category, newest first.
Class III · Low risk
ZEE+ painaid ESF Extra-Strength Formula
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk
Vica-Cet BACK PAIN RELIEF
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk
PainAway II
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class II · Moderate risk
Naproxen Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Naproxen Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Naproxen Sodum Tablets USP 220 mg
CGMP Deviations
Class III · Low risk
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer
Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
Class II · Moderate risk
Acetaminophen 325 mg tablets
cGMP deviations: Discolored acetaminophen
Class II · Moderate risk
Tramadol Hydrochloride Tablets USP 100mg
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Meloxicam Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Ibuprofen Oral Suspension USP 100mg/5ml 120ml
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Gabapentin Oral Solution
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Class I · High risk
Acetaminophen
Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.
Class II · Moderate risk
Acetaminophen Injection 1
Discoloration and failed pH specifications
Class III · Low risk
Benzhydrocodone and Acetaminophen Tablets
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
Class III · Low risk
Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100…
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Class III · Low risk
Extra Strength Headache Relief
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Class III · Low risk
Pain Relief Maximum Strength
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Class III · Low risk
Gabapentin Tablets USP
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Class II · Moderate risk
Acetaminophen and Codeine Phosphate 300/30 mg tablet
cGMP Deviations
Class II · Moderate risk
Oxycodone and Acetaminophen Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk
Gabapentin Capsules
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
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