CLASS III Drug recall · Reported 21 Nov 2018 · FDA Enforcement Report
Megestrol Acetate Oral Suspension, USP 625 mg recalled
Breckenridge Pharmaceutical is recalling Megestrol Acetate Oral Suspension, USP 625 mg, distributed nationwide in the US. The recall was initiated on 6 Nov 2018 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-0279-2019
- FDA event ID
- 81523
- Recalling firm
- Breckenridge Pharmaceutical, Boca Raton, FL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Nov 2018
- FDA classified
- 20 Nov 2018
- Reported
- 21 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
Timeline
| 6 Nov 2018 | Recall initiated by company | |
| 20 Nov 2018 | Classified by FDA | +14 days |
| 21 Nov 2018 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability 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
Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487, Manufactured by: Pharmaceutics International Inc. Hunt Valley, MD 21031
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Which lots are affected?
Lot #: 5599.008A, 5599.009A, 5599.010A, Exp. 04/2019; 5599.012A, 5599.013A, Exp. 11/2019; 5599.014A, Exp. 01/2020
Where was it sold?
Nationwide within the United States
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 Breckenridge Pharmaceutical
All 35| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 30mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 60mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules USP, 60mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
Other Megestrol recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Megestrol Acetate Oral Suspension, USP 40 mg/mL recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Megestrol Acetate Oral Suspension, USP 400 mg/mL UD cups in boxes recalled | Mckesson | Packaging Defects | Nationwide |
| Drug | CLASS III | Megestrol Acetate Oral Suspension, USP 400 mg/ UD cups in boxes recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |