CLASS III Drug recall · Reported 12 Feb 2020 · FDA Enforcement Report
Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg* recalled
Ascend Laboratories is recalling Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, distributed nationwide in the US. The recall was initiated on 22 Jan 2020 and the FDA has classified it as Class III.
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-0827-2020
- FDA event ID
- 84750
- Recalling firm
- Ascend Laboratories, Parsippany, NJ
- Manufacturer
- Ascend Laboratories, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Jan 2020
- FDA classified
- 5 Feb 2020
- Reported
- 12 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 22 Jan 2020 | Recall initiated by company | |
| 5 Feb 2020 | Classified by FDA | +14 days |
| 12 Feb 2020 | Published in enforcement report | +7 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: low out of specification results for dissolution testing.
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, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Which lots are affected?
Lot #: 19140414, Exp 12/2020
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 II | Minocycline Hydrochloride Extended-Release Tablets, USP, 115 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 |