CLASS II Drug recall · Reported 12 Jul 2017 · FDA Enforcement Report
Methocarbamol recalled by American Pharmaceutical
American Pharmaceutical Ingredients is recalling Methocarbamol, USP, distributed nationwide in the US. The recall was initiated on 26 May 2017 and the FDA has classified it as Class II.
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-0937-2017
- FDA event ID
- 77392
- Recalling firm
- American Pharmaceutical Ingredients, Waterford, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 May 2017
- FDA classified
- 2 Jul 2017
- Reported
- 12 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Compounded Drugs
Timeline
| 26 May 2017 | Recall initiated by company | |
| 2 Jul 2017 | Classified by FDA | +37 days |
| 12 Jul 2017 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Lack of quality assurance at the API manufacturer.
Product as listed by the FDA
Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 g container (NDC: 58597-8023-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Where it was distributed
Nationwide
Questions about this recall
Is Methocarbamol, USP recalled?
Yes. American Pharmaceutical Ingredients recalled Methocarbamol, USP on 26 May 2017. The recall is Class II and its status is Terminated. Recall number D-0937-2017.
Why was it recalled?
CGMP Deviations: Lack of quality assurance at the API manufacturer.
Which lots are affected?
Lots: MCMR1308029NS, MCMR1308029NS-4202015; Exp. 08/18
Where was it sold?
Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 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 American Pharmaceutical Ingredients
All 71| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sermorelin Acetate, powder, a) 1 GM-bottle b) 5 GM-bottle recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxytocin USP, powder-bottle, API American Pharmaceutical Ingredients recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
| Drug | CLASS II | Levocetirizine Dihydrochloride for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
| Drug | CLASS II | Itraconazole USP (Micronized) for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
| Drug | CLASS II | Ascorbic Acid USP, for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |