Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Recall 2026
BUPRENORPHINE HYDROCHLORIDEIssued September 8, 2026Updated Reviewed by the Recall Watch editorial team
BUPRENORPHINE HYDROCHLORIDE Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05 — recalled per FDA on 9/8/2026. Reason: Crystallization.
- Agency
- FDA
- Issued
- Sep 8, 2026
- Brand
- BUPRENORPHINE HYDROCHLORIDE
- Distribution
- 1 states
- Lots affected
- 7
Steps to take for this recall
Stop using it
Take it out of rotation. Don't consume, wear, or operate.
Verify the match
Compare lot numbers, UPCs, and dates against your product.
Return or dispose
Follow the manufacturer's instructions to refund or safely dispose.
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What's recalled
Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05
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Why it was recalled
Crystallization
Affected products & lot numbers7 lots called out
Affected Lot Numbers
Check your product label — do not use if your lot number appears below.
| Lot Number |
|---|
| Lot#:83912 |
| Exp Date 10/2026 Lot#:84234 |
| Exp Date 11/2026 Lot#:84990 |
| Exp Date 11/2026 Lot#:85003 |
| Exp Date 12/2026 Lot#:86443 |
| Exp Date 01/2027 Lot#:89909 |
| Exp Date 05/2027 |
Where was it sold1 state
U.S. Nationwide
More recalls like this4 related — by brand, contaminant, and category
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Frequently asked questions
Is the BUPRENORPHINE HYDROCHLORIDE recall still active?
Yes, this recall is currently active as of September 8, 2026. Do not use or consume the affected product.
What lot numbers are affected?
Affected lot numbers: Lot#:83912, Exp Date 10/2026 Lot#:84234, Exp Date 11/2026 Lot#:84990, Exp Date 11/2026 Lot#:85003, Exp Date 12/2026 Lot#:86443, Exp Date 01/2027 Lot#:89909, Exp Date 05/2027. Check the label on your product.
What should I do if I have the recalled BUPRENORPHINE HYDROCHLORIDE?
Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.