Class II · Moderate risk
Amoxicillin and Clavulanate Potassium for Oral Suspension USP
Subpotent drug; Clavulanate Potassium component
Is Amoxicillin recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Amoxicillin (20 total). Check the affected lots below.
Most common reason: Wrong potency / content (6 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Amoxicillin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Amoxicillin recalls on record
none so far in 2026; 20 on record, newest first
Class II · Moderate risk
Amoxicillin and Clavulanate Potassium Tablets USP
Subpotent Drug
Class II · Moderate risk
Amoxicillin Capsules
cGMP deviations: Temperature abuse
Class II · Moderate risk
AMOXICILLIN Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
AMOXICILLIN for Oral Suspension USP
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Amoxicillin 500mg 100
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Amoxicillin and Clavulanate Potassium Tablets
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Subpotent Product: assay results for Amoxicillin were below the specification limits.
Class II · Moderate risk
Amoxicillin and Clavulanate Potassium for Oral Suspension
Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
Class III · Low risk
Amoxicillin and Clavulanate Potassium Tablets
Subpotent Drug; Clavulanic Acid
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Subpotency: due to a low, out of specification test result for assay during stability testing.
Class III · Low risk
Amoxicillin for Oral suspension
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Class III · Low risk
Amoxicillin For Oral Suspension
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Superpotent drug: Out of specification test result for assay during stability testing.
Class II · Moderate risk
Amoxicillin Trihydrate active pharmaceutical ingredient packaged…
Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed between 01/05/12 through 02/12/15 are being recalled because they were repackaged without data to support the printed expiry date.
Class II · Moderate risk
triple therapy
Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
Class III · Low risk
Amoxicillin for Oral Suspension
Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.
Class III · Low risk
Amoxicillin for Oral Suspension
Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.
Class II · Moderate risk
Amoxicillin Capsules USP 500 mg
Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.
Class II · Moderate risk
Amoxicillin for Oral Suspension
Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point.
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