CLASS II ONGOING Drug recall · Reported 17 Jun 2026 · FDA Enforcement Report
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg recalled
Ascend Laboratories is recalling Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, distributed nationwide in the US. The recall was initiated on 1 Jun 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0597-2026
- FDA event ID
- 99129
- Recalling firm
- Ascend Laboratories, Bedminster, NJ
- Manufacturer
- Ascend Laboratories, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Jun 2026
- FDA classified
- 17 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 1 Jun 2026 | Recall initiated by company | |
| 17 Jun 2026 | Classified by FDA | +16 days |
| 17 Jun 2026 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Which lots are affected?
Lot# 25141635, Exp 4/30/2028
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ascend Laboratories
All 50| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Dabigatran Etexilate Capsules, 150 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran Etexilate Capsules, 75 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran Etexilate Capsules, 75 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran etexilate Capsules, 110 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg recalledAmlodipine And Olmesartan Medoxomil | Ascend Laboratories | Potency & Assay | Nationwide |
Other Minocycline recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg* recalledMinocycline Hydrochloride | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Minocycline Hydrochloride Capsules USP, 100 mg* Dose blisters recalled | Apace KY | Labeling Errors | Nationwide |
| Drug | CLASS II | Minocycline HCL, Capsule, 50 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Minocycline HCL, Capsule, 100 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |