Class II · Moderate risk
Esomeprazole Magnesium Delayed-Release Capsules
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Is Magnesium recalled?
Yes — there is an active recall. 21 ongoing FDA recalls mention Magnesium (165 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Magnesium. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Magnesium recalls on record
none so far in 2026; 165 on record, newest first
Class II · Moderate risk
Magnesium Hydroxide 1200mg
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk
Milk of Magnesia USP
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class I · High risk
Magnesium Hydroxide 1200mg
Microbial Contamination of Non-Sterile Products
Class I · High risk
Milk of Magnesia USP
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Coated Back Relief Tablet
CGMP Deviations
Class II · Moderate risk
Back Relief II
CGMP Deviations
Class II · Moderate risk
ELECTROLYTE Supplement Tablets
cGMP deviations
Class II · Moderate risk
PAINAID BRF Back Relief Formula
cGMP deviations
Class II · Moderate risk
Backache & Muscle Relief
cGMP deviations
Class II · Moderate risk
Back Pain-Off
cGMP deviations
Class II · Moderate risk
Omeprazole Delayed-Release Capsules
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Class II · Moderate risk
Magnesium Chloride
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk
DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
Class II · Moderate risk
Prilosec (Omeprazole Magnesium)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class III · Low risk
Esomeprazole Magnesium Delayed Release Capsules USP
Discoloration: product contains brown pellets
Class III · Low risk
Magnesium Chloride Injection
Lack of Assurance of Sterility
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