Buprenorphine Hydrochloride recall
FDA recall D-0527-2026 · initiated Mar 13, 2026
ENDO USA, Inc. recalled Buprenorphine Hydrochloride in Mar 2026 — an FDA Class II recall (D-0527-2026) because Crystallization; identified as Buprenorphine free base.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Crystallization; identified as Buprenorphine free base
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
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: 34,293 vials
Details
- Product
- Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
- Recalling company
- Endo Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Mar 13, 2026
- FDA report date
- May 20, 2026
Frequently asked
- Was Buprenorphine Hydrochloride recalled?
- ENDO USA, Inc. recalled Buprenorphine Hydrochloride in Mar 2026 — an FDA Class II recall (D-0527-2026) because Crystallization; identified as Buprenorphine free base. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Buprenorphine Hydrochloride recalled?
- Per the FDA enforcement record, the reason for recall D-0527-2026 was: Crystallization; identified as Buprenorphine free base
- Is a recalled Buprenorphine Hydrochloride 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. May cause temporary or medically reversible harm; low probability of serious harm. 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 Buprenorphine Hydrochloride are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027. 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-0527-2026.