FDA Drug recall D-0279-2019
Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc
- FDA Drug
- Class III
- terminated
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class III recall of Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc by Breckenridge Pharmaceutical, citing failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0279-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-11-06 |
| Published | 2018-11-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Breckenridge Pharmaceutical |
| Distribution | US |
Product
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
Reason
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Identifiers
| code_info | Lot #: 5599.008A, 5599.009A, 5599.010A, Exp. 04/2019; 5599.012A, 5599.013A, Exp. 11/2019; 5599.014A, Exp. 01/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2026-05-13 · Breckenridge Pharmaceutical - Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrel…
FDA Drug · Class II · 2025-12-10 · Breckenridge Pharmaceutical - Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrel…
FDA Drug · Class II · 2025-12-10 · Breckenridge Pharmaceutical
All Breckenridge Pharmaceutical recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0279-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.