Class III · Low risk
Methadone Hydrochloride Tablets
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Is Methadone recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Methadone (11 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 Methadone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Methadone recalls on record
none so far in 2026; 11 on record, newest first
Class II · Moderate risk
Methadone
Lack of sterility assurance
Class II · Moderate risk
Methadone HCl Injection in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Methadone HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Methadone Hydrochloride Oral Concentrate
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Methadone Hydrochloride Oral Concentrate
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Methadone Hydrochloride Oral Concentrate
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
methadone HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
methadone HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
methadone HCl
Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
Methadone 10 mg/mL Injection
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
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