Baclofen USP — Class II drug recall D-0476-2018
Terminated recall by American Pharmaceutical Ingredients LLC, reported 2018-02-28, distributed nationwide. CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiratio
| Recall number | D-0476-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Pharmaceutical Ingredients LLC, Waterford, MI, United States |
| Recall initiated | 2018-02-09 |
| Classified | 2018-02-22 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2019-12-02 |
| Distributed | Nationwide (US) |
| Quantity | 55,500 g |
| Reason classes | cgmp, specification failure |
| NDC | 58597-8004-04, 58597-8004-06, 58597-8004-07, 58597-8004-08 |
| Expiration dates | 2018-08-24, 2019-01-31 |
Product
Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8004-4); b)100g (NDC 58597-8004-6); c) 500g (NDC 58597-8004-7); d) 1000g (NDC 58597-8004-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
Reason for recall
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
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-0476-2018. 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.