CLASS III Drug recall · Reported 15 Jul 2015 · FDA Enforcement Report

Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme recalled

BioComp Pharma is recalling Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle, distributed nationwide in the US. The recall was initiated on 6 Jul 2015 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: 4D040, Exp 4/2016
Quantity recalled40,000 sachets

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-1233-2015
FDA event ID
71576
Recalling firm
BioComp Pharma, San Antonio, TX
Classification
Class III
Status
Terminated
Recall initiated
6 Jul 2015
FDA classified
9 Jul 2015
Reported
15 Jul 2015
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Potency & Assay

Timeline

6 Jul 2015Recall initiated by company
9 Jul 2015Classified by FDA+3 days
15 Jul 2015Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Subpotent Drug: menthol and methyl salicylate below specification

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle Soreness, Arthritis, Back Aches; 1/8 Oz Sachet, OTC, Manufactured for Mission Pharmacal Company 10999 IH 10 West, Suite 1000 San Antonio, TX 78230 by Mission Pharmacal Company 38505 IH 10 West Boerne, TX 78006. NDC 0178-0320-12

Where it was distributed

Nationwide

Nationwide

Questions about this recall

Is Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle recalled?

Yes. BioComp Pharma recalled Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle on 6 Jul 2015. The recall is Class III and its status is Terminated. Recall number D-1233-2015.

Why was it recalled?

Subpotent Drug: menthol and methyl salicylate below specification

Which lots are affected?

Lot #: 4D040, Exp 4/2016

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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.