Class II · Moderate risk
Cimetidine HCl Oral Solution 300mg/5mL
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Is Cimetidine recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Cimetidine (3 total). Check the affected lots below.
Most common reason: cGMP deviation (1 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cimetidine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Cimetidine recalls on record
none so far in 2026; 3 on record, newest first
Class II · Moderate risk
Cimetidine Hydrochloride Oral Solution 300 mg/5 mL
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Class II · Moderate risk
Cimetidine 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.
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