Major Pharmaceuticals recalls Gabapentin 100 mg capsules over impurity level found in stability testing
Routine stability testing found an unknown impurity in these gabapentin capsules above the allowed limit, so the capsules did not meet the required quality standards.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).; Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC…
- Company
- The Harvard Drug Group LLC
- Hazard
- Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
- Where sold
- US Nationwide.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- October 17, 2025
- Recall started
- October 10, 2025
- FDA enforcement report
- October 29, 2025
- Identifiers
- Codes: Lot # M04989A [Bag], M04989 [Blister Pack], Exp Date: 02/2026; Lot # M05056A [Bag], M05056 [Blister Pack], Exp Date: 04/2026; Lot # M05150A [Bag], M05150 [Blister Pack], Exp Date: 07/2026; Lot # M05312A [Bag], M05312 [Blister Pack], and M05342A [Bag], M05342 [Blister Pack], Exp Date: 01/2027.
- FDA recall number: D-0031-2026
- Codes: Lot # M04950, Exp Date: 01/2026; Lot # M04989, M04990, Exp Date: 02/2026; Lot # M05056, Exp Date: 04/2026; Lot # M05150, Exp Date: 07/2026; Lot # M05290, Exp Date: 11/2026; Lot # M05312, M05342, Exp Date: 01/2027; Lot # M05369, M05386, Exp Date: 02/2027.
- FDA recall number: D-0030-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag). | Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61
- Reason for recall
- Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
- Classification
- Class II (Ongoing)
- Distribution
- US Nationwide.
Related recalls
Harvard Drug Group recalls Memantine extended-release 7 mg capsules because they failed dissolution testing
The capsules failed dissolution specifications, which means they did not release the medicine into the body the way they are supposed to.
Harvard Drug Group recalls Omega-3-Acid Ethyl Esters 1 gram capsules because capsule shells failed testing
During routine stability testing, the capsule shells gave out-of-specification results for loss on drying, meaning the capsules did not meet the required quality standard.
The Harvard Drug Group LLC · 2,238 5 x 10 unit dose cartons
Major Pharmaceuticals recalls chlorpromazine tablets over impurity above the recommended limit
The tablets contain N-Nitroso Desmethyl Chlorpromazine, an impurity, at a level above the recommended intake limit, and the notice says the problem stems from manufacturing practice deviations.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · 6,086 units