Class II · Moderate risk
Gabapentin Capsules
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Is Gabapentin recalled?
Yes — there is an active recall. 7 ongoing FDA recalls mention Gabapentin (25 total). Check the affected lots below.
Most common reason: Impurity / degradation (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Gabapentin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Gabapentin recalls on record
none so far in 2026; 25 on record, newest first
Class II · Moderate risk
Gabapentin Capsules
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Class II · Moderate risk
Gabapentin Capsules
Defective container; blister packaging inadequately sealed.
Class II · Moderate risk
Gabapentin Capsules
Defective container; blister packaging inadequately sealed.
Class II · Moderate risk
Gabapentin Tablets 600mg
CGMP Deviations
Class III · Low risk
Gabapentin Capsules
Cross Contamination
Class III · Low risk
Gabapentin Capsules
Cross Contamination
Class II · Moderate risk
Gabapentin Tablets
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Class III · Low risk
Gabapentin Tablets
Product mixup: one foreign tablet found in product.
Class III · Low risk
Gabapentin Tablets
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Class II · Moderate risk
Gabapentin Oral Solution
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Class III · Low risk
Gabapentin Tablets USP
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Class II · Moderate risk
Gabapentin Capsules
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk
Gabapentin Capsules
Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
Class II · Moderate risk
S-Calm Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Gabapentin USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class III · Low risk
Gabapentin Oral Solution
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Class II · Moderate risk
Gabapentin Tablets
Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg
Class II · Moderate risk
Gabapentin Capsules
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Class II · Moderate risk
Gabapentin Capsules
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Class II · Moderate risk
Gabapentin Capsules
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Class II · Moderate risk
Gabapentin active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Gabapentin Capsules
Failed Tablet/Capsule Specifications: Complaints of empty capsules received.
Class II · Moderate risk
Gabapentin
Labeling: Label Mixup: GABAPENTIN, Tablet, 600 mg may have potentially been mislabeled as the following drug: ARIPiprazole, Tablet, 15 mg, NDC 59148000913, Pedigree: AD21965_1, EXP: 5/1/2014.
Class III · Low risk
Glenmark Gabapentin Tablets
Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.
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