Class II · Moderate risk
buPROPion Hydrochloride Extended-release Tablets USP
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Bupropion Hydrochloride Extended-Release Tablets USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Tablet/Capsule Specifications
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
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.
Affected NDC
16571-0863-03
Compare with the code on your package — it is the most precise check available.
Drug: Bupropion Category: Mental Health Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| bupropion hydrochloride NDC 16571-0863 |
300 mg/1 | Tablet, Extended Release Oral |
Rising Pharma Holdings, Inc. | Rx |
- Recalling firm
- Graviti Pharmaceuticals Private Limited
- NDC code
- 16571-863-03
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0037-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Bupropion recalls
See all
Class II · Moderate risk
buPROPion Hydrochloride Extended-Release Tablets
Presence of Foreign Tablets/Capsules
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications
Class III · Low risk
Bupropion Hydrochloride Extended-Release Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
BuPROPion Hydrochloride Tablets
Failed Impurities/Degradation Specifications
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