Gabapentin Capsules recall
FDA recall D-0311-2025 · initiated Mar 4, 2025
SUN PHARMACEUTICAL INDUSTRIES INC recalled Gabapentin Capsules in Mar 2025 — an FDA Class III recall (D-0311-2025) because Cross Contamination.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Cross Contamination
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 12,876 bottles
Details
- Product
- Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.
- Recalling company
- Sun Pharm Industries
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Mar 4, 2025
- FDA report date
- Apr 16, 2025
Frequently asked
- Was Gabapentin Capsules recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Gabapentin Capsules in Mar 2025 — an FDA Class III recall (D-0311-2025) because Cross Contamination. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Gabapentin Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0311-2025 was: Cross Contamination
- Is a recalled Gabapentin Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Gabapentin Capsules are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot # a) HAD1458A, Exp. date 04/2025, HAD2718A, Exp. date 07/2025, b) HAD3432A, exp. date 08/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0311-2025.