FDA DrugsClass II
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle...
Published: June 17, 2026Recall ID: D-0597-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Product Description & Identification
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30
Affected Products
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30
Additional Source Details
| Field | Value |
|---|---|
| City | Bedminster |
| State | NJ |
| Openfda › Unii | 0020414E5U |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 629695 |
| Openfda › Rxcui › 2 | 629697 |
| Openfda › Rxcui › 3 | 629699 |
| Openfda › Rxcui › 4 | 858062 |
| Openfda › Rxcui › 5 | 858372 |
| Openfda › Rxcui › 6 | 1013659 |
| Openfda › Rxcui › 7 | 1013662 |
| Openfda › Rxcui › 8 | 1013665 |
| Openfda › Spl id | 51213aa1-873c-4b55-a36d-3ebbb73fa220 |
| Openfda › Brand name | MINOCYCLINE HYDROCHLORIDE |
| Openfda › Spl set id | a8f95207-b259-4f50-87f2-3652d9268890 |
| Openfda › Package ndc › 1 | 67877-578-14 |
| Openfda › Package ndc › 2 | 67877-578-30 |
| Openfda › Package ndc › 3 | 67877-578-01 |
| Openfda › Package ndc › 4 | 67877-578-05 |
| Openfda › Package ndc › 5 | 67877-576-14 |
| Openfda › Package ndc › 6 | 67877-576-30 |
| Openfda › Package ndc › 7 | 67877-576-01 |
| Openfda › Package ndc › 8 | 67877-576-05 |
| Openfda › Package ndc › 9 | 67877-577-14 |
| Openfda › Package ndc › 10 | 67877-577-30 |
| Openfda › Package ndc › 11 | 67877-577-01 |
| Openfda › Package ndc › 12 | 67877-577-05 |
| Openfda › Package ndc › 13 | 67877-643-14 |
| Openfda › Package ndc › 14 | 67877-643-30 |
| Openfda › Package ndc › 15 | 67877-643-01 |
| Openfda › Package ndc › 16 | 67877-643-05 |
| Openfda › Package ndc › 17 | 67877-644-14 |
| Openfda › Package ndc › 18 | 67877-644-30 |
| Openfda › Package ndc › 19 | 67877-644-01 |
| Openfda › Package ndc › 20 | 67877-644-05 |
| Openfda › Package ndc › 21 | 67877-436-14 |
| Openfda › Package ndc › 22 | 67877-436-30 |
| Openfda › Package ndc › 23 | 67877-436-01 |
| Openfda › Package ndc › 24 | 67877-436-05 |
| Openfda › Package ndc › 25 | 67877-437-14 |
| Openfda › Package ndc › 26 | 67877-437-30 |
| Openfda › Package ndc › 27 | 67877-437-01 |
| Openfda › Package ndc › 28 | 67877-437-05 |
| Openfda › Package ndc › 29 | 67877-438-14 |
| Openfda › Package ndc › 30 | 67877-438-30 |
| Openfda › Package ndc › 31 | 67877-438-01 |
| Openfda › Package ndc › 32 | 67877-438-05 |
| Openfda › Product ndc › 1 | 67877-436 |
| Openfda › Product ndc › 2 | 67877-578 |
| Openfda › Product ndc › 3 | 67877-576 |
| Openfda › Product ndc › 4 | 67877-577 |
| Openfda › Product ndc › 5 | 67877-643 |
| Openfda › Product ndc › 6 | 67877-644 |
| Openfda › Product ndc › 7 | 67877-437 |
| Openfda › Product ndc › 8 | 67877-438 |
| Openfda › Generic name | MINOCYCLINE HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | MINOCYCLINE HYDROCHLORIDE |
| Openfda › Manufacturer name | Ascend Laboratories, LLC |
| Openfda › Application number | ANDA204453 |
| Openfda › Is original packager | true |
| Event id | 99129 |
| Address 1 | 135 Us Highway 202 206 Ste 15 |
| Address 2 | N/A |
| Code info | Lot# 25141635, Exp 4/30/2028 |
| Postal code | 07921-2608 |
| Report date | 20260617 |
| Product type | Drugs |
| Product quantity | 360 30-count bottles |
| Reason for recall | Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260601 |
| Initial firm notification | Letter |
| Center classification date | 20260617 |
Overview
- Recalling FirmAscend Laboratories, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA