Megestrol Acetate Oral Suspension — Class III drug recall D-0279-2019
Terminated recall by Breckenridge Pharmaceutical, Inc., reported 2018-11-21, distributed nationwide. Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during s
| Recall number | D-0279-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Breckenridge Pharmaceutical, Inc., Boca Raton, FL, United States |
| Recall initiated | 2018-11-06 |
| Classified | 2018-11-20 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2019-11-26 |
| Distributed | Nationwide (US) |
| Quantity | 9,193 bottles |
| Reason classes | specification failure |
| Lot numbers | 5599.008A, 5599.009A, 5599.010A, 5599.012A, 5599.013A, 5599.014A |
| Expiration dates | 2019-04, 2019-11, 2020-01 |
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 for recall
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0279-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.