Class II · Moderate risk
Famotidine Injection in Sodium Chloride Injection
CGMP Deviations
Is Famotidine recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Famotidine (23 total). Check the affected lots below.
Most common reason: Sterility / contamination (5 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Famotidine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Famotidine recalls in 2026
1 initiated in 2026, 23 in total — newest first
Class I · High risk
Famotidine Injection
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class II · Moderate risk
Ibuprofen and Famotidine Tablets 800mg/26.6mg
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Class II · Moderate risk
Famotidine Tablets
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Class II · Moderate risk
Famotidine Tablets USP 40mg
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Class III · Low risk
Famotidine Injection
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Class III · Low risk
Famotidine tablets
Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.
Class II · Moderate risk
Famotidine USP 20 mg
Failed Tablet/Capsule Specification: out of specification for tablet weight.
Class II · Moderate risk
Famotidine Tablets USP
Failed Tablet/Capsule Specification; out of specification for tablet weight
Class III · Low risk
Famotidine for Oral Suspension USP
CGMP Deviations
Class II · Moderate risk
Famotidine HCl all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Famotidine injection syringe a) 10 mg/1 mL b) 80 mg/8 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Famotidine tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Tpn 3:1
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Famotidine Tablets
CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.
Class II · Moderate risk
Famotidine active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class III · Low risk
Famotidine for Oral Suspension
Failed Impurity/Degradation Specification; 12-month stability time point
Class II · Moderate risk
Famotidine Injection 20 mg
Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.
Class II · Moderate risk
FAMOTIDINE Tablet
Labeling: Label Mixup; FAMOTIDINE Tablet, 20 mg may be potentially mislabeled as CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, NDC 00007337113, Pedigree: W003225, EXP: 6/17/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003506, EXP: 6/21/2014; FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003507, EXP: 6/21/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 0037822500
Class III · Low risk
Famotidine Tablets USP
Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
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