Home / Recalls / The Harvard Drug Group LLC / D-0031-2026

D-0031-2026 Class II Ongoing

Recalled by The Harvard Drug Group LLC — Dublin, OH

Recall Details

Product Type
Drugs
Report Date
October 29, 2025
Initiation Date
October 10, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

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).

Reason for Recall

Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

Distribution Pattern

US Nationwide.

Code Information

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.

Other recalls by The Harvard Drug Group LLC

  • D-0383-2026 Class II — Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), R (February 17, 2026)
  • D-0030-2026 Class II — Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, (October 10, 2025)
  • D-0507-2025 Class II — Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx (June 19, 2025)
  • D-0508-2025 Class II — Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged (June 19, 2025)
  • D-0878-2023 Class II — Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, (June 16, 2023)
  • D-0570-2023 Class III — Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets p (April 24, 2023)
  • D-0432-2023 Class II — Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Onl (February 23, 2023)
  • D-0649-2022 Class II — PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 bli (February 28, 2022)
  • D-0653-2022 Class II — hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs (February 24, 2022)
  • D-0807-2021 Class II — Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, (August 6, 2021)