Graviti Pharmaceuticals Private Limited Bupropion Hydrochloride Extended-Release recall: Failed Tablet/Capsule Specifications
Failed Tablet/Capsule Specifications
The hazard: Drug safety concern
The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.
What the notice says: Failed Tablet/Capsule Specifications
Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.
Recall details
- Recall number
- D-0037-2026
- Published
- October 29, 2025
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Graviti Pharmaceuticals Private Limited
- Product type
- Prescription & OTC drugs
- Units affected
- 46,512/30 count bottles
- Distribution
- Nationwide
- Made in
- India
- Lot / code info
- Batch # BPB124341A, Exp date: 10/2026
Products covered by this recall
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.
Check your product
The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- BPB124341A
Best-by / use-by date
Printed beside the lot code, not on the price sticker.
- 10
- 2026 — 46
- 512
- 30 count bottles
NDC number
On the carton and again on the bottle or blister label.
- 16571-863-03
Package size
Match the net weight or the piece count on the front of the pack.
- 300 mg
- 30 count
Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Drug safety
Graviti Pharmaceuticals Private Limited — The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.
- Check the lot number on your pack against the codes listed above.
- Ask the dispensing pharmacy for a replacement from an unaffected lot.
- Keep the carton; the lot number is often printed only on the outer pack.
- Report side effects you think the product caused to FDA MedWatch.
What the company owes you
A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.
- The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
- Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
- Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
- Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.
Company contact: Graviti Pharmaceuticals Private Limited — E & 621 Patancheru Mandal, Hyderabad
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Graviti Pharmaceuticals Private Limited prescription & otc… recalled?
Failed Tablet/Capsule Specifications Failed Tablet/Capsule Specifications
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: lot code BPB124341A; best-by date 10 or 2026 — 46. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Check the lot number on your pack against the codes listed above.
Can I get my money back?
The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
Where was the recalled product sold?
It was distributed nationwide.
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