Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Ongoing Initiated Mar 21, 2025 (2 years ago)

Methocarbamol Injection USP 1

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility: Media fill with bacterial contamination

Cause type: Sterility / contamination

A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.

What was recalled

Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5x10 mL carton)

Affected NDCs 70069-0101-05 70069-0101-25

Compare with the code on your package — it is the most precise check available.

Drug: Methocarbamol

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Methocarbamol
NDC 70069-0101
100 mg/mL Injection
Intramuscular|intravenous
Somerset Therapeutics, LLC Rx
Recalling firm
Somerset Therapeutics Private Limited
NDC code
70069-101-25
Origin
N/A, India
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0354-2025 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.

Other Methocarbamol recalls

See all
Class I · High risk

Methocarbamol 500mg Tablet

Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets

Completed Labeling / mix-up Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals D-0092-2022
Class I · High risk

robaxin-750

Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."

Terminated Labeling / mix-up Endo Pharmaceuticals, Inc. NDC 52244-449-10 D-0009-2019

Other recalls by Somerset Therapeutics Private Limited

All 2025 recalls