Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Is Pilocarpine recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Pilocarpine (9 total). Check the affected lots below.
Most common reason: Stability / shelf life (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pilocarpine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Pilocarpine recalls on record
none so far in 2026; 9 on record, newest first
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine HCL Ophthalmic Solution
cGMP deviations: Temperature abuse
Class III · Low risk
Pilocarpine Hydrochloride Ophthalmic Solution 4%
Failed Impurities/Degradation Specifications.
Class III · Low risk
Isopto Carpine
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Pilocarpine
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
Pilocarpine
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Class II · Moderate risk
Pilocarpine HCL P.F in B.S.S Ophthalmic 1% Injectable 36 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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