Class II · Moderate risk
GLYCOpyrrolate
Lack of Assurance of Sterility
Is Glycopyrrolate recalled?
Yes — there is an active recall. 5 ongoing FDA recalls mention Glycopyrrolate (49 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Glycopyrrolate. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Glycopyrrolate recalls on record
none so far in 2026; 49 on record, newest first
Class II · Moderate risk
GLYCOpyrrolate
Lack of Assurance of Sterility
Class II · Moderate risk
Glycopyrrolate 0.6 mg/3 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Glycopyrrolate Injectable Solution 1 mg/5 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes…
Lack of sterility assurance.
Class II · Moderate risk
Glycopyrrolate in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Glycopyrrolate Injection Solution
Lack of Sterility Assurance.
Class II · Moderate risk
Glycopyrrolate Injection Solution
Lack of Sterility Assurance.
Class II · Moderate risk
Glycopyrrolate Injection Solution
Lack of Sterility Assurance.
Class II · Moderate risk
Glycopyrrolate all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Glycopyrrolate 1 mg/5 mL
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Glycopyrrolate USP
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Glycopyrrolate 0.2 mg/mL
Stability data does not support expiry.
Class II · Moderate risk
Glycopyrrolate
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
glycopyrrolate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
glycopyrrolate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
glycopyrrolate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
Glycopyrrolate 0.2 mg/1 mL Susp
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
Glycopyrrolate injection
Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" and "3" making the actual "Use By 3/2015" date appear to read "Use By8/2015".
Class II · Moderate risk
Glycopyrrolate 0.2 mg/ml
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class I · High risk
Glycopyrrolate
Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.
Class II · Moderate risk
Glycopyrrolate
Labeling: Label Mixup: GLYCOPYRROLATE, Tablet, 2 mg may have potentially been mislabeled as one of the following drugs: PARICALCITOL, Capsule, 1 mcg, NDC 00074431730, Pedigree: W002667, EXP: 6/5/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000850, Pedigree: W003244, EXP: 6/17/2014; LACTOBACILLUS, Tablet, 0, NDC 64980012950, Pedigree: AD22865_1, EXP: 5/2/2014.
Class II · Moderate risk
GLYCOPYRROLATE Tablet
Labeling: Label Mixup; GLYCOPYRROLATE Tablet, 2 mg may be potentially mislabeled as LACTOBACILLUS, Tablet, NDC 64980012950, Pedigree: W003624, EXP: 1/31/2014.
Class III · Low risk
Glycopyrrolate Tablets
Subpotent Drug
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