Class II · Moderate risk
Promethazine HCl Oral Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Is Promethazine recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Promethazine (18 total). Check the affected lots below.
Most common reason: Sterility / contamination (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Promethazine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Promethazine recalls on record
none so far in 2026; 18 on record, newest first
Class II · Moderate risk
Promethazine HCl & Codeine Phosphate Oral Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Promethazine HCl Tablets
cGMP deviations: Temperature abuse
Class II · Moderate risk
Promethazine HCl Topical Ointment
CGMP Deviations
Class II · Moderate risk
Promethazine With Codeine Oral Solution
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Promethazine Syrup Plain
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Promethazine Plain Oral Solution 6.25mg/5ml 473ml
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Promethazine Gel 50 mg/mL
Lack of Processing Controls.
Class II · Moderate risk
Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag
Lack of Assurance of Sterility
Class II · Moderate risk
Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag
Lack of Assurance of Sterility
Class II · Moderate risk
Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag
Lack of Assurance of Sterility
Class III · Low risk
Promethazine Vc With Codeine Syrup
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
Class II · Moderate risk
Promethazine Dm Syrup
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Class II · Moderate risk
Promethazine 25 mg/0.5 mLGel
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
PROMETHAZINE HYDROCHLORIDE Tablets
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Class II · Moderate risk
Promethazine HCL
Labeling:Label Mixup; PROMETHAZINE HCL, Tablet, 25 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002574, EXP: 6/3/2014.
Class III · Low risk
Prometh VC with Codeine Cough Syrup
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Class III · Low risk
Prometh VC Plain
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
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